BESREMI

(Ropeginterferon Alfa-2B)

ApprovedBiologic

PPharmaEssentia

BESREMI is one of 173 biologic programs targeting Hepatitis B. It is currently in Approved.

Indications

Total Trials

Active Trials

172

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Hepatitis BActive, not recruiting

Primary MyelofibrosisActive, not recruiting

Chronic Myeloid LeukemiaRecruiting

RopeginterferonNot yet recruiting

Efficacy and SafetyActive, not recruiting

Cutaneous T-Cell LymphomaRecruiting

MyelofibrosisTerminated

Chronic Myelomonocytic LeukemiaNot yet recruiting

Essential ThrombocythemiaActive, not recruiting

Polycythemia VeraWithdrawn

Hepatitis BPreclinical

Active, not recruiting

Primary MyelofibrosisPhase 3

Active, not recruiting

Chronic Myeloid LeukemiaPhase 2

Recruiting

RopeginterferonPreclinical

Not yet recruiting

Efficacy and SafetyPhase 3

Active, not recruiting

Cutaneous T-Cell LymphomaPhase 1

Recruiting

MyelofibrosisPhase 2

Terminated

Chronic Myelomonocytic LeukemiaPhase 2

Not yet recruiting

Essential ThrombocythemiaPhase 3

Active, not recruiting

Polycythemia VeraApproved

Withdrawn

Competition

Competitive Landscape

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

BESREMI

PPharmaEssentia

Approved

2 2

Rinvoq

AbbVie

Phase 3

4 3

Savaysa

Daiichi Sankyo

Phase 3

3 4

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

7 5

Rapamune

PPrism Pharmaceuticals

Phase 3

5 6

Rilutek

AAzurity Pharmaceuticals

Phase 3

3 7

Kineret

SSwedish Orphan Biovitrum

Phase 3

2 8

UPLIZNA

HHorizon Therapeutics Ireland DAC

Phase 3

1 9

Apatinib Mesylate

BBukwang Pharmaceutical

Phase 3

1 10

Becotatug Vedotin

FFudan University

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 2Active, not recruiting

Efficacy and Safety

NCT05485948

Q4 2027

Phase 2Recruiting

Myelofibrosis

NCT06770842

Q1 2028

Phase 3Active, not recruiting

Efficacy and Safety

NCT06514807

Q2 2028

Phase 1Recruiting

Cutaneous T-Cell Lymphoma

NCT07047885

Clinical

Trials by Indication[1]

Polycythemia Vera4 trials

Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter Study

Not yet recruiting·FFederico II University··NCT07282132·150 enrolled

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

Withdrawn·PPharmaEssentia·Approved·NCT06290765

A Phase 2/3, Randomized, Open-label, Active-comparator-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543) Versus Best Available Therapy in Participants With Polycythemia Vera Who Have an Inadequate Response to or Are Intolerant to Hydroxyurea

Not yet recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT07722611·380 enrolled

Show 1 more trial

Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)

Recruiting·FFROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS··NCT06506084·429 enrolled

Myelofibrosis4 trials

Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis

Recruiting·TThe University of Hong Kong·Phase 2·NCT06770842·20 enrolled

P1101 in Treating Patients With Myelofibrosis

Terminated·MMayo Clinic·Phase 2·NCT02370329·11 enrolled

Ropeginterferon Alfa 2b for Early Myelofibrosis

Unknown status·TThe University of Hong Kong·Phase 2·NCT04988815·50 enrolled

Show 1 more trial

A Phase 1b Study of Safety, Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis)

Not yet recruiting·UUniversity of Utah·Phase 1·NCT07521046·15 enrolled

Efficacy and Safety2 trials

A Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients

Active, not recruiting·AAOP Orphan Pharmaceuticals AG·Phase 3·NCT06514807·117 enrolled

A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU

Active, not recruiting·PPharmaEssentia·Phase 2·NCT05485948·49 enrolled

COVID-191 trial

Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities

Unknown status·NNational Taiwan University Hospital·Phase 2/3·NCT05808322·60 enrolled

Infection1 trial

A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection

Unknown status·NNational Taiwan University Hospital·Phase 2·NCT05467553·30 enrolled

8 more indications

Hepatitis B1 trial

Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy

Unknown status·NNational Taiwan University Hospital·N/A·NCT05494528·90 enrolled

Cutaneous T-cell lymphoma1 trial

Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT07047885·38 enrolled

Chronic Myelomonocytic Leukemia1 trial

Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia

Not yet recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT07468916·35 enrolled

Tics1 trial

Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects

Completed·PPharmaEssentia Japan K.K.·Phase 1·NCT03546465·36 enrolled

Ropeginterferon1 trial

A Phase 1b/2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in Newly Diagnosed MDS/AML (≥ 10% Blasts) With TP53 Mutations

Not yet recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT07646821·30 enrolled

Chronic Myeloid Leukemia1 trial

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

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07269470·40 enrolled

Primary Myelofibrosis1 trial

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 recruiting·PPharmaEssentia·Phase 3·NCT06468033·160 enrolled

Essential Thrombocythemia1 trial

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 recruiting·PPharmaEssentia·Phase 3·NCT04285086·174 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 12, 2021

BESREMI

BLA BLA761166

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Ropeginterferon Alfa-2B. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ropeginterferon Alfa-2B compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ropeginterferon Alfa-2B. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761166). U.S. Food & Drug Administration.
[5]
SEC EDGAR — PharmaEssentia company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Approved[1]
Company: PPharmaEssentia

BESREMI

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q1 2028

Q2 2028

Trials by Indication[1]

Polycythemia Vera4 trials

Myelofibrosis4 trials

Efficacy and Safety2 trials

COVID-191 trial

Infection1 trial

Hepatitis B1 trial

Cutaneous T-cell lymphoma1 trial

Chronic Myelomonocytic Leukemia1 trial

Tics1 trial

Ropeginterferon1 trial

Chronic Myeloid Leukemia1 trial

Primary Myelofibrosis1 trial

Essential Thrombocythemia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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