Tvardi Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Tvardi Therapeutics (TVRD).
Over the past two years, Tvardi Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TTI-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TTI-101 FDA Regulatory Events
TTI-101 is a drug developed by Tvardi Therapeutics for the following indication: In 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:
- TTI-101
- Announced Date:
- October 13, 2025
- Indication:
- In Idiopathic Pulmonary Fibrosis
Announcement
Tvardi Therapeutics, Inc provided an update on preliminary data from the Phase 2 REVERT clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF).
AI Summary
Tvardi Therapeutics provided an update on preliminary data from its Phase 2 REVERT trial of TTI-101 in idiopathic pulmonary fibrosis (IPF). The randomized, double-blind study compared 400 mg and 800 mg daily doses versus placebo, with or without nintedanib.
Of 88 patients, discontinuations were higher in the TTI-101 arms (56.7% at 400 mg, 62.1% at 800 mg) versus placebo (10.3%), mainly due to gastrointestinal side effects, especially when combined with nintedanib. Baseline lung function was similar across treated groups but slightly lower in the placebo arm.
Exploratory analysis of Forced Vital Capacity (FVC) showed no significant differences between groups: 41% of placebo patients and 39–44% of treated patients improved from baseline. FVC changes overlapped across arms, and the placebo group’s decline was lower than expected. Tvardi concluded the trial did not meet its goals and will conduct further analyses before deciding next steps.
Read Announcement- Drug:
- TTI-101
- Announced Date:
- May 27, 2025
- Indication:
- In Idiopathic Pulmonary Fibrosis
Announcement
Tvardi Therapeutics, Inc announced that it has completed enrollment for its lead program in a Phase 2 clinical trial of TTI-101 for patients with idiopathic pulmonary fibrosis (IPF).
AI Summary
Tvardi Therapeutics, Inc. announced a major milestone by completing enrollment for its lead program in a Phase 2 clinical trial, REVERT IPF, which is testing TTI-101 for patients with idiopathic pulmonary fibrosis (IPF). TTI-101 is an oral small molecule that targets STAT3, a key player in the fibrotic signaling pathways that contribute to the progression of IPF—a chronic, debilitating lung disease with a high unmet need for effective treatments.
The REVERT IPF trial is randomized, double-blind, and placebo-controlled, focusing on assessing both safety and lung function improvements through measurements such as forced vital capacity (FVC). Tvardi’s CEO highlighted the trial’s potential, noting that TTI-101’s dual action could reduce lung fibrosis and restore lung function. Topline data from the trial are anticipated in the fourth quarter of 2025.
Read Announcement
Tvardi Therapeutics FDA Events - Frequently Asked Questions
As of now, Tvardi Therapeutics (TVRD) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Tvardi Therapeutics (TVRD) has reported FDA regulatory activity for TTI-101.
The most recent FDA-related event for Tvardi Therapeutics occurred on October 13, 2025, involving TTI-101. The update was categorized as "Provided Update," with the company reporting: "Tvardi Therapeutics, Inc provided an update on preliminary data from the Phase 2 REVERT clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF)."
Currently, Tvardi Therapeutics has one therapy (TTI-101) targeting the following condition: In Idiopathic Pulmonary Fibrosis.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:TVRD) was last updated on 10/24/2025 by MarketBeat.com Staff
