Carnitine
As of the edition of 20 October 2026, Carnitine is a small molecule: marketed, first approved in 1969 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1969
- Kind
- Small molecule
- Brand name
- Pranzo
- First approved
- 1 May 1969 (ES)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Laboratorios Vinas S.A.
- Registered trials
- 58, 8 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Nutrition and metabolism; Nervous system; Hormones; Heart and blood vessels
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 7 | 1 | 0 |
| Phase 1 | 5 | 1 | 0 | 2 |
| Phase 2 | 18 | 9 | 4 | 1 |
| Phase 3 | 14 | 6 | 1 | 3 |
| Phase 4 | 11 | 5 | 1 | 2 |
| All trials | 58 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Iperboreal Pharma | Lead sponsor of trials | 2004 to now |
| Bausch Health | Lead sponsor of trials | 2018 to now |
| IlDong Pharmaceutical | Lead sponsor of trials | 2018 to now |
| Biolab Sanus Farmaceutica | Lead sponsor of trials |