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-109 and TTI-101. 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.
TTI-109 FDA Regulatory Timeline and Events
TTI-109 is a drug developed by Tvardi Therapeutics for the following indication: Pharmacodynamic Evidence of STAT3 Target Engagement.
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-109
- Announced Date:
- August 12, 2026
- Indication:
- Pharmacodynamic Evidence of STAT3 Target Engagement
Announcement
Tvardi Therapeutics, Inc. announced that it will host a KOL webinar on Wednesday, August 19, 2026 at 11:00 AM ET featuring Randy Longman, MD, PhD (Weill Cornell Medicine), who will join Tvardi management to discuss the current treatment landscape in ulcerative colitis (UC) and the persistent unmet needs that remain despite recent clinical advances and currently approved therapies.
Read Announcement- Drug:
- TTI-109
- Announced Date:
- July 30, 2026
- Indication:
- Pharmacodynamic Evidence of STAT3 Target Engagement
Announcement
Tvardi Therapeutics, Inc. announced that it has selected ulcerative colitis (UC) as the initial disease indication for its next generation STAT3 inhibitor, TTI-109.
AI Summary
Tvardi Therapeutics has selected ulcerative colitis (UC) as the first disease indication for TTI-109, its next-generation STAT3 inhibitor. STAT3 is a key signaling hub that connects several processes involved in UC, including abnormal immune responses, ongoing inflammation and tissue changes that can lead to fibrosis. Unlike many approved treatments that target a single pathway, TTI-109 is designed to act where multiple pathways meet. This approach may help address the needs of patients who do not achieve remission with current therapies.
The decision follows a Phase 1 study in healthy volunteers, which showed that TTI-109 reduced several immune cell populations linked to UC, including Th17, T follicular helper and B cells. Tvardi plans to begin a study in patients with moderate-to-severe UC in 2027, pending regulatory clearance and funding. The trial will primarily assess safety and will also examine remission, biomarkers and genetic factors.
Read Announcement- Drug:
- TTI-109
- Announced Date:
- July 7, 2026
- Indication:
- Pharmacodynamic Evidence of STAT3 Target Engagement
Announcement
Tvardi Therapeutics, Inc announced Phase 1 results for TTI-109, its next-generation STAT3 inhibitor.
AI Summary
Tvardi Therapeutics said its Phase 1 results for TTI-109, a next-generation STAT3 inhibitor, were positive. The drug showed exposure similar to TTI-101 while being better tolerated. Tvardi also reported meaningful drops in disease-related immune cells linked to STAT3 activity, including Th17 cells, T follicular helper cells, and B cells.
The study’s main goals were to show that TTI-109 quickly converts to TTI-101, reaches equal exposure at matching molar doses, and increases exposure as the dose rises. Safety and tolerability were also compared with TTI-101 and placebo, while immune effects were explored as an extra measure.
Tvardi plans to move TTI-109 into dermatologic and gastrointestinal diseases driven by STAT3, but those next steps depend on funding and regulatory clearance. The company said it will discuss the results in an investor webcast.
Read Announcement- Drug:
- TTI-109
- Announced Date:
- July 7, 2026
- Indication:
- Pharmacodynamic Evidence of STAT3 Target Engagement
Announcement
Tvardi Therapeutics, Inc announced Phase 1 results for TTI-109, its next-generation STAT3 inhibitor.
AI Summary
Tvardi Therapeutics said its Phase 1 results for TTI-109, a next-generation STAT3 inhibitor, were promising. The study showed that TTI-109 produced exposure similar to TTI-101, but with better tolerability. It also lowered key disease-related immune cell groups linked to STAT3 activity, including Th17 cells, T follicular helper cells, and B cells.
The main goal of the trial was to confirm that TTI-109 quickly converts to TTI-101 and reaches similar levels in the body at matching doses. Researchers also looked at safety, tolerability, and dose response. Tvardi said these early findings support further development of TTI-109 in dermatologic and gastrointestinal diseases driven by STAT3, although future progress depends on more funding and regulatory clearance.
Read Announcement
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.
- Drug:
- TTI-101
- Announced Date:
- January 8, 2026
- Indication:
- In Idiopathic Pulmonary Fibrosis
Announcement
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.
AI Summary
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.
Read Announcement- 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
