This section highlights FDA-related milestones and regulatory updates for drugs developed by PureTech Health (PRTC).
Over the past two years, PureTech Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LYT-200, SPT-320TM, SPT-300, LYT-100, LYT-100-COV, SPT-320, and VE202. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
LYT-200 FDA Regulatory Timeline and Events
LYT-200 is a drug developed by PureTech Health for the following indication: Difficult-to-Treat Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYT-200
- Announced Date:
- April 22, 2026
- Indication:
- Difficult-to-Treat Solid Tumors
Announcement
PureTech Health plc announced positive topline data from the completed Phase 1b clinical trial of LYT-200, a first-in-class, fully human anti-galectin-9 monoclonal antibody, in heavily pretreated patients with relapsed/refractory (R/R) high-risk (HR) myelodysplastic syndrome (MDS) and R/R acute myeloid leukemia (AML).
AI Summary
PureTech Health reported positive topline results from a completed Phase 1b trial of LYT-200, a fully human anti–galectin‑9 monoclonal antibody, in heavily pretreated patients with relapsed/refractory high‑risk myelodysplastic syndrome (R/R HR‑MDS) and relapsed/refractory acute myeloid leukemia (R/R AML). LYT‑200 showed favorable tolerability across both groups.
In R/R HR‑MDS, at the recommended Phase 2 dose (12 mg/kg with a hypomethylating agent) among 11 efficacy‑evaluable patients, outcomes included a 27.3% complete response rate, 9.1% partial response, 9.1% marrow complete response, and a 45.5% overall response rate. 18% of patients converted to transplant. Median overall survival was 6.4 months but is not mature because more than half of patients were alive at study end.
In R/R AML (26 efficacy‑evaluable patients) the 12 mg/kg dose with venetoclax/HMA showed activity; median overall survival was 8.2 months but remains immature. Patients were heavily pretreated (median two prior lines; 84.6% had prior venetoclax/HMA). Gallop Oncology will advance LYT‑200 first in R/R HR‑MDS, and PureTech plans to engage the U.S. FDA on a subsequent trial design that could support registration.
Read Announcement- Drug:
- LYT-200
- Announced Date:
- December 5, 2025
- Indication:
- Difficult-to-Treat Solid Tumors
Announcement
PureTech Health plc announced initial topline results from the Phase 1b clinical trial evaluating LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, in patients with relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
AI Summary
PureTech Health announced initial topline results from a Phase 1b trial of LYT-200, a first-in-class anti–galectin-9 monoclonal antibody, in patients with relapsed or refractory acute myeloid leukemia (AML) and high‑risk myelodysplastic syndrome (MDS). The trial evaluated safety, tolerability and early signs of clinical activity in a heavily pretreated population. LYT-200 is designed to target galectin‑9, a protein involved in immune suppression in the tumor microenvironment.
According to PureTech, the topline data showed an acceptable safety profile and early evidence of anti‑leukemic activity, including responses in some patients, supporting continued development. These results will guide dose selection and next steps, including expansion cohorts and later‑phase studies to better define efficacy and durability. The company said it plans to advance the program while collecting more data to understand LYT‑200’s potential in these difficult‑to‑treat blood cancers.
Read Announcement- Drug:
- LYT-200
- Announced Date:
- January 9, 2025
- Indication:
- Difficult-to-Treat Solid Tumors
Announcement
PureTech Health plc announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for the treatment of acute myeloid leukemia ("AML").
AI Summary
PureTech Health announced that the FDA has granted Fast Track designation to LYT-200, a new anti-galectin-9 monoclonal antibody, for the treatment of acute myeloid leukemia (AML). This Fast Track status is designed to speed up the development and review process for promising treatments that address serious health conditions. LYT-200 is being studied for its potential to not only kill cancer cells directly but also to boost the immune system’s ability to fight the disease. Early trial results have indicated that the treatment has shown a favorable safety profile and hints of clinical activity, whether used alone or alongside other therapies. The FDA’s decision highlights the need for new, effective treatment options for AML patients, and PureTech remains encouraged about expanding the potential benefits of LYT-200 for those facing this challenging cancer.
Read Announcement- Drug:
- LYT-200
- Announced Date:
- December 9, 2024
- Indication:
- Difficult-to-Treat Solid Tumors
Announcement
PureTech Health plc presented data from the dose escalation phase of its ongoing Phase 1b trial evaluating LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, in patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego, California.
AI Summary
PureTech Health plc presented promising data at the 2024 American Society of Hematology Annual Meeting from the dose escalation phase of its ongoing Phase 1b trial. The study is evaluating LYT-200, a new anti-galectin-9 antibody, in patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
LYT-200 is being tested both alone and in combination with standard treatments like venetoclax and hypomethylating agents. The early results show that the drug is generally well-tolerated with no severe safety issues across all tested doses. As a single treatment, nearly 60% of patients experienced stable disease or better, including some partial responses. When used with other therapies, complete responses were seen, and 80% of patients achieved stable disease or better. These findings suggest that LYT-200 could become a valuable treatment option for patients with these challenging blood disorders.
Read Announcement
SPT-320TM FDA Regulatory Events
SPT-320TM is a drug developed by PureTech Health for the following indication: oral prodrug of agomelatine in development for generalized anxiety disorder (GAD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SPT-320TM
- Announced Date:
- April 2, 2026
- Indication:
- oral prodrug of agomelatine in development for generalized anxiety disorder (GAD)
Announcement
PureTech Health plc announced positive topline data from portions of its ongoing Phase 1 proof-of-concept clinical trial evaluating GlyphAgoTM (SPT-320TM or Glyph Agomelatine). GlyphAgo is a novel, Glyphed oral prodrug of agomelatine in development for generalized anxiety disorder (GAD) and the second clinical-stage candidate from Seaport's pipeline.
AI Summary
PureTech Health plc announced positive topline data from portions of its ongoing Phase 1 proof-of-concept trial of GlyphAgo (SPT-320), a novel Glyphed oral prodrug of agomelatine being developed for generalized anxiety disorder (GAD). The results showed GlyphAgo achieved therapeutic agomelatine exposures at doses projected to avoid liver enzyme elevations and to reduce or eliminate routine liver function testing, and it was well tolerated with no serious, severe, or liver-related adverse events reported.
Pharmacokinetic findings included a 6.8-fold increase in bioavailability versus unmodified agomelatine, exceeding the program’s 2-fold target, and a roughly 10-fold reduction in PK variability. Based on these data, Seaport plans two parallel trials: a Phase 2a proof-of-pharmacology study to assess potential sleep benefits in GAD, and a Phase 2b randomized, placebo-controlled, registration-enabling trial. Additional Phase 1 analyses, including MAD results, will be shared at upcoming scientific meetings.
Read Announcement
SPT-300 FDA Regulatory Timeline and Events
SPT-300 is a drug developed by PureTech Health for the following indication: For the treatment of mood and anxiety disorders, including anxious depression.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SPT-300
- Announced Date:
- March 25, 2026
- Indication:
- For the treatment of mood and anxiety disorders, including anxious depression
Announcement
PureTech Health plc announced the publication of first-in-human clinical and preclinical data for GlyphAllo™ (SPT-300 or Glyph Allopregnanolone) in Science Translational Medicine.
AI Summary
PureTech Health plc announced the publication of first‑in‑human clinical and preclinical data for GlyphAllo™ (SPT‑300 or Glyph Allopregnanolone) in Science Translational Medicine. The report shows GlyphAllo is a triglyceride‑mimetic prodrug that achieved therapeutically relevant drug levels in humans after oral dosing. Preclinical and early human results support the idea that the Glyph™ platform can overcome key delivery limits of the parent compound and enable effective oral therapy.
The findings helped advance an ongoing Phase 2b clinical trial of GlyphAllo in major depressive disorder (MDD). The Glyph program and platform were initially developed at PureTech and are now being advanced by Seaport Therapeutics, a PureTech‑founded entity. Overall, the published data provide clinical validation that the Glyph approach can enable oral delivery of compounds that were previously difficult to dose, supporting further clinical development in mood disorders.
Read Announcement- Drug:
- SPT-300
- Announced Date:
- July 17, 2025
- Indication:
- For the treatment of mood and anxiety disorders, including anxious depression
Announcement
PureTech Health plc announced that the first patient has been dosed in the Phase 2b BUOY-1 study of GlyphAllo™ SPT-300 or Glyph Allopregnanolone) in major depressive disorder (MDD) with or without anxious distress.
AI Summary
PureTech Health plc announced that the first patient has been dosed in the Phase 2b BUOY-1 study of GlyphAllo™ (SPT-300), an innovative oral prodrug of allopregnanolone. This treatment targets major depressive disorder (MDD) with or without anxious distress. GlyphAllo is designed to overcome previous challenges with allopregnanolone’s bioavailability, aiming to provide rapid antidepressant and anxiolytic benefits.
The BUOY-1 study builds on strong Phase 1 and Phase 2a data, showing that GlyphAllo safely achieves effective brain levels of allopregnanolone. This global, randomized, double-blind, placebo-controlled trial will evaluate the drug’s efficacy, safety, and tolerability in adults suffering from MDD. The initiation of this study marks a significant milestone in the journey towards developing a potential first-in-class treatment for patients experiencing depression and anxiety symptoms.
Read Announcement- Drug:
- SPT-300
- Announced Date:
- December 11, 2024
- Indication:
- For the treatment of mood and anxiety disorders, including anxious depression
Announcement
PureTech Health plc announced the presentation of additional data from its first-in-human, multi-part Phase 1 study of SPT-300 in healthy volunteers at the American College of Neuropsychopharmacology (ACNP) Annual Meeting, held December 8-11, 2024 in Phoenix, Arizona. S
AI Summary
PureTech Health plc recently presented new data from its first-in-human, multi-part Phase 1 study of SPT-300 at the American College of Neuropsychopharmacology Annual Meeting in Phoenix, Arizona (December 8-11, 2024). The study involved healthy volunteers and showed that several well-tolerated doses produced clear biological effects. SPT-300 is an oral prodrug designed to turn into allopregnanolone, a substance known for its rapid antidepressant and anxiety-reducing benefits.
The additional data highlighted the drug’s safety profile and its ability to affect brain activity and eye movement, with any side effects being mild and short-lived. Based on these promising results, the company plans a Phase 2b placebo-controlled study to further examine SPT-300’s use for major depressive disorder, potentially offering a new, convenient treatment option.
Read Announcement
LYT-100 FDA Regulatory Timeline and Events
LYT-100 is a drug developed by PureTech Health for the following indication: Idiopathic Pulmonary Fibrosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYT-100
- Announced Date:
- December 8, 2025
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc announced the successful completion of the End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of deupirfenidone (LYT-100) for the treatment of idiopathic pulmonary fibrosis (IPF).
AI Summary
PureTech Health announced that its Founded Entity, Celea Therapeutics, completed a productive End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration. The FDA’s feedback supports advancing deupirfenidone (LYT‑100) into a pivotal Phase 3 trial and pursuing a 505(b)(2) regulatory pathway. Company leaders said the discussion clarified key elements of the Phase 3 program and the data needed for registration, helping shape the trial design and expectations for confirmatory results.
The planned Phase 3 SURPASS‑IPF study will be a global, randomized, double‑blind, head‑to‑head trial comparing deupirfenidone 825 mg TID versus pirfenidone 801 mg TID, with the primary endpoint of change in absolute forced vital capacity (FVC) at week 52. Based on FDA guidance, PureTech believes a successful single Phase 3 trial, together with the overall deupirfenidone data package, could be sufficient to support potential approval via a streamlined 505(b)(2) route. The trial is on track to begin in the first half of 2026.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- October 22, 2025
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc announced the presentation of new analyses from the Phase 2b ELEVATE IPF trial of deupirfenidone (LYT-100) for the treatment of idiopathic pulmonary fibrosis (IPF).
AI Summary
PureTech Health plc presented new analyses from its Phase 2b ELEVATE IPF trial of deupirfenidone (LYT-100) at the CHEST 2025 Annual Meeting. The study evaluated safety and efficacy of two doses of deupirfenidone compared with placebo and pirfenidone in patients with idiopathic pulmonary fibrosis (IPF).
Results showed that both younger patients and those aged 75 and older experienced similar rates of treatment-emergent adverse events, including gastrointestinal issues like nausea. Efficacy findings also remained consistent across age groups, reinforcing the drug’s favorable profile in stabilizing lung function decline over at least 26 weeks.
Dr. Tejaswini Kulkarni noted that older people with IPF have often been undertreated due to tolerability concerns. Demonstrating comparable safety and benefit in this demographic highlights deupirfenidone’s potential to serve a broader patient population.
These findings support deupirfenidone’s differentiated profile and its promise to fill an unmet need by offering an effective, well-tolerated option for a vulnerable, underrepresented group of IPF patients.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- August 21, 2025
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc demonstrated its growing leadership in idiopathic pulmonary fibrosis (IPF) at the 2025 IPF Summit this week in Boston. The Company highlighted the strength of its Phase 2b ELEVATE IPF trial data supporting the advancement of deupirfenidone (LYT-100) into Phase 3 by its newest Founded Entity, Celea Therapeutics ("Celea"), and shared new patient preference data and insights shaped by deep engagement across the IPF treatment ecosystem.
AI Summary
At the 2025 IPF Summit in Boston, PureTech Health plc showcased its leadership in idiopathic pulmonary fibrosis (IPF). The company highlighted strong Phase 2b ELEVATE IPF trial results for deupirfenidone (LYT-100), which showed a significant slowing of lung function decline at 26 weeks. Based on these data, its newest Founded Entity, Celea Therapeutics, will advance the therapy into Phase 3 studies as a potential new standard of care.
PureTech also shared new patient preference research involving 16 individuals with IPF. The survey revealed that 69% of participants would choose a treatment with greater efficacy over improved tolerability, and 94% said they would discuss a novel option with their doctor. These insights will shape clinical trial design and support a patient-focused Phase 3 strategy.
PureTech emphasized collaboration with patients, clinicians, and payers to guide clinical trial design and improve access.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- May 20, 2025
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, delivered a late-breaking, oral presentation at the 2025 American Thoracic Society (ATS) International Conference in San Francisco.
AI Summary
PureTech Health plc, a clinical-stage biotherapeutics company focused on improving the lives of patients with serious diseases, presented late-breaking data at the 2025 American Thoracic Society International Conference in San Francisco. In this oral presentation, the company highlighted key findings from its Phase 2b ELEVATE IPF trial, showing that deupirfenidone slowed lung function decline in patients with idiopathic pulmonary fibrosis. The treatment effect was notable for aligning the rate of decline in patients with that seen in healthy older adults, and preliminary open-label extension data suggested that these benefits are durable for at least 52 weeks. The company emphasized the favorable safety and tolerability of deupirfenidone, indicating its potential as a meaningful, differentiated treatment for IPF. PureTech’s data and commitment underline their mission to change patient outcomes in devastating diseases.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- May 1, 2025
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc announced that the Company will deliver a late-breaking oral presentation at the upcoming American Thoracic Society (ATS) International Conference, taking place in San Francisco, California, from May 16-21, 2025.
AI Summary
PureTech Health plc announced it will deliver a late-breaking oral presentation at the upcoming American Thoracic Society International Conference in San Francisco, California, from May 16-21, 2025. The presentation will share key data from the Phase 2b ELEVATE IPF trial, which evaluated deupirfenidone as a treatment for idiopathic pulmonary fibrosis (IPF). Early results from the trial suggest that deupirfenidone may help stabilize lung function decline over 26 weeks while maintaining a favorable safety and tolerability profile. This evidence supports the drug’s potential to become a new standard of care for patients suffering from IPF, a serious and progressive lung disease. By highlighting these promising outcomes, PureTech aims to bolster confidence in deupirfenidone’s effectiveness, paving the way for its advancement into Phase 3 development and future discussions with regulatory authorities.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- December 16, 2024
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc announced positive results from ELEVATE IPF, a Phase 2b randomized, double-blind, active- and placebo-controlled, dose-ranging trial evaluating deupirfenidone (LYT-100) at two dose levels three times a day (TID) over 26 weeks in patients with idiopathic pulmonary fibrosis (IPF).
AI Summary
PureTech Health recently announced positive results from its Phase 2b ELEVATE IPF trial studying deupirfenidone (LYT-100) in patients with idiopathic pulmonary fibrosis (IPF). In this study, patients received either 550 mg or 825 mg three times a day for 26 weeks. The trial was carefully designed using both active and placebo controls, and it compared deupirfenidone to the standard treatment pirfenidone.
The results showed a clear dose-dependent effect. The higher dose of 825 mg significantly slowed lung function decline to nearly normal levels, with a treatment effect of 80.9% versus placebo—much greater than the 54.1% effect seen with pirfenidone. Moreover, deupirfenidone was well tolerated, demonstrating a favorable safety profile. These promising findings support the further development of deupirfenidone as a potential new treatment option for IPF.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- October 9, 2024
- Target Action Date:
- LATE 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc announced that Topline data from the Phase 2b ELEVATE IPF trial of LYT-100 expected by the end of 2024
AI Summary
PureTech Health plc announced that topline data from its Phase 2b ELEVATE IPF trial of LYT-100 is expected by the end of 2024. The trial is a randomized, double-blind, placebo-controlled study in patients with idiopathic pulmonary fibrosis (IPF). It uses a prespecified Bayesian approach that leverages historical placebo data to enhance statistical power while reducing the number of patients on placebo. LYT-100, a deuterated form of pirfenidone, is designed to improve tolerability and effectiveness compared to the current standard-of-care treatments. The study will assess the rate of decline in forced vital capacity over a 26-week period and compare two different doses of LYT-100 against placebo. If the results are positive, PureTech intends to advance the program into a Phase 3 trial, potentially offering a new treatment option for IPF patients.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- October 9, 2024
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc presented two oral presentations and one poster supporting its clinical and patient engagement strategies related to LYT-100 (deupirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF) at the CHEST 2024 Annual Meeting in Boston, Massachusetts.
AI Summary
At the CHEST 2024 Annual Meeting in Boston, PureTech Health plc presented two oral talks and one poster about its work on LYT-100 (deupirfenidone), a treatment in development for idiopathic pulmonary fibrosis (IPF). These presentations highlighted the company’s clinical strategies and patient engagement efforts aimed at addressing the significant challenges faced by individuals with IPF. The research focused on how LYT-100 may improve symptom management and support patient care by providing a potential new treatment option that targets key limitations of current therapies. PureTech’s work is set against the backdrop of a decade since the first antifibrotic drugs were approved, with the company emphasizing the need for better management of IPF symptoms and improved quality of life. The presentations underline PureTech’s commitment to advancing IPF treatment through innovative research and patient-focused clinical strategies.
Read Announcement- Drug:
- LYT-100
- Announced Date:
- October 1, 2024
- Indication:
- Idiopathic Pulmonary Fibrosis
Announcement
PureTech Health plc announced its onsite presence at the CHEST 2024 Annual Meeting in Boston, Massachusetts, from October 6-9.
AI Summary
PureTech Health announced that it will be onsite at the CHEST 2024 Annual Meeting in Boston, Massachusetts, from October 6-9, 2024. During the event, the company will showcase key data and insights related to LYT-100 (deupirfenidone), a potential treatment for idiopathic pulmonary fibrosis (IPF). PureTech will deliver two oral presentations and one poster presentation focusing on various aspects of IPF management, including the patient experience and the current challenges associated with treatment. The presentations aim to share valuable research findings that have shaped the clinical and commercial strategies for LYT-100. Additionally, with topline data expected later this year from the Phase 2b ELEVATE IPF trial, the company anticipates that successful outcomes could support further development into a Phase 3 trial. This progress could potentially lead to LYT-100 becoming a registered treatment option in the U.S. and other regions.
Read Announcement
LYT-100-COV (deupirfenidone) FDA Regulatory Events
LYT-100-COV (deupirfenidone) is a drug developed by PureTech Health for the following indication: Post-acute Long COVID with respiratory complications.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYT-100-COV (deupirfenidone)
- Announced Date:
- September 29, 2025
- Indication:
- Post-acute Long COVID with respiratory complications
Announcement
PureTech Health plc announced new data from the open-label extension (OLE) of its Phase 2b ELEVATE IPF trial of deupirfenidone (LYT-100) in people living with idiopathic pulmonary fibrosis (IPF).
AI Summary
PureTech Health plc announced new data from the open-label extension (OLE) of its Phase 2b ELEVATE IPF trial of deupirfenidone (LYT-100) in people living with idiopathic pulmonary fibrosis (IPF). In this extension, 170 participants (over 90% of those completing the blinded phase) who switched to deupirfenidone 825 mg three times daily after 26 weeks on placebo or pirfenidone showed stabilized lung function. The placebo-to-deupirfenidone group had a mean forced vital capacity (FVC) gain of +20 mL, while the pirfenidone-to-deupirfenidone group had a mean decline of –23 mL over the 26-week extension.
These findings reinforce results from the initial 26-week study and suggest a durable treatment effect comparable to the natural FVC decline in healthy older adults. Deupirfenidone was well tolerated, with common side effects including nausea, dyspepsia, upper respiratory infections, and cough, mirroring earlier safety data.
PureTech is actively engaging with regulators and expects to finalize its Phase 3 trial design by Q4 2025, aiming to establish deupirfenidone as a potential new standard of care for IPF.
Read Announcement
SPT-320 FDA Regulatory Events
SPT-320 is a drug developed by PureTech Health for the following indication: to treat generalized anxiety disorder.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SPT-320
- Announced Date:
- September 11, 2025
- Indication:
- to treat generalized anxiety disorder
Announcement
PureTech Health plc announced that the first participant has been dosed in the Phase 1 study of GlyphAgo™ (SPT-320 or Glyph Agomelatine).
AI Summary
PureTech Health plc’s founded entity, Seaport Therapeutics, has dosed the first participant in a Phase 1 study of GlyphAgo™ (SPT-320 or Glyph Agomelatine). This marks the second candidate from Seaport’s pipeline to enter clinical development. The study is being conducted in healthy adult volunteers.
GlyphAgo is an oral prodrug of agomelatine, a drug already shown to work well in generalized anxiety disorder (GAD). Seaport’s Glyph™ platform shifts absorption into the intestinal lymphatic system. This helps the drug avoid first-pass liver metabolism and increases its overall exposure in the body.
The Phase 1 proof-of-concept trial will assess safety, tolerability, and pharmacokinetics. It includes single- and multiple-ascending dose phases, plus a food-effect crossover part. Researchers aim to show that therapeutic drug levels can be reached at lower doses with less liver exposure.
By reducing liver metabolism, GlyphAgo may lower the risk of liver enzyme elevations and cut down on monitoring needs. If successful, this approach could deliver agomelatine’s benefits with an improved safety profile.
The study’s results will help determine whether GlyphAgo can redefine GAD treatment for patients worldwide.
Read Announcement
VE202 FDA Regulatory Events
VE202 is a drug developed by PureTech Health for the following indication: Inflammatory Bowel Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VE202
- Announced Date:
- August 13, 2025
- Indication:
- Inflammatory Bowel Disease
Announcement
PureTech Health plc announced that its candidate VE202 did not meet the primary endpoint in the Phase 2 COLLECTiVE202 study for the treatment of patients with mild-to-moderate ulcerative colitis (UC).
AI Summary
Vedanta Biosciences today announced that VE202, their live biotherapeutic candidate for mild-to-moderate ulcerative colitis, did not meet the primary endpoint of endoscopic response in the Phase 2 COLLECTiVE202 study. Although VE202 was generally well tolerated with no treatment-related serious adverse events, the observed rates were not statistically different from placebo.
The company expressed disappointment that VE202 failed to show efficacy, noting the strong interest in microbiome-based treatments for inflammatory bowel disease. Vedanta plans to present additional analyses of bacterial colonization, histology, and immune response at upcoming scientific meetings to guide future research in this area.
Vedanta will now focus its resources on its lead program, VE303, which is in a global Phase 3 study assessing prevention of recurrent Clostridioides difficile infection. Data from this trial will determine the path forward for VE303 as a potential new treatment for CDI.
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Glyph FDA Regulatory Events
Glyph is a drug developed by PureTech Health for the following indication: lymphatic system.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Glyph
- Announced Date:
- February 12, 2025
- Indication:
- lymphatic system
Announcement
PureTech Health plc noted that its Founded Entity, Seaport Therapeutics announced the publication of new data showcasing the GlyphTM platform's unique ability to enhance drug transport through the lymphatic system for increased therapeutic exposure.
AI Summary
PureTech Health plc recently announced that its Founded Entity, Seaport Therapeutics, published new data demonstrating the unique benefits of the Glyph™ platform. The study, featured in Molecular Pharmaceutics, showed that a novel prodrug attachment point on an immunomodulatory drug resulted in the highest reported lymphatic transport to date—about 55 percent drug absorption via the lymphatic system.
The research revealed that the new linkers released up to twice as much drug in the lymph nodes compared to previous attachment methods, enhancing direct access to the immune system. These findings support the idea that tailoring drug attachment sites can improve lymphatic drug delivery and overall therapeutic exposure, reinforcing the versatility and potential of the Glyph™ platform in the development of more effective treatments.
Read Announcement
VE303 FDA Regulatory Events
VE303 is a drug developed by PureTech Health for the following indication: Recurrent C. difficile infection (CDI).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VE303
- Announced Date:
- January 27, 2025
- Indication:
- Recurrent C. difficile infection (CDI)
Announcement
PureTech Health plc announced the publication of additional results from the Phase 2 CONSORTIUM study for its lead candidate, VE303, which is being evaluated for prevention of recurrent Clostridioides difficile infection (rCDI).
AI Summary
PureTech Health plc announced that additional results from the Phase 2 CONSORTIUM study for VE303 have been published in Nature Medicine. The study shows that VE303, a potential new treatment to prevent recurrent Clostridioides difficile infections, is well tolerated by patients. Researchers found that VE303 works through multiple mechanisms, including restoring a healthy balance of gut bacteria, reducing inflammation, and boosting levels of protective chemicals. The treatment, made up of eight carefully selected bacterial strains, was shown to lower the odds of infection coming back. Importantly, the study also identified factors that predict how well the bacteria can colonize the gut, which in turn relates to clinical benefits. These insights have helped guide the design and dose selection for the global Phase 3 RESTORATiVE303 study, with topline results expected in 2026.
Read Announcement- Drug:
- VE303
- Announced Date:
- May 21, 2024
- Indication:
- Recurrent C. difficile infection (CDI)
Announcement
PureTech Health plc announced that the first patient has been dosed in the global Phase 3 RESTORATiVE303 clinical study of VE303, which is an orally administered defined bacterial consortium candidate that is being developed for the prevention of recurrent C. difficile infection (rCDI).
AI Summary
PureTech Health plc announced that the first patient has been dosed in the global Phase 3 RESTORATiVE303 study for VE303. This trial is a pivotal step in developing VE303, an orally administered bacterial consortium candidate designed to prevent recurrent Clostridioides difficile infection (rCDI). Developed by Vedanta Biosciences, a PureTech Founded Entity, VE303 represents a potential first-in-class live biotherapeutic product. The study will assess the efficacy and safety of VE303 in patients at high risk for rCDI and is intended to support a Biologics License Application with the U.S. Food and Drug Administration. This clinical milestone marks a significant advancement in treatment options for rCDI, offering hope for more effective and targeted care compared to traditional, donor-derived fecal therapies.
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KarXT (xanomeline-trospium) FDA Regulatory Events
KarXT (xanomeline-trospium) is a drug developed by PureTech Health for the following indication: Healthy Elderly Volunteers.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KarXT (xanomeline-trospium)
- Announced Date:
- January 17, 2025
- Indication:
- Healthy Elderly Volunteers
Announcement
Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults.
AI Summary
Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted their New Drug Application for KarXT, which is being developed to treat schizophrenia in adults. This important step could bring a new treatment option to over 8 million Chinese patients who currently face challenges with available therapies. Clinical trials have shown that KarXT significantly reduces symptoms of schizophrenia while offering a safety profile that is manageable. The acceptance of the application indicates that regulators see potential in this novel treatment approach, which could help patients experience fewer side effects compared to current medications. If approved, KarXT may pave the way for a fresh and innovative method to manage schizophrenia, potentially improving the quality of life for many patients in China and possibly influencing treatment practices globally.
Read Announcement- Drug:
- KarXT (xanomeline-trospium)
- Announced Date:
- September 27, 2024
- Indication:
- Healthy Elderly Volunteers
Announcement
PureTech Health plc announced that KarXT (xanomeline and trospium chloride), which was initially invented and advanced by PureTech, has received U.S. Food and Drug Administration ("FDA") approval for the treatment of schizophrenia in adults.
AI Summary
PureTech Health plc announced that its drug KarXT—a combination of xanomeline and trospium chloride—has received U.S. FDA approval for treating schizophrenia in adults. Originally invented and developed by PureTech, KarXT overcomes previous tolerability issues, paving the way for a novel approach to treating neuropsychiatric conditions. With this approval, milestone payments worth $29 million have been triggered under agreements with Royalty Pharma and Karuna Therapeutics, the latter of which was acquired by Bristol Myers Squibb in March 2024.
Marketed by Bristol Myers Squibb under the name Cobenfy, this breakthrough marks a significant advancement in addressing schizophrenia with a treatment that represents the first new drug mechanism approved for the condition in over 50 years. PureTech’s innovation in drug development continues to demonstrate its impact on both clinical outcomes and future financial growth.
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