BLASUBCUTANEOUSINJECTABLE
Approved
Nov 2021
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
8
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 34m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BESREMI (ropeginterferon alfa-2b) is a long-acting interferon alfa-2b approved for polycythemia vera, a myeloproliferative neoplasm. It binds to interferon alfa receptor (IFNAR) on bone marrow cells, activating JAK1/TYK2/STAT signaling to modulate disease pathophysiology. The pegylated formulation enables less frequent dosing compared to conventional interferons.
$40MPart D
PeakProduct is at peak sales maturity with approximately 2,600 Part D claims in 2023; commercial team is likely stable or optimizing market penetration rather than launching or winding down.
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 (8)
A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in MDS/AML With TP53 Mutations
Started Oct 2026
30 enrolled
RopeginterferonAlfa-2bAzacitidine+1 more
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
Started Aug 2026
15 enrolled
Myelofibrosis
Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)
Started Sep 2022
429 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
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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.