ropeginterferon alfa-2b-njft
Trade name: Besremi
Recombinant proteinapprovedOrphan Drug FDA
Approved
Nov 12, 2021
Clinical trial activity
4 trials · 3 clinical orgs · 2 marketing orgs
Phase 1
0
Phase 2
4
Phase 3
2
Phase 4
0
Earliest trial started Sep 29, 2022 (NCT05482971)
Timeline
2010s
- Apr 2, 2012
Orphan Drug Designation
2020s
- Nov 12, 2021
PharmaEssentia Corp. — Earliest FDA Approval
- Nov 12, 2021
Pharmaessentia Corp — Marketing Organization
- Nov 12, 2021
PharmaEssentia Corp. — NDA Secondary Org
- Nov 12, 2021
PharmaEssentia Corp. — NDA Organization
- Jan 1, 2022
PharmaEssentia Corp. — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2022
PharmaEssentia Corp. — Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
Interferon alpha/beta receptor agonist
Approval history
- approvedNov 12, 2021
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06770842 | Phase 2 | Jan 31, 2025 | The University of Hong Kong |
| NCT06514807 | Phase 3 | Dec 4, 2023 | AOP Orphan Pharmaceuticals AG |
| NCT05481151 | Phase 3 | Oct 26, 2022 | PharmaEssentia Corp. |
| NCT05482971 | Phase 2 | Sep 29, 2022 | PharmaEssentia Corp. |
Showing 4 of 4 trials
Page 1 / 1
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| PharmaEssentia Corp. | For profit | 2 | 2 | 2 | 2022 |
| AOP Orphan Pharmaceuticals AG | For profit | 1 | 1 | 1 | 2023 |
| The University of Hong Kong | Academic/Hospital | 1 | 1 | 1 | 2025 |
3 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| PharmaEssentia Corp. | For profit | NDA2 | Nov 12, 2021 |
| PharmaEssentia Corp. | For profit | NDA | Nov 12, 2021 |
| Pharmaessentia Corp | For profit | MKTG | Nov 12, 2021 |