Drugs / Ropeginterferon alfa-2b
Ropeginterferon alfa-2b
also known as
P1101 · BESREMi · Pegylated-Proline-interferon alpha-2b · ropeg · AOP2014 · Ropeginterferon alfa-2b-njft
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BESREMI | — | 2021-11-12 | fda.gov ↗ |
| Approved | EU (EMA) | Besremi | — | 2019-02-15 | europa.eu ↗ |
Trials 38 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT07521046 | Aug 2026 → Aug 2029 expected | myelofibrosis | University of Utah | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07047885 | Aug 2025 → Jun 2028 expected | primary cutaneous T-cell lymphoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT07053904 | Apr 2025 → Dec 2028 expected | cancer | PharmaEssentia | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT04638439 | Aug 2022 → Apr 2026 | chronic hepatitis B virus infection, hepatitis D virus infection | PharmaEssentia | Completed | No outcome recorded |
| Phase 1 | NCT04774107 | Nov 2020 → Jul 2022 | chronic hepatitis C virus infection | PharmaEssentia | Completed | No outcome recorded |
| Phase 1 | NCT03546465 | May 2018 → Jul 2019 | — | PharmaEssentia Japan K.K. | Completed | No outcome recorded |
| Phase 1 | NCT01933906 | Aug 2013 → Nov 2018 | chronic myeloid leukemia | Study Group of Medical Tumour Therapy (AGMT) | Completed | No outcome recorded |
| Phase 1 | NCT05129644 | Nov 2009 → Jun 2010 | — | PharmaEssentia | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07646821 | Nov 2026 → Dec 2028 expected | myeloid hemopathy | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT04233840 | Feb 2019 → Dec 2022 | hepatocellular carcinoma | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT01193699 | Aug 2010 → Jan 2018 | acquired polycythemia vera | AOP Orphan Pharmaceuticals AG | Completed | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT07269470 | Nov 2026 → Nov 2029 expected | chronic myeloid leukemia | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07468916 | Sep 2026 → Sep 2031 expected | atypical chronic myeloid leukemia, BCR-ABL1 negative, chronic myelomonocytic leukemia | Jonsson Comprehensive Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06770842 | Mar 2025 → Dec 2026 expected | myelofibrosis with myeloid metaplasia | The University of Hong Kong | Recruiting | No outcome recorded |
| Phase 2 | NCT05467553 | Feb 2023 → Feb 2025 | hepatitis D virus infection | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05731245 | Feb 2023 → Oct 2024 overdue | primary myelofibrosis | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05482971 | Sep 2022 → May 2025 overdue | essential thrombocythemia | PharmaEssentia | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05485948 | Oct 2021 → Sep 2022 overdue | acquired polycythemia vera | PharmaEssentia | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04988815 | Sep 2021 → Jul 2025 | myelofibrosis, primary myelofibrosis | The University of Hong Kong | Unknown | No outcome recorded |
| Phase 2 | NCT04182100 | Dec 2019 → Mar 2021 | acquired polycythemia vera | PharmaEssentia Japan K.K. | Completed | No outcome recorded |
| Phase 2 | NCT03003325 | Feb 2017 → Mar 2022 | acquired polycythemia vera | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS | Completed | No outcome recorded |
| Phase 2 | NCT02370329 | Aug 2015 → Nov 2023 | myelofibrosis, primary myelofibrosis | Mayo Clinic | Terminated | No outcome recorded |
| Phase 2 | NCT01587586 | Oct 2011 → Nov 2016 | chronic hepatitis C virus infection | PharmaEssentia | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05808322 | May 2023 → May 2024 | COVID-19 | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT07623200 | Jul 2026 → Jun 2029 expected | essential thrombocythemia | Incyte Corporation | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06468033 | Jul 2025 → Sep 2027 expected | primary myelofibrosis | PharmaEssentia | Recruiting | No outcome recorded |
| Phase 3 | NCT06514807 | Dec 2023 → Mar 2028 expected | essential thrombocythemia | AOP Orphan Pharmaceuticals AG | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06002490 | Oct 2023 → Jul 2024 | acquired polycythemia vera | PharmaEssentia Japan K.K. | Completed | No outcome recorded |
| Phase 3 | NCT05481151 | Oct 2022 → Jun 2025 overdue | acquired polycythemia vera | PharmaEssentia | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05770466 | Apr → Dec 2022 | COVID-19 | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT04655092 | Jan 2021 → Jun 2026 overdue | acquired polycythemia vera | PharmaEssentia Japan K.K. | Recruiting | No outcome recorded |
| Phase 3 | NCT04285086 | Aug 2020 → Nov 2024 overdue | essential thrombocythemia | PharmaEssentia | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03117816 | May 2017 → Jan 2022 | chronic myeloid leukemia | Philipps University Marburg | Completed | No outcome recorded |
| Phase 3 | NCT04382937 | Jan 2016 → Jul 2020 | chronic hepatitis C virus infection | PharmaEssentia | Completed | No outcome recorded |
| Phase 3 | NCT02523638 | Jul → Dec 2015 | acquired polycythemia vera | AOP Orphan Pharmaceuticals AG | Completed | No outcome recorded |
| Phase 3 | NCT02218047 | Nov 2014 → Apr 2021 | acquired polycythemia vera | AOP Orphan Pharmaceuticals AG | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06290765 | Feb → Dec 2026 expected | acquired polycythemia vera | PharmaEssentia | Not yet recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05494528 | May 2021 → Dec 2023 | chronic hepatitis B virus infection | National Taiwan University Hospital | Unknown | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ropeginterferon alfa-2b | “P1101 (Ropeginterferon alfa-2b) 450 µg subcutaneously (SC) Q2W for 6 doses (12 weeks), followed by 0.3 mg/kg Nivolumab for 6 doses (12 weeks), with a follow up of 24 weeks. All...” NCT04638439 ↗24“Ropeginterferon alfa-2b (P1101) is a novel long-acting mono-PEGylated recombinant proline interferon (IFN)” PMID 34386602 ↗ Jul 2021 “used a next-generation, mono-pegylated interferon (IFN) α-2b isoform, ropeginterferon alfa-2b.” PMID 26261238 ↗ Aug 2015 “Name: P1101 (Ropeginterferon alfa-2b)” NCT05770466 ↗ “P1101 (Ropeginterferon alfa-2b)” NCT04655092 ↗ “P1101 (Ropeginterferon alfa-2b)” NCT04233840 ↗ “• Ropeginterferon alfa-2b” NCT07623200 ↗ |
| Known as | AOP2014 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03003325 ↗ |
| Known as | BESREMi | “Ropeginterferon alfa-2b (tradename BESREMi®) 250 micrograms/0.5 mL or 500 micrograms/0.5 ml solution for injection in pre-filled pen.” NCT06514807 ↗2“Ropeginterferon Alfa-2B Prefilled Syringe [Besremi]” NCT05731245 ↗ “Ropeginterferon alfa-2b (BESREMi®)” NCT06770842 ↗ |
| Known as | P1101 | “Ropeginterferon alfa-2b-njft (P1101), which gained US marketing authorization in November 2021, is the only interferon alfa approved for the treatment of PV.” NCT05481151 ↗13“Ropeginterferon alfa-2b (P1101) is a novel long-acting mono-PEGylated recombinant proline interferon (IFN)” PMID 34386602 ↗ Jul 2021 “Ropeginterferon alfa-2b (P1101)” NCT07269470 ↗ |
| Known as | Pegylated-Proline-interferon alpha-2b | “AOP2014 / Pegylated-Proline-interferon alpha-2b” NCT03117816 ↗ |
| Known as | ropeg | “BACKGROUND: Ropeginterferon alfa-2b-njft (ropeg), a mono-PEGylated interferon-α, showed efficacy and safety in patients with hydroxyurea-intolerant/resistant essential...” PMID 42306077 ↗ Jun 20262“Ropeginterferon alfa-2b (ropeg) is a next-generation monopegylated interferon alfa-2b developed specifically to treat myeloproliferative neoplasms.” PMID 41875235 ↗ Jun 2026 “Ropeginterferon alfa-2b (ropeg) represents a new-generation interferon-based therapy approved for polycythaemia vera (PV) treatment.” PMID 40313042 ↗ Jun 2025 |
| Known as | Ropeginterferon alfa-2b-njft | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05482971 ↗ |
| Action | Inhibit | “inhibition of virus replication in virus infected cells” NCT05770466 ↗ |
| Modality | Protein / enzyme biologic | “a next-generation, mono-pegylated interferon (IFN) α-2b isoform” PMID 26261238 ↗ Aug 2015 |
| Route | Subcutaneous | “subcutaneously, 2-weekly administration” NCT01193699 ↗ |