Drugs / Ropeginterferon alfa-2b
Ropeginterferon alfa-2b
also known as
P1101 · BESREMi · ropeg · AOP2014 · Ropeginterferon alfa-2b-njft · Pegylated-Proline-interferon alpha-2b
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acquired polycythemia vera 2 milestones | |||||
| Filed | Other | BESREMi | acquired polycythemia vera | 2025-07-18 | “The Company Announces Filing of New Drug Submission of BESREMi (Ropeginterferon alfa-2b) for PV in Canada” pharmaessentia.com ↗ |
| Filed | Other | BESREMi | acquired polycythemia vera | 2025-04-01 | “The Company Announces Submission of Marketing Authorization Application of BESREMi (Ropeginterferon alfa-2b) for PV in Vietnam” pharmaessentia.com ↗ |
| Filed essential thrombocythemia 4 milestones | |||||
| Filed | US (FDA) | BESREMi | essential thrombocythemia | 2025-11-25 | “The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted a sBLA with the U.S. FDA.” pharmaessentia.com ↗ “The Company is seeking a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted a sBLA with the U.S. FDA.” pharmaessentia.com ↗ |
| Filed | Japan (PMDA) | BESREMi | essential thrombocythemia | 2025-09-18 | “Filing for an Additional Indication of BESREMi (Ropeginterferon alfa-2b) for ET in Japan” pharmaessentia.com ↗ |
| Filed | Other | BESREMi | essential thrombocythemia | 2025-09-05 | “PharmaEssentia Files for an Additional Indication of Besremi (Ropeginterferon alfa-2b) for the Treatment of Essential Thrombocythemia (ET) with TFDA” pharmaessentia.com ↗ |
| Filed | China (NMPA) | — | essential thrombocythemia | 2025-06-30 | “The Company Announces Submission of Marketing Authorization Application of Ropeginterferon alfa-2b (P1101) for ET in China” pharmaessentia.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | BESREMI | — | 2021-11-12 | fda.gov ↗ |
| Approved | EU (EMA) | Besremi | — | 2019-02-15 | europa.eu ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials · 1 met primary | ||||||
| Phase 1 | NCT07521046 | Oct 2026 → Aug 2029 expected | myelofibrosis | University of Utah | 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 | Met primary |
| 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 · 1 met primary | ||||||
| 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 | NCT07269470 | Jul 2026 → Nov 2029 expected | chronic myeloid leukemia | M.D. Anderson Cancer Center | 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 | Met primary |
| 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 310 trials · 1 met primary | ||||||
| Phase 3 | NCT07623200 | Sep 2026 → Jun 2029 expected | essential thrombocythemia | Incyte Corporation | 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 | Met primary |
| 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 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT07722611 Comparator | Oct 2026 → Jun 2032 expected | acquired polycythemia vera | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-05-22 | PharmaEssentia | Results PharmaEssentia to Present New Clinical Data Supporting the Use of Ropeginterferon Alfa-2b in Essential Thrombocythemia at ASCO and EHA 2026 pharmaessentia.com ↗
Two-year and post-hoc SURPASS-ET analyses highlight the impact of treatment timing, with durable responses and improved progression-free survival supporting consideration of earlier ropeginterferon alfa-2b use in high-risk ET following hydroxyurea intolerance or resistance |
| 2026-03-02 | PharmaEssentia | Regulatory PharmaEssentia Announces Japan Approval of High-Dose Dosing Regimen for BESREMi® pharmaessentia.com ↗ |
| 2026-01-13 | PharmaEssentia | Regulatory FDA Confirms a PDUFA Goal Date of August 30, 2026 for the sBLA Submission of Ropeginterferon Alfa-2b-njft in Essential Thrombocythemia (ET) pharmaessentia.com ↗
The FDA has completed its filing review of the Company’s sBLA and determined that the submission is sufficiently complete to proceed with a substantive review. |
| 2026-01-12 | PharmaEssentia | Results PharmaEssentia Announces Positive Topline Phase 2b Data from EXCEED-ET Study Evaluating Ropeginterferon Alfa-2b-njft for Essential Thrombocythemia pharmaessentia.com ↗
PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced positive topline results from its Phase 2b EXCEED-ET clinical trial of ropeginterferon alfa-2b-njft in patients with essential thrombocythemia (ET). |
| 2025-11-25 | PharmaEssentia | Results PharmaEssentia Announces Publication of Phase 3 SURPASS-ET Results in The Lancet Haematology pharmaessentia.com ↗
Ropeginterferon alfa-2b Demonstrated Superior Efficacy and Favorable Safety Compared with Anagrelide in Hydroxyurea-Resistant or -Intolerant Essential Thrombocythemia with Leukocytosis |
| 2025-10-06 | PharmaEssentia | Regulatory Material Information - Hong Kong Department of Health has Approved the New Drug Registration of BESREMi (Ropeginterferon alfa-2b) for PV pharmaessentia.com ↗
Hong Kong Department of Health has Approved the New Drug Registration of BESREMi (Ropeginterferon alfa-2b) for PV |
| 2025-09-18 | PharmaEssentia | Regulatory Material Information - Announcement on Behalf of PharmaEssentia Japan KK: Filing for an Additional Indication of BESREMi (Ropeginterferon alfa-2b) for ET in Japan pharmaessentia.com ↗
Filing for an Additional Indication of BESREMi (Ropeginterferon alfa-2b) for ET in Japan |
| 2025-09-11 | PharmaEssentia | Regulatory Material Information - The Health Canada has Accepted the New Drug Submission of Ropeginterferon alfa-2b for PV pharmaessentia.com ↗
The Health Canada has Accepted the New Drug Submission of Ropeginterferon alfa-2b for PV |
| 2025-09-05 | PharmaEssentia | Regulatory Material Information - PharmaEssentia Files for an Additional Indication of Besremi (Ropeginterferon alfa-2b) for the Treatment of Essential Thrombocythemia (ET) with TFDA pharmaessentia.com ↗
Material Information - PharmaEssentia Files for an Additional Indication of Besremi (Ropeginterferon alfa-2b) for the Treatment of Essential Thrombocythemia (ET) with TFDA |
| 2025-07-18 | PharmaEssentia | Regulatory Material Information - The Company Announces Filing of New Drug Submission of BESREMi (Ropeginterferon alfa-2b) for PV in Canada pharmaessentia.com ↗
The Company Announces Filing of New Drug Submission of BESREMi (Ropeginterferon alfa-2b) for PV in Canada |
| 2025-07-16 | PharmaEssentia | Regulatory Material Information - The China NMPA has Accepted the Marketing Authorization Application of Ropeginterferon alfa-2b for ET pharmaessentia.com ↗
The China NMPA has Accepted the Marketing Authorization Application of Ropeginterferon alfa-2b for ET |
| 2025-06-30 | PharmaEssentia | Regulatory Material Information - The Company Announces Submission of Marketing Authorization Application of Ropeginterferon alfa-2b (P1101) for ET in China pharmaessentia.com ↗
The Company Announces Submission of Marketing Authorization Application of Ropeginterferon alfa-2b (P1101) for ET in China |
| 2025-06-18 | PharmaEssentia | Regulatory Material Information - Argentina ANMAT has Approved the Marketing Authorization Application of BESREMi (Ropeginterferon alfa-2b) for PV pharmaessentia.com ↗
Argentina ANMAT has Approved the Marketing Authorization Application of BESREMi (Ropeginterferon alfa-2b) for PV |
| 2025-04-01 | PharmaEssentia | Regulatory Material Information - The Company Announces Submission of Marketing Authorization Application of BESREMi (Ropeginterferon alfa-2b) for PV in Vietnam pharmaessentia.com ↗
The Company Announces Submission of Marketing Authorization Application of BESREMi (Ropeginterferon alfa-2b) for PV in Vietnam |
All press releases naming this drug 17 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 41 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 ↗25“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 NCT05481151 ↗ |
| 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 ↗ |