This section highlights FDA-related milestones and regulatory updates for drugs developed by Protara Therapeutics (TARA).
Over the past two years, Protara Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TARA-002, Intravenous, and THRIVE-1. 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.
TARA-002 FDA Regulatory Timeline and Events
TARA-002 is a drug developed by Protara Therapeutics for the following indication: Non-Muscle Invasive Bladder Cancer.
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:
- TARA-002
- Announced Date:
- April 27, 2026
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc announced that updated, interim data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial evaluating TARA-002 in patients with BCG-Naïve non-muscle invasive bladder cancer (NMIBC) will be featured during a poster session at the upcoming American Urological Association (AUA) 2026 Annual Meeting taking place from May 15, 2026 to May 18, 2026 in Washington, DC.
AI Summary
Protara Therapeutics announced that updated, interim data from Cohort A of its ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in BCG‑naïve non‑muscle invasive bladder cancer (NMIBC) will be featured in a poster session at the American Urological Association (AUA) 2026 Annual Meeting in Washington, DC, May 15–18, 2026. The presentation will cover Cohort A, which enrolls patients who have not previously received BCG therapy, and will provide an interim look at the investigational agent’s performance in that population.
TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK‑432 (Picibanil®) and Protara has shown manufacturing comparability between the two. NMIBC accounts for about 80% of U.S. bladder cancer diagnoses, roughly 65,000 patients annually, underscoring the clinical interest in new intravesical therapies like TARA-002.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- February 23, 2026
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. announced updated interim results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company's investigational cell-based therapy, in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve.
AI Summary
Protara Therapeutics reported updated interim results from its Phase 2 open-label ADVANCED-2 trial testing intravesical TARA-002, a cell-based therapy, in patients with high‑risk non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) ± Ta/T1 who are BCG‑Unresponsive or BCG‑Naïve.
As of the January 28, 2026 data cutoff, the BCG‑Unresponsive cohort had 35 evaluable participants (22 evaluable at six months and 15 at 12 months). The BCG‑Naïve interim analysis included 29 evaluable participants (27 at six months and 19 at 12 months); enrollment in the BCG‑Naïve cohort is complete with 31 patients total.
Safety was favorable: most treatment‑related adverse events (TRAEs) were Grade 1 and transient. There were no Grade 3 or greater TRAEs, no related serious adverse events, and no treatment discontinuations due to TRAEs. Common effects were dysuria, bladder spasm, fatigue and urgency, typically resolving within hours to days.
Protara expects to finish enrolling the BCG‑Unresponsive registrational cohort in the second half of 2026 and plans to initiate the ADVANCED‑3 trial in BCG‑Naïve patients in 2H 2026.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- January 22, 2026
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. announced that updated interim data from the cohort of BCG-Unresponsive non-muscle invasive bladder cancer (NMIBC) patients in the ongoing Phase 2 ADVANCED-2 trial of TARA-002 will be featured at the upcoming American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, taking place from February 26, 2026 to February 28, 2026 in San Francisco.
AI Summary
Protara Therapeutics announced that updated interim data from the BCG‑Unresponsive non‑muscle invasive bladder cancer (NMIBC) cohort in its Phase 2 ADVANCED‑2 trial of TARA‑002 will be presented at the ASCO Genitourinary Cancers Symposium in San Francisco, Feb. 26–28, 2026. The poster will show updated safety and efficacy results from about 25 six‑month evaluable BCG‑Unresponsive NMIBC patients. Presentation details include Poster F15, “ADVANCED‑2: Interim efficacy and safety data in BCG‑Unresponsive participants,” scheduled for Friday, Feb. 27, 2026. An additional poster (H8) will present interim safety and tolerability data from both BCG‑Naïve and BCG‑Unresponsive patients the same day.
ADVANCED‑2 is an open‑label Phase 2 trial testing intravesical TARA‑002 in NMIBC patients with carcinoma in situ (± Ta/T1), with Cohort B planned for 75–100 BCG‑Unresponsive patients and Cohort A for about 31 BCG‑Naïve patients. Dosing includes six weekly induction instillations (with optional reinduction) and maintenance three weekly instillations every three months. TARA‑002 is an investigational cell‑based immunotherapy designed to stimulate local immune responses and target tumor cells in the bladder.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- January 5, 2026
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations for TARA-002, the Company's investigational cell-based therapy, for the treatment of pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs).
AI Summary
Protara Therapeutics announced that the U.S. Food and Drug Administration has granted both Breakthrough Therapy and Fast Track designations for TARA-002, the company’s investigational cell-based therapy, for treating pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs). The company said these designations reflect the significant unmet need in this young patient group and that TARA-002 could become a meaningful treatment option. Protara plans to meet with the FDA in the first half of the year to define the path to registration for TARA-002 in LMs.
The FDA also selected TARA-002 to participate in the CMC Development and Readiness Pilot (CDRP) Program, which supports chemistry, manufacturing, and controls work for products with expedited development timelines. Participation in CDRP is intended to help streamline manufacturing scale-up and promote earlier patient access while clinical development continues. Protara sees these regulatory actions as steps toward accelerating development and review for this underserved pediatric population.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- January 5, 2026
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations for TARA-002, the Company's investigational cell-based therapy, for the treatment of pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs).
AI Summary
Protara Therapeutics announced the U.S. Food and Drug Administration has granted both Breakthrough Therapy and Fast Track designations to TARA-002, its investigational cell-based therapy for pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs). These designations are meant to speed development and regulatory review for treatments that may address serious conditions with unmet medical needs.
The FDA also selected TARA-002 to participate in the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program to support manufacturing planning while clinical development continues. Protara said it will work closely with the agency to define a path toward registration and aims to move the program forward as efficiently as possible to help patients sooner.
TARA-002 is an inactivated, immune-stimulating cell-based product being developed specifically for pediatric LMs. The company is advancing clinical and manufacturing efforts to evaluate safety and effectiveness and to prepare for scaled production if trials are successful.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- December 3, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. announced updated interim data from the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS (± Ta/T1) non-muscle invasive bladder cancer (NMIBC).
AI Summary
Protara Therapeutics reported updated interim data from the Phase 2 ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ (CIS ± Ta/T1) non-muscle invasive bladder cancer who were BCG‑naïve. The dataset included 31 treated patients, 29 of whom were evaluable for efficacy. Patients received six weekly intravesical induction doses, followed by maintenance doses of three weekly instillations every three months; re‑induction was allowed for some patients.
Results showed a complete response (CR) rate at any time of 72% (21/29), a 6‑month CR of 69% (18/26), and a 12‑month CR of 50% (7/14). Among initial responders, 88% maintained response through six months and 100% through 12 months. Re‑induction converted most initial non‑responders: 80% (4/5) achieved CR at six months, with all (4/4) of those maintaining CR at 12 months.
TARA‑002 was generally well tolerated; most treatment‑related adverse events were Grade 1 and transient, with no Grade 3 or higher events reported and no treatment discontinuations due to adverse events. Common side effects included dysuria (13%), fatigue (13%), and hematuria (6%). Protara plans interim reporting for the BCG‑unresponsive cohort in Q1 2026 and expects to complete enrollment of that cohort in the second half of 2026.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- December 1, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. announced that it will host a conference call and live webcast at 8:30 am ET on Wednesday, December 3, 2025, to review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in BCG-Naïve patients with non-muscle invasive bladder cancer (NMIBC).
AI Summary
Protara Therapeutics announced it will hold a conference call and live webcast at 8:30 am ET on Wednesday, December 3, 2025, to review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in BCG‑naïve patients with non‑muscle invasive bladder cancer (NMIBC). The company says the update will focus on the trial’s interim findings.
The data will also be highlighted during a poster session at the 26th Annual Meeting of the Society of Urologic Oncology (SUO). Protara said it will provide an update on feedback from the U.S. Food and Drug Administration regarding a registrational path forward for TARA‑002 in BCG‑naïve patients.
Investors and the public can join the live event and view slides via Protara’s webcast registration page (https://protara-therapeutics-suo-update-call.open-exchange.net/registration) or the Events and Presentations section of the company website (https://ir.protaratx.com). A replay will be archived for a limited time after the event.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- November 18, 2025
- Target Action Date:
- November 19, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. announced it will host a conference call and live webcast at 8:30 a.m. ET on Wednesday, November 19, 2025, to review new data from an interim analysis of the ongoing Phase 2 open-label STARBORN-1 trial assessing TARA-002, the Company's investigational cell-based therapy, in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs).
AI Summary
Protara Therapeutics will host a conference call and live webcast at 8:30 a.m. ET on Wednesday, November 19, 2025 to review new data from an interim analysis of the ongoing Phase 2 open-label STARBORN-1 trial. The trial is evaluating TARA-002, the company’s investigational cell‑based therapy, in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs).
TARA-002 is an inactivated, genetically distinct strain of Streptococcus pyogenes designed to retain immune‑stimulating properties. It is being tested for its potential to reduce symptoms and complications of LMs, which are congenital lymphatic vessel malformations that often appear in early childhood and can cause airway obstruction, infection, bleeding, and functional or cosmetic problems.
The live event and slides can be accessed via Protara’s registration page (https://protara-therapeutics-update-call.open-exchange.net/registration) or the Events and Presentations section of the company website (https://ir.protaratx.com). A replay will be archived for a limited time after the webcast.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- November 17, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. announced that interim data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in BCG-Naïve patients with non-muscle invasive bladder cancer (NMIBC) will be featured during a poster session at the upcoming 26th Annual Meeting of the Society of Urologic Oncology (SUO) taking place from December 2, 2025 to December 5, 2025, in Phoenix, Arizona.
AI Summary
Protara Therapeutics announced that interim data from Cohort A of the Phase 2 open‑label ADVANCED‑2 trial of TARA‑002 in BCG‑naïve patients with non‑muscle invasive bladder cancer (NMIBC) will be presented as a poster at the 26th Annual Meeting of the Society of Urologic Oncology in Phoenix, Dec. 2–5, 2025. The poster (No. 149) in the Bladder Cancer session is scheduled for Thursday, Dec. 4, 2:30–3:30 p.m. CT and will include the abstract plus updated safety and efficacy data from 31 enrolled BCG‑naïve patients, most of whom have reached the six‑month evaluation point.
ADVANCED‑2 is evaluating intravesical TARA‑002 in NMIBC patients with carcinoma in situ (± Ta/T1), including roughly 100 BCG‑unresponsive and 31 BCG‑naïve participants. Treatment includes an induction course of six weekly instillations (with optional reinduction) followed by maintenance three weekly instillations every three months.
The poster will offer early safety and efficacy insights on TARA‑002 in this BCG‑naïve NMIBC group and help guide future development decisions.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- April 26, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. announced updated results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company's investigational cell-based therapy, in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients with carcinoma in situ, or CIS (± Ta/T1), who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve.
AI Summary
Protara Therapeutics announced updated results from its ongoing Phase 2 open-label ADVANCED-2 trial. The trial is testing TARA-002, an investigational cell-based therapy, in high-risk non-muscle invasive bladder cancer patients with carcinoma in situ (CIS) who are either Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve.
For the BCG-Unresponsive group, the complete response rate reached 100% at any time, with 67% maintaining a complete response at 12 months. In the BCG-Naïve group, 76% achieved a complete response at any time, with 43% sustaining it at 12 months. The therapy showed a favorable safety profile with no Grade 3 or higher treatment-related adverse events, and it was easily integrated into the current clinical workflow. The company plans to update the trial data at the end of 2025 with additional evaluable patients.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- April 23, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics announced it will host a conference call and live webcast at 8:30 a.m. ET on Monday, April 28, 2025, to review updated safety and efficacy data from the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC), including data from patients who have reached the 12-month evaluation timepoint.
AI Summary
Protara Therapeutics, Inc. announced that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, April 28, 2025. During the event, the company will review updated safety and efficacy data from its ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002. This trial focuses on treating non-muscle invasive bladder cancer (NMIBC) and includes data from patients who have reached the 12-month evaluation timepoint.
The live session will provide an overview of how TARA-002 is performing in terms of safety and its potential effectiveness in reducing tumor activity. Participants can register to receive dial-in details for the conference call or follow the webcast on the company’s website, offering an interactive way to gain more insight into the trial’s progress.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- April 10, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. announced that two presentations and a panel discussion highlighting the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) will be featured at the upcoming American Urological Association (AUA) 2025 Annual Meeting taking place from April 26, 2025 to April 29, 2025 in Las Vegas.
AI Summary
Protara Therapeutics, Inc. announced it will feature two presentations and a panel discussion on its Phase 2 open-label ADVANCED-2 trial at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas. The trial evaluates the investigational cell therapy TARA-002 in patients with non‐muscle invasive bladder cancer (NMIBC) who are either unresponsive or naïve to Bacillus Calmette-Guérin (BCG) therapy. One presentation will share preliminary results showing anti-tumor activity and safety data, while the other will further discuss safety and efficacy findings from the trial. Additionally, an interactive poster session on the updated data, including results from patients reaching the 12-month evaluation, is scheduled for Saturday, April 26, 2025. This program underlines Protara’s ongoing commitment to advancing innovative treatments for bladder cancer patients.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- March 5, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutic provided a business update
AI Summary
Protara Therapeutics provided a business update outlining key milestones and progress across its development programs. The company reported positive six‐month data from its Phase 2 ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC). CEO Jesse Shefferman emphasized that TARA-002 has shown promise as both a stand-alone treatment and in combination with other therapies. The company expects to share initial data from 12-month evaluable patients in the ADVANCED-2 trial by mid-2025. Protara is also preparing to start its pivotal THRIVE-3 trial of IV Choline Chloride for patients reliant on parenteral support in the first half of 2025, while an interim update from its Phase 2 STARBORN-1 trial in pediatric lymphatic malformations is anticipated by the end of the first half of 2025.
Additionally, the company reported robust financials, with $170 million in cash and investments as of December 31, 2024, supporting operations into 2027.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- January 13, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. today highlighted recent updates and anticipated 2025 milestones.
AI Summary
Protara Therapeutics, Inc. recently shared updates on its upcoming milestones for 2025 while emphasizing its progress in developing new treatments for cancer and rare diseases. The company expects to report 12‐month data from its ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer by mid‑2025, following promising interim results from the six-month evaluable patients. In addition, a futility analysis for approximately 25 six‑month evaluable BCG-Unresponsive patients is anticipated by the end of 2025.
Protara also plans to initiate the pivotal THRIVE‑3 trial of IV Choline Chloride in the first half of next year, which aims to support patients on parenteral nutrition. Moreover, further data from the Phase 2 STARBORN‑1 trial of TARA‑002 in pediatric lymphatic malformations is expected by the end of the first half of 2025. The company’s recent successful financing has extended its operational runway into 2027.
Read Announcement - Drug:
- TARA-002
- Announced Date:
- December 5, 2024
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc announced results from its ongoing Phase 2 open-label ADVANCED-2 trial. The trial is assessing intravesical TARA-002, the Company's investigational cell-based therapy, in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- December 3, 2024
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, announced it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, December 5, 2024, to review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC).
AI Summary
Protara Therapeutics announced that it will host a live conference call and webcast at 8:30 a.m. ET on December 5, 2024. During the call, the company will review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of its cell-based therapy, TARA-002, which is being tested for non-muscle invasive bladder cancer (NMIBC). This trial includes patients who have either not responded to or have never received Bacillus Calmette-Guérin (BCG) therapy.
The latest study results will also be highlighted during a poster session at the 25th Annual Meeting of the Society of Urologic Oncology later that day. Interested viewers are invited to register on the company’s website to participate in the live call or access the webcast, with a replay available for a limited time after the event.
Read Announcement
Intravenous Choline Chloride FDA Regulatory Events
Intravenous Choline Chloride is a drug developed by Protara Therapeutics for the following indication: For Patients Receiving Parenteral Support.
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:
- Intravenous Choline Chloride
- Announced Date:
- January 7, 2026
- Indication:
- For Patients Receiving Parenteral Support
Announcement
Protara Therapeutics, Inc. announced that patient dosing is now underway in its Phase 3 registrational THRIVE-3 clinical trial evaluating intravenous (IV) Choline Chloride in patients receiving long-term parenteral support (PS).
AI Summary
Protara Therapeutics announced that patient dosing is now underway in its Phase 3 registrational THRIVE-3 clinical trial evaluating intravenous (IV) Choline Chloride in patients receiving long-term parenteral support (PS). IV Choline Chloride is an investigational phospholipid substrate replacement designed for people on parenteral nutrition who cannot meet their choline needs by oral or enteral routes. Beginning patient dosing is an important step toward collecting the safety and effectiveness data the company needs to support future regulatory submissions.
THRIVE-3 will assess whether IV Choline Chloride improves nutritional status and outcomes for this vulnerable group. As dosing continues, enrollment and data collection will progress to help determine the therapy’s potential benefit. Protara is a clinical-stage company advancing this program alongside other investigational treatments for rare diseases and cancer.
Read Announcement
THRIVE-1 FDA Regulatory Events
THRIVE-1 is a drug developed by Protara Therapeutics for the following indication: Evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS).
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:
- THRIVE-1
- Announced Date:
- March 19, 2025
- Indication:
- Evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS).
Announcement
Protara Therapeutics, Inc. announced that data from THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS), will be featured during an oral session at the American Society for Parenteral and Enteral Nutrition (ASPEN) 2025 Nutrition Science & Practice Conference, taking place March 22 through March 25, 2025 in Columbus, Ohio.
AI Summary
Protara Therapeutics, Inc. announced that data from its THRIVE-1 study will be featured during an oral session at the ASPEN 2025 Nutrition Science & Practice Conference in Columbus, Ohio, from March 22 to 25, 2025. The THRIVE-1 study is a prospective, observational trial that examined the prevalence of choline deficiency and liver injury in patients who depend on parenteral support for nutrition.
The study found that 78% of patients were choline deficient, and 63% of those deficient showed signs of liver dysfunction. These findings highlight a significant unmet need for choline supplementation in this vulnerable group. Protara is developing an intravenous (IV) Choline Chloride formulation to address this gap, providing an alternative route for choline delivery when oral or enteral feeding is not an option.
Read Announcement- Drug:
- THRIVE-1
- Announced Date:
- September 9, 2024
- Target Action Date:
- Q1 2025
- Estimated Target Date Range:
- January 1, 2025 - March 31, 2025
- Indication:
- Evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS).
Announcement
Protara Therapeutics, Inc announced that Company expects to dose first patient in pivotal PK trial for IV Choline Chloride in Q1 2025
AI Summary
Protara Therapeutics, Inc. announced that the company expects to dose the first patient in its pivotal pharmacokinetic trial for IV Choline Chloride in the first quarter of 2025. This investigational therapy is a phospholipid substrate replacement developed to help patients who depend on parenteral support. The upcoming trial is a significant step forward in Protara’s ongoing efforts to advance innovative treatments for serious conditions, aligning with its strategy to enhance therapeutic options. The clinical trial is designed to assess the drug’s metabolism and effectiveness, with the potential to provide a new treatment avenue for patients in need. Protara’s commitment to transforming patient care continues to be reflected in its robust research and development pipeline, and the company looks forward to sharing more insights as the trial progresses.
Read Announcement- Drug:
- THRIVE-1
- Announced Date:
- September 9, 2024
- Indication:
- Evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS).
Announcement
Protara Therapeutics, Inc. announced the results of THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS).
AI Summary
Protara Therapeutics, Inc. recently announced key results from its THRIVE-1 study—a prospective, observational project that assessed the prevalence of choline deficiency and liver injury among patients dependent on parenteral support. The study highlights that choline deficiency may be an underrecognized issue in this vulnerable population and underscores the potential link to liver injury, offering important insights for future treatment strategies.
The THRIVE-1 findings add to Protara’s robust pipeline, which also includes development of novel therapies such as TARA-002 for pediatric patients with lymphatic malformations. The company’s expanding research efforts aim to address unmet medical needs in rare diseases and complex conditions. Protara’s work reflects its commitment to improving patient outcomes by exploring innovative approaches to both therapeutic intervention and supportive care in medically challenging groups.
Read Announcement
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