Levosimendan
As of the edition of 20 October 2026, Levosimendan is a small molecule: marketed, first approved in 2001 (ES); acts on PDE3A, PDE3B and TNNC1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Simdax
- First approved
- 3 August 2001 (ES)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- BIOLAB SANUS FARMACĂUTICA LTDA; 2 holders in all
- Registered trials
- 64, 7 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Infections; Nutrition and metabolism; Injuries; Lungs and airways
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 | 15 | 7 | 1 | 0 |
| Phase 2 | 12 | 10 | 0 | 1 |
| Phase 3 | 22 | 6 | 2 | 4 |
| Phase 4 | 15 | 6 | 0 | 2 |
| All trials | 64 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Orion Pharma | Applicant | 2013 to now |