Tvardi Therapeutics (TVRD) FDA Approvals

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 Timeline and 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.

Provided Update - January 8,2026

• Drug: TTI-101
• Announced Date: January 8, 2026
• Indication: In Idiopathic Pulmonary Fibrosis

Tvardi Therapeutics, Inc. provided further updates from its Phase 2 REVERT IPF clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF). Preliminary results were announced on October 13, 2025.

Tvardi updated its Phase 2 REVERT IPF trial of TTI-101; preliminary results were announced October 13, 2025. An additional analysis limited to patients on study drug for 12 weeks excluded four patients for low dosing, undetectable drug, or unrelated bronchitis, leaving 40 patients (16 TTI-101, 24 placebo). On high-resolution CT, TTI-101 patients showed a 9.4% decrease from baseline in fibrosis score at week 12, versus a 2.4% decrease for placebo.

TTI-101 also produced larger IL-6 reductions than placebo, especially in patients with higher baseline IL-6. At 12 weeks, 63% of TTI-101 patients had improved FVC versus 46% of placebo. Mean FVC change was −15 mL for TTI-101 versus −22 mL for REVERT placebo and similar to historical controls. Tvardi said these results suggest STAT3 inhibition may reduce fibrosis and inflammation and support further study.

Provided Update - October 13,2025

Phase 2

• Drug: TTI-101
• Announced Date: October 13, 2025
• Indication: In Idiopathic Pulmonary Fibrosis

Tvardi Therapeutics, Inc provided an update on preliminary data from the Phase 2 REVERT clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF).

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.

Enrollment Completion - May 27,2025

Phase 2

• Drug: TTI-101
• Announced Date: May 27, 2025
• Indication: In Idiopathic Pulmonary Fibrosis

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).

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.