Peginterferon alfa-2b
As of the edition of 20 October 2026, Peginterferon alfa-2b is a protein: marketed, first approved in 2001 (US); acts on IFNAR1 and IFNAR2; US protection ended in 2013.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2001
- Kind
- Protein
- Brand name
- Pegintron
- First approved
- 19 January 2001 (US)
- Approvals on record
- 16 in 2 regions
- Holder of the most recent approval
- Merck & Co.
- Withdrawn from market
- 21 April 2021 (in some regions)
- Registered trials
- 223, 53 stopped early
- Disease areas
- Infections; Digestive system; Cancer; Urinary and reproductive; Immune system; Blood and lymph
US protection
US protection ended in 2013.
US protection ended in 2013, 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 Merck & Co.. 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 product2 listings count towards this date. The exact date and each listing are in the product.
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Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 49 | 35 | 2 | 8 |
| Phase 1 | 20 | 11 | 1 | 7 |
| Phase 2 | 63 | 40 | 2 | 15 |
| Phase 3 | 68 | 50 | 0 | 15 |
| Phase 4 | 23 | 10 | 2 | 8 |
| All trials | 223 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 1997 to now |