Nifedipine
As of the edition of 20 October 2026, Nifedipine is a small molecule: marketed, first approved in 1982 (US); acts on CACNA1C, CACNA1D and CACNA1F and 1 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Procardia
- First approved
- 1 January 1982 (US)
- Approvals on record
- 15 in 5 regions
- Holder of the most recent approval
- NEOPHARMED GENTILI (ITALIE); 5 holders in all
- Registered trials
- 88, 8 stopped early
- Disease areas
- Heart and blood vessels; Pregnancy and women's health; Urinary and reproductive; Lungs and airways; Digestive system; Hormones
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Nifedipine.
See the 4 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 | 20 | 10 | 5 | 1 |
| Phase 1 | 13 | 10 | 1 | 0 |
| Phase 2 | 11 | 7 | 0 | 2 |
| Phase 3 | 16 | 8 | 2 | 3 |
| Phase 4 | 28 | 17 | 2 | 2 |
| All trials | 88 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Later holder and Lead sponsor of trials | 1985 to now |
| Norwich Pharmaceuticals | Acquired holder | 2021 to now |
| Pfizer | Applicant |