Becaplermin
As of the edition of 20 October 2026, Becaplermin is a protein: marketed, first approved in 1997 (US); acts on PDGFRA and PDGFRB; US protection ended in 2009.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Protein
- Brand name
- Regranex
- First approved
- 16 December 1997 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Lynch Regenerative Medicine
- Withdrawn from market
- 16 July 2012 (in some regions)
- Registered trials
- 11, 2 stopped early
- Disease areas
- Hormones; Heart and blood vessels; Skin and connective tissue; Nervous system; Nutrition and metabolism; Cancer
US protection
US protection ended in 2009.
US protection ended in 2009, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Lynch Regenerative Medicine. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
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 Becaplermin.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 0 |
| Phase 2 | 5 | 3 | 0 | 1 |
| Phase 3 | 3 | 1 | 0 | 1 |
| All trials | 11 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Smith & Nephew | Earlier holder | 1997 to now |
| Lynch Regenerative Medicine | Acquired holder | 2026 to now |