Tolbutamide
As of the edition of 20 October 2026, Tolbutamide is a small molecule: marketed, first approved in 1975 (CA); acts on ABCC8 and KCNJ11.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Orinase
- First approved
- 31 December 1975 (CA)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Sandoz; 3 holders in all
- Registered trials
- 17, 2 stopped early
- Disease areas
- Cancer; Blood and lymph; Bones, joints and muscles; Digestive system; Immune system; Infections
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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 15 | 13 | 0 | 2 |
| All trials | 17 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sandoz | Acquired holder | 2005 to now |
| Pfizer | Applicant and Lead sponsor of trials | 2018 to now |
| Vitarine Pharmaceuticals | Later holder |