Galunisertib
As of the edition of 20 October 2026, Galunisertib is a small molecule: in active development; acts on TGFBR1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Active, 2022
- Kind
- Small molecule
- Registered trials
- 24, 1 stopped early
- Disease areas
- Cancer; Digestive system; Hormones; Blood and lymph; Bones, joints and muscles; Ear, nose and throat
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TGFBR1 | TGF-beta receptor type-1 | P36897 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 12 | 12 | 0 | 0 |
| Phase 2 | 11 | 6 | 4 | 1 |
| Phase 3 | 1 | 1 | 0 | 0 |
| All trials | 24 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Lead sponsor of trials | 2005 to now |