MedPath

Ropeginterferon alfa-2b

Generic Name
Ropeginterferon alfa-2b
Brand Names
Besremi
Drug Type
Biotech
CAS Number
1335098-50-4
Unique Ingredient Identifier
981TME683S

Overview

Polycythemia vera (PV) is the most common Philadelphia chromosome-negative myeloproliferative neoplasm (MPN), characterized by increased hematocrit and platelet/leukocyte counts, an increased risk for hemorrhage and thromboembolic events, and a long-term propensity for myelofibrosis and leukemia. Interferon alfa-2b has been used for decades to treat PV but requires frequent dosing and is not tolerated by all patients. Ropeginterferon alfa-2b is a next-generation mono-pegylated type I interferon produced from proline-IFN-α-2b in Escherichia coli that has high tolerability and a long half-life. Ropeginterferon alfa-2b has shown efficacy in PV in in vitro and in vivo models and clinical trials. Ropeginterferon alfa-2b was approved by the FDA on November 12, 2021, and is currently marketed under the trademark BESREMi by PharmaEssentia Corporation.

Indication

Ropeginterferon alfa-2b is indicated for the treatment of adult patients with polycythemia vera.

Associated Conditions

  • Polycythemia Vera (PV)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/02
Not Applicable
Recruiting
2024/07/17
N/A
Recruiting
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
2024/06/21
Phase 3
Not yet recruiting
PharmaEssentia
2024/03/04
Phase 4
Not yet recruiting
PharmaEssentia
2023/08/21
Phase 3
Completed
PharmaEssentia Japan K.K.
2023/04/11
Phase 2
Not yet recruiting
2022/08/10
Not Applicable
Recruiting
2022/08/03
Phase 2
Active, not recruiting
PharmaEssentia
2022/07/20
Phase 2
Not yet recruiting
2021/08/04
Phase 2
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
PharmaEssentia USA
73536-500
SUBCUTANEOUS
500 ug in 1 mL
1/12/2024

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
2/15/2019

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
Besremi Solution for Injection in Prefilled Syringe 500 micrograms/mL
SIN17014P
INJECTION, SOLUTION
500 µg/mL
5/29/2024

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
BESREMI 250 MICROGRAMOS/0,5 ML DE SOLUCION PARA INYECCION EN PLUMA PRECARGADA
1181352001
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Diagnóstico Hospitalario
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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