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Drug

Ropeginterferon alfa-2b

Approved medicine
ClassInterferon alpha/beta receptor positive modulatorResearchOngoing clinical research

Also known as BESREMi, Pegylated proline interferon alpha-2b, Pegylated proline-interferon alpha-2b, Pegylated-proline-interferon alpha-2b.

RxNorm2587059ChEMBLCHEMBL4297819ATCL03AB15UNII981TME683S
9
Active clinical trials
2
Protein targets
4
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b (P1101) in Adult Patients With Pre-fibrotic/Early Primary Myelofibrosis (PMF) or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus (HOPE-PMF): The Core Study and Its Extension Study

Clinical trial2026-07-22Status changed to Active, not recruiting · ClinicalTrials.gov

Label change: ROPEGINTERFERON ALFA-2B (BLA761166)

Regulatory2026-06-26FDA

Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Clinical trial2026-06-11Results expected Q4 2029 · ClinicalTrials.gov

Ropeginterferon Alfa-2b for MDS/MPN Overlap Syndromes, Including CMML and MDS/MPN-RS-T

Clinical trial2026-05-06Results expected Q3 2031 · ClinicalTrials.gov

A Phase I/IB Study of Ropeginterferon in Patients With Cutaneous T-Cell Lymphoma (CTCL)

Clinical trial2026-04-01Results expected Q2 2028 · ClinicalTrials.gov

Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera - A Randomized Open Label Global Multicenter Study (PARADIGM-PV)

Clinical trial2025-07-31Results expected Q4 2026 · ClinicalTrials.gov

Efficacy and Safety of Ropeginterferon Alfa-2b for Pre-fibrotic Primary Myelofibrosis and DIPSS Low/Intermediate-1 Risk Myelofibrosis

Clinical trial2025-07-31Primary completion · ClinicalTrials.gov

Safety and Efficacy of Ropeginterferon Alfa-2b in Combination With Ruxolitinib in Patients With Myelofibrosis Demonstrating Suboptimal Response to Ruxolitinib Monotherapy

Clinical trial2025-06-11Results expected Q4 2026 · ClinicalTrials.gov

An Open-label, Randomized Study to Compare the Efficacy and Safety of P1101 Plus Tenofovir Alafenamide With or Without Ursodeoxycholic Acid in Patients With Chronic Hepatitis B and Hepatitis D Virus Co-Infection

Clinical trial2025-02-28Primary completion · ClinicalTrials.gov

Label change: ROPEGINTERFERON ALFA-2B (BLA761166)

Regulatory2024-04-29FDA

Approval: ROPEGINTERFERON ALFA-2B (BLA761166)

Regulatory2021-11-12FDA

Approval: Besremi (EMA)

Regulatory2019-02-15EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ropeginterferon alfa-2b
Aliases & brands
BESREMiPegylated proline interferon alpha-2bPegylated proline-interferon alpha-2bPegylated-proline-interferon alpha-2b
RxNorm CUI
2587059
ChEMBL ID
CHEMBL4297819
ATC codes
L03AB15
UNII
981TME683S
Primary mechanism
Interferon alpha/beta receptor positive modulator
Regulatory jurisdictions
emafda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interferon alpha/beta receptor 1
IFNAR1 · P17181
POSITIVE MODULATORInterferon alpha/beta receptor positive modulator
Interferon alpha/beta receptor 2
IFNAR2 · P48551
POSITIVE MODULATORInterferon alpha/beta receptor positive modulator

Regulatory timeline

4 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2019-02-15
Latest approval
2021-11-12
Authorities
FDA · EMA
Total events
4
fdaU.S. Food and Drug Administration· 3 events
2026-06-26Label change
Label change: ROPEGINTERFERON ALFA-2B (BLA761166)
Evidence ↗
2024-04-29Label change
Label change: ROPEGINTERFERON ALFA-2B (BLA761166)
Evidence ↗
2021-11-12Approval
Approval: ROPEGINTERFERON ALFA-2B (BLA761166)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2019-02-15Approval
Approval: Besremi (EMA)

Indication: Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

16 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
16
registered trials across all phases
LATEST COMPLETION 2021
9
Active studies
5
Recruiting
7
Late-stage (III+)
2
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 16
Phase 12Phase 27Phase 2 / 31Phase 34Phase 41Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera - A Randomized Open Label Global Multicenter Study (PARADIGM-PV)

Not yet recruitingPH IVPharmaEssentian=702027

A Phase 3, Open-Label, Multicenter, Randomized, Active-controlled Study to Assess PK and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as 2nd Line Therapy for Essential Thrombocythemia (SURPASS ET): The Core Study and Its Extension Study.

Active, not recruitingPH IIIPharmaEssentian=1742029

A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b (P1101) in Adult Patients With Pre-fibrotic/Early Primary Myelofibrosis (PMF) or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus (HOPE-PMF): The Core Study and Its Extension Study

Active, not recruitingPH IIIPharmaEssentian=1602029

A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients Who Are Intolerant or Refractory to or Not Eligible for Other Cytoreductive Treatments

Active, not recruitingPH IIIAOP Orphan Pharmaceuticals AGn=1172028

An Open Label, Control Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities

Unknown statusPH II/IIINational Taiwan University Hospitaln=602024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.