This section highlights FDA-related milestones and regulatory updates for drugs developed by Theratechnologies (TH).
Over the past two years, Theratechnologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Ibalizumab, Sudocetaxel, Tesamorelin, Tesamorelin, and TH1902. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Ibalizumab - FDA Regulatory Timeline and Events
Ibalizumab is a drug developed by Theratechnologies for the following indication: In Heavily Treatment-Experienced People with HIV and Multidrug Resistance.
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:
- Ibalizumab
- Announced Date:
- March 12, 2025
- Indication:
- In Heavily Treatment-Experienced People with HIV and Multidrug Resistance
Announcement
Theratechnologies Inc. today presented data from a real-world, observational, registry study demonstrating the efficacy and safety of ibalizumab in reducing HIV RNA to undetectable levels in heavily treatment-experienced (HTE) patients with multidrug resistant HIV.
AI Summary
Theratechnologies Inc. presented promising data from a real-world, observational registry study that highlights the efficacy and safety of ibalizumab. In this study, heavily treatment‐experienced patients with multidrug resistant HIV experienced a reduction of HIV RNA to undetectable levels. The study’s outcomes support the use of ibalizumab as an effective treatment option for patients who have exhausted other therapies, demonstrating both significant antiviral benefit and an acceptable safety profile.
This new evidence is important because it provides real-world confirmation of ibalizumab’s role in managing complicated HIV cases. It underscores the need for innovative treatment approaches in patients facing multidrug resistance while addressing an urgent clinical need. Theratechnologies’ commitment to advancing HIV care is reflected in this data, which may help guide future treatment strategies and improve outcomes for a challenging patient population.
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Sudocetaxel Zendusortide - FDA Regulatory Timeline and Events
Sudocetaxel Zendusortide is a drug developed by Theratechnologies for the following indication: for the treatment of cancer derived from its SORT1+ Technology™.
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:
- Sudocetaxel Zendusortide
- Announced Date:
- May 23, 2024
- Indication:
- for the treatment of cancer derived from its SORT1+ Technology™.
Announcement
Theratechnologies Inc announced Phase 1 data demonstrating signs of long-term efficacy and a manageable safety profile of its lead investigational peptide drug conjugate (PDC) candidate, sudocetaxel zendusortide (TH1902), in patients with solid tumors.
AI Summary
Theratechnologies Inc announced promising Phase 1 trial data for its investigational peptide drug conjugate, sudocetaxel zendusortide (TH1902), in patients with solid tumors. The updated analysis from Parts 1 and 2 of the ongoing study showed signs of long-term efficacy, with durable disease stabilization lasting up to 45 weeks beyond treatment completion. These results suggest that TH1902 works through a unique, multimodal mechanism of action, which includes triggering immune responses and targeting chemotherapy-resistant cancer stem cells.
The safety profile of sudocetaxel zendusortide was found to be manageable at a 300mg/m2 dose, with few Grade 3 adverse events reported. Early efficacy signals were notably observed in female cancers, such as ovarian, endometrial, and triple-negative breast cancer. This encouraging data supports advancing to Part 3 of the Phase 1 trial focused on dose optimization.
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Tesamorelin - FDA Regulatory Timeline and Events
Tesamorelin is a drug developed by Theratechnologies for the following indication: For the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.
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:
- Tesamorelin
- Announced Date:
- April 8, 2025
- Indication:
- For the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.
Announcement
Theratechnologies Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Prior Approval Supplement (PAS) to the supplemental biologics license application (sBLA) for EGRIFTA SV® (tesamorelin for injection).
AI Summary
Theratechnologies Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Prior Approval Supplement (PAS) to the supplemental biologics license application (sBLA) for EGRIFTA SV® (tesamorelin for injection). This approval removes the need for discretionary product release, allowing the company to resume regular distribution of EGRIFTA SV®. The treatment is currently the only FDA-approved option to reduce excess abdominal fat in HIV-infected adult patients with lipodystrophy. With this regulatory milestone, Theratechnologies can now close a period of supply uncertainty, ensuring that all manufactured batches meet standard release requirements. The company’s announcement highlights a renewed focus on providing consistent access to the therapy, which plays a vital role for patients who rely on it. The move is expected to improve the overall patient experience, paving the way for a smoother transition to the upcoming improved formulation.
Read Announcement- Drug:
- Tesamorelin
- Announced Date:
- February 13, 2025
- Indication:
- For the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.
Announcement
Theratechnologies Inc. announced that it has resumed distribution of EGRIFTA SV® (tesamorelin for injection), following correspondence from the U.S. Food and Drug Administration (FDA) that allows the Company to release two recently manufactured batches of EGRIFTA SV®.
AI Summary
Theratechnologies Inc. recently announced that it has resumed the distribution of EGRIFTA SV® (tesamorelin for injection) after receiving favorable correspondence from the U.S. Food and Drug Administration (FDA). The FDA’s communication permits the company to release two newly manufactured batches of the drug, which are now ready for immediate shipment to network pharmacies. This step is part of the company’s ongoing commitment to provide crucial treatment to people with HIV in the United States.
The decision to restart distribution comes as part of efforts to ensure reliable access to EGRIFTA SV® for patients who depend on it. The company expressed appreciation for the FDA’s collaboration and looks forward to continuing its mission of delivering innovative therapies that redefine standards of care.
Read Announcement- Drug:
- Tesamorelin
- Announced Date:
- October 9, 2024
- Indication:
- For the reduction of excess abdominal fat in adults with HIV who have lipodystrophy.
Announcement
Theratechnologies Inc announced three upcoming poster presentations at IDWeek 2024, taking place October 16-19 in Los Angeles, Calif.
AI Summary
Theratechnologies Inc. announced that it will present three research posters at IDWeek 2024, held in Los Angeles, California from October 16-19. The posters focus on important health issues faced by people with HIV. One poster highlights data linking excess visceral abdominal fat (EVAF) to a higher risk of cardiovascular disease. Another poster shows that tesamorelin—a growth hormone-releasing factor analog—can reduce EVAF and lower cardiovascular risk in HIV patients. A third poster details the study design and baseline characteristics of the PROMISE-US trial, which investigates ibalizumab in heavily treatment-experienced patients with multidrug-resistant HIV.
These presentations aim to provide new insights for clinicians and researchers into managing complications associated with long-term HIV treatment. The findings will be shared during scheduled sessions at IDWeek 2024, marking an important opportunity for advancing understanding of HIV-related health issues.
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Tesamorelin F8 - FDA Regulatory Timeline and Events
Tesamorelin F8 is a drug developed by Theratechnologies for the following indication: to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy.
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:
- Tesamorelin F8
- Announced Date:
- March 25, 2025
- Indication:
- to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy
Announcement
Theratechnologies Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection.
AI Summary
Theratechnologies Inc. received FDA approval for its supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin for injection, which will be marketed under the name EGRIFTA WR™. This new formulation is designed to replace the current EGRIFTA SV® product. EGRIFTA WR™ offers greater convenience by requiring reconstitution only once a week, instead of daily, and uses less than half the injection volume compared to its predecessor. It has been shown to be bioequivalent to earlier formulations of tesamorelin. The product is approved for reducing excess abdominal fat in HIV-infected adults with lipodystrophy. With this FDA approval, Theratechnologies aims to provide patients with a more user-friendly treatment option that may help improve adherence and overall management of lipodystrophy, thereby enhancing the patient experience and quality of life.
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TH1902 - FDA Regulatory Timeline and Events
TH1902 is a drug developed by Theratechnologies for the following indication: Sortilin Positive 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:
- TH1902
- Announced Date:
- December 9, 2024
- Indication:
- Sortilin Positive Solid Tumors
Announcement
Theratechnologies Inc announced data from Part 3 (dose optimization, weekly dosing schedule) of its ongoing Phase 1b trial of sudocetaxel zendusortide (TH1902) – the company's lead investigational peptide drug conjugate (PDC) – in patients with advanced ovarian cancer.
AI Summary
Theratechnologies Inc. announced promising data from Part 3 of its ongoing Phase 1b trial in patients with advanced ovarian cancer. This part of the study focused on dose optimization using a weekly dosing schedule for sudocetaxel zendusortide (TH1902), the company's lead investigational peptide drug conjugate (PDC). Patients were divided into two groups, with Arm A receiving 1.75 mg/kg/week and Arm B receiving 2.5 mg/kg/week.
The trial reported no dose-limiting toxicities in either group. Notably, in Arm B, several patients showed encouraging signs of activity including significant tumor shrinkage, marked decreases in the CA-125 ovarian tumor marker, and one patient even achieved complete resolution of a liver lesion. These results support the further investigation of higher doses in this challenging patient population.
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