resmetirom
Trade name: REZDIFFRA
Small moleculeapprovedFast Track FDABreakthrough Therapy FDA
Approved
Mar 14, 2024
Clinical trial activity
7 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
4
Phase 3
3
Phase 4
1
Earliest trial started Dec 31, 2019 (NCT04197479)
Timeline
2010s
- Jan 1, 2019
Madrigal Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
2020s
- Jan 1, 2024
Madrigal Pharmaceuticals — Earliest Phase 1 Sponsor(trial)
- Mar 14, 2024
Madrigal Pharmaceuticals — Earliest FDA Approval
- Mar 14, 2024
Madrigal Pharmaceuticals — NDA Organization
- Jan 1, 2026
Earliest Phase 2 Sponsor(trial)
Indications
Mechanism of action
THRB agonist
Approval history
- approvedPriority reviewAcceleratedFast trackBreakthroughMar 14, 2024
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07143968 | Phase 2 | Jan 31, 2026 | Indiana University |
| NCT07249788 | Phase 4 | Nov 30, 2025 | Nabiqasim Industries (Pvt) Ltd |
| NCT07216313 | Phase 1 | Sep 30, 2025 | Sagimet Biosciences Inc. |
| NCT06397872 | Phase 1 | Mar 5, 2024 | Madrigal Pharmaceuticals |
| NCT05500222 | Phase 3 | Aug 26, 2022 | Madrigal Pharmaceuticals |
| NCT04951219 | Phase 3 | Jul 9, 2021 | Madrigal Pharmaceuticals |
| NCT04197479 | Phase 3 | Dec 31, 2019 | Madrigal Pharmaceuticals |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Madrigal Pharmaceuticals | For profit | 4 | 4 | 2 | 2019 |
| Indiana University | Academic/Hospital | 1 | 1 | 1 | 2026 |
| Nabiqasim Industries (Pvt) Ltd | For profit | 1 | 1 | 1 | 2025 |
| Sagimet Biosciences Inc. | For profit | 1 | 1 | 1 | 2025 |
4 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Madrigal Pharmaceuticals | For profit | NDA | Mar 14, 2024 |