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DRUG CLASS:

IFNα 2b stimulant

16d
Ropeginterferon alfa-2b in Polycythemia Vera: redefining disease control through molecular targeting. (PubMed, Expert Rev Anticancer Ther)
Its favorable efficacy-toxicity balance and convenient dosing support long-term use, particularly in younger or treatment-naïve patients. Future research should refine patient selection, explore predictive biomarkers, and define its role among disease-modifying agents capable of transforming PV into a chronic, potentially controllable disorder.
Review • Journal
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JAK2 (Janus kinase 2)
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Besremi (ropeginterferon alfa-2b-njft)
21d
Efficacy and safety of ropeginterferon alfa-2b in the treatment of polycythemia vera: a systematic review with single arm meta-analysis. (PubMed, Ann Hematol)
The most common adverse events were elevated liver enzymes (AST: 0.28; ALT: 0.32), influenza-like illness (0.11), and anemia (0.09), with unresolved heterogeneity in all outcomes.Ropeginterferon alfa-2b shows promising efficacy in achieving hematological and molecular responses in patients with PV. However, notable heterogeneity and safety concerns, particularly liver-related adverse effects, warrant further investigation in large-scale trials.
Retrospective data • Review • Journal
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JAK2 (Janus kinase 2)
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Besremi (ropeginterferon alfa-2b-njft)
30d
Ropeginterferon alfa-2b in hydroxyurea-intolerant or hydroxyurea-refractory essential thrombocythaemia (SURPASS ET): a multicentre, open-label, randomised, active-controlled, phase 3 study. (PubMed, Lancet Haematol)
Our findings suggest that ropeginterferon alfa-2b could be considered as a second-line treatment option for patients with essential thrombocythaemia and leukocytosis.
Clinical • P3 data • Journal
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JAK2 (Janus kinase 2)
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hydroxyurea • Besremi (ropeginterferon alfa-2b-njft)
1m
Effective Treatment with Ruxolitinib and Ropeginterferon Alfa-2b for Refractory TAFRO-like Syndrome. (PubMed, Intern Med)
The Janus kinase (JAK)/signal transducers and activators of transcription (STAT) pathway has recently been shown to play an important role in the pathogenesis of inflammation in TAFRO syndrome, and inhibitors of the JAK/STAT pathway may be effective as therapeutic agents for TAFRO syndrome. We herein report the successful treatment using combination therapy with ruxolitinib and ropeginterferon alfa-2b of a case of TAFRO-like syndrome with a long history of polycythemia vera with JAK2 V617F refractory to several treatments.
Journal
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JAK2 (Janus kinase 2)
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Jakafi (ruxolitinib) • Besremi (ropeginterferon alfa-2b-njft)
1m
P1101 in Treating Patients With Myelofibrosis (clinicaltrials.gov)
P2, N=11, Terminated, Mayo Clinic | Completed --> Terminated; Study drug became commercially available
Trial termination
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Besremi (ropeginterferon alfa-2b-njft)
2ms
Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL) (clinicaltrials.gov)
P1, N=38, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Initiation date: Dec 2025 --> Aug 2025
Trial initiation date
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Besremi (ropeginterferon alfa-2b-njft)
3ms
TYK2 is essential for the therapeutic effect of IFN-α in Jak2V617F-induced murine myeloproliferative neoplasms. (PubMed, Blood Neoplasia)
Most effects of IFN-α on Jak2V617F cells were preserved in Jak2V617F;Stat1 -/- mice but to a moderate degree compared with Jak2V617F mice. Our study reveals essential roles of TYK2 for the preferential suppressive effect of IFN-α on Jak2V617F progenitors and HSCs.
Preclinical • Journal
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JAK1 (Janus Kinase 1) • TYK2 (Tyrosine Kinase 2) • STAT1 (Signal Transducer And Activator Of Transcription 1) • IFNA1 (Interferon Alpha 1)
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Besremi (ropeginterferon alfa-2b-njft)
3ms
Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL) (clinicaltrials.gov)
P1, N=38, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Initiation date: Jul 2025 --> Dec 2025
Trial initiation date
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Besremi (ropeginterferon alfa-2b-njft)
4ms
EXCEED ET: A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET (clinicaltrials.gov)
P2, N=91, Active, not recruiting, PharmaEssentia | Trial primary completion date: Mar 2027 --> May 2025
Trial primary completion date
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JAK2 (Janus kinase 2)
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Besremi (ropeginterferon alfa-2b-njft)
4ms
ECLIPSE-PV: A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV (clinicaltrials.gov)
P3, N=111, Active, not recruiting, PharmaEssentia | Trial completion date: Jul 2025 --> Jul 2027 | Trial primary completion date: Dec 2024 --> Jun 2025
Trial completion date • Trial primary completion date
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Besremi (ropeginterferon alfa-2b-njft)
4ms
Trial completion date
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hydroxyurea • Besremi (ropeginterferon alfa-2b-njft)
4ms
Core Study: P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk (clinicaltrials.gov)
P3, N=150, Recruiting, PharmaEssentia | Not yet recruiting --> Recruiting | Trial completion date: Apr 2028 --> Sep 2028 | Trial primary completion date: Mar 2027 --> Sep 2027
Enrollment open • Trial completion date • Trial primary completion date
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Besremi (ropeginterferon alfa-2b-njft)