Drotaverine
As of the edition of 20 October 2026, Drotaverine is a small molecule: marketed; acts on PDE4A, PDE4B and PDE4C and 1 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed
- Kind
- Small molecule
- Brand name
- Algoflex-M
- Approvals on record
- 10 in 10 regions
- Holder of the most recent approval
- Opella Healthcare France Sas; 6 holders in all
- Registered trials
- 3, 1 stopped early
- Disease areas
- Digestive system
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 2 | 1 | 0 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 3 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Sanofi | Lead sponsor of trials | 2005 to now |