BLASUBCUTANEOUSINJECTABLE
Approved
Nov 2021
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
5/8 — Partial
BESREMI (ropeginterferon alfa-2b) by PharmaEssentia is interferons, which exhibit their cellular effects in polycythemia vera in the bone marrow by binding to a transmembrane receptor termed interferon alfa receptor (ifnar). First approved in 2021.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BESREMI (ropeginterferon alfa-2b) is a pegylated interferon alfa-2b indicated for polycythemia vera, a myeloproliferative neoplasm. It works by binding to interferon alfa receptors (IFNAR) on bone marrow cells, triggering JAK1/TYK2/STAT signaling cascades that modulate gene expression and reduce pathologic hematopoiesis. The exact mechanisms underlying its therapeutic effects in PV remain partially elucidated.
$40MPart D
PeakPeak lifecycle stage with $40M Part D spending suggests mature commercial execution; brand and medical affairs teams are likely at steady-state with focused market defense strategies.
Mechanism of Action
interferons, which exhibit their cellular effects in polycythemia vera in the bone marrow by binding to a transmembrane receptor termed interferon alfa receptor (IFNAR). Binding to IFNAR initiates a downstream signaling cascade through the activation of kinases, in particular Janus kinase 1 (JAK1)…
Pharmacologic Class:
Interferon alfa-2b
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Started Sep 2026
35 enrolled
Atypical Chronic Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic/Myeloproliferative Neoplasm+2 more
Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis)
Started May 2026
15 enrolled
Myelofibrosis
Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)
Started Sep 2022
319 enrolled
Polycythemia Vera
The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
Started Aug 2022
20 enrolled
Chronic Hepatitis B InfectionChronic Hepatitis D Infection
Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance
Started Aug 2020
174 enrolled
Essential Thrombocythemia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.