BESREMI

(Ropeginterferon Alfa-2B)

ApprovedBiologic

PPharmaEssentia

BESREMI is one of 250 biologic programs targeting Polycythemia Vera. It is currently in Approved.

Indications

Total Trials

Active Trials

249

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Polycythemia VeraActive, not recruiting

Cutaneous T-Cell LymphomaActive, not recruiting

MyelofibrosisActive, not recruiting

Chronic Myelomonocytic LeukemiaActive, not recruiting

Hepatitis BActive, not recruiting

COVID-19Active, not recruiting

Myeloid LeukemiaActive, not recruiting

Essential ThrombocythemiaActive, not recruiting

Polycythemia VeraApproved

Active, not recruiting

Cutaneous T-Cell LymphomaPhase 1

Active, not recruiting

MyelofibrosisPhase 2

Active, not recruiting

Chronic Myelomonocytic LeukemiaPhase 2

Active, not recruiting

Hepatitis BPreclinical

Active, not recruiting

COVID-19Phase 2/Phase 3

Active, not recruiting

Myeloid LeukemiaPhase 2

Active, not recruiting

Essential ThrombocythemiaPhase 3

Active, not recruiting

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

BESREMI

PPharmaEssentia

Approved

1 2

Precedex

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

Preclinical

1 3

Tricor

JJagotec

Preclinical

1 4

Piperacillin/tazobactam

Pfizer

Preclinical

1 5

Statin

Bristol-Myers Squibb

Preclinical

1 6

Calcium

Aprotinin

1 8

Antithrombin-III

Octapharma

Preclinical

1 9

COVID-19 Vaccines

UUniversity of British Columbia

Hymecromone

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

Timeline

Expected Milestones

Q2 2027

Post-ApprovalNot yet recruiting

Polycythemia Vera

NCT06290765

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

Clinical

Trials by Indication[1]

Myelofibrosis4 trials

P1101 in Treating Patients With Myelofibrosis

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

Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis

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

Polycythemia Vera3 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

Not yet recruiting·PPharmaEssentia·Phase 4·NCT06290765·70 enrolled

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

Efficacy and Safety2 trials

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

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

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

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

7 more indications

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

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

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

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07269470·40 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

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

Essential Thrombocythemia1 trial

Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

Active, not recruiting·PPharmaEssentia·Phase 3·NCT04285086·174 enrolled

Unspecified1 trial

P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk

Recruiting·PPharmaEssentia·Phase 3·NCT06468033·150 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 12, 2021

BESREMI

BLA BLA761166

Sources

References

[1]
ClinicalTrials.gov — 18 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

Q2 2027

Q3 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Myelofibrosis4 trials

Polycythemia Vera3 trials

Efficacy and Safety2 trials

COVID-191 trial

Tics1 trial

Chronic Myelomonocytic Leukemia1 trial

Hepatitis B1 trial

Myeloid Leukemia1 trial

Cutaneous T-cell lymphoma1 trial

Infection1 trial

Essential Thrombocythemia1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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