Betaine
As of the edition of 20 October 2026, Betaine is a small molecule: marketed, first approved in 1990 (FR); acts on BHMT and BHMT2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Cystadane
- First approved
- 22 August 1990 (FR)
- Approvals on record
- 5 in 5 regions
- Holder of the most recent approval
- ReqMed Company, Ltd.; 3 holders in all
- Registered trials
- 24, 1 stopped early
- Disease areas
- Nutrition and metabolism; Digestive system; Inherited and neonatal; Nervous system; Urinary and reproductive; 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.
Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Betaine.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 8 | 3 | 0 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 5 | 2 | 3 | 0 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 24 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Recordati Rare Diseases | Acquired holder | 2022 to now |