ROPEGINTERFERON ALFA-2B
drugOn this page
Also known as Aop2014BesremiP-1101P1101Ropeginterferon alfa-2b njftRopeginterferon alfa-2b-njft
Summary
Ropeginterferon Alfa-2B (CHEMBL4297819) is an approved protein (ATC L03AB15); indicated across 10 conditions including acquired polycythemia vera and neoplasm.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Protein
- ATC class: L03AB15
- Indications: 10 conditions
- Clinical trials: 23
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4297819 |
| Name | ROPEGINTERFERON ALFA-2B |
| Type | Protein |
| Max phase | 4 |
| ATC | L03AB15 |
Also known as: Aop2014, Besremi, P-1101, P1101, Ropeginterferon alfa-2b, Ropeginterferon alfa-2b njft, Ropeginterferon alfa-2b-njft, ROPEGINTERFERON ALFA-2B
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
10 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| acquired polycythemia vera | 4 | MONDO:0009891 | EFO:0002429 |
| neoplasm | 4 | MONDO:0005070 | EFO:0000616 |
| essential thrombocythemia | 3 | MONDO:0005029 | EFO:0000479 |
| chronic hepatitis C virus infection | 3 | MONDO:0005354 | EFO:0004220 |
| severe acute respiratory syndrome | 3 | MONDO:0005091 | MONDO:0100096 |
| hepatitis D virus infection | 2 | MONDO:0005789 | EFO:0007304 |
| primary myelofibrosis | 2 | MONDO:0009692 | MONDO:0044903 |
| chronic myeloid leukemia | 1 | MONDO:0011996 | EFO:0000339 |
| hepatocellular carcinoma | 1 | MONDO:0007256 | EFO:0000182 |
| chronic hepatitis B virus infection | 1 | MONDO:0005366 | EFO:0004239 |
Clinical trials
Total trials: 23.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 8 |
| PHASE1 | 6 |
| PHASE3 | 5 |
| Not specified | 2 |
| PHASE4 | 1 |
| PHASE2/PHASE3 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT06290765 | PHASE4 | NOT_YET_RECRUITING | Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera |
| NCT04285086 | PHASE3 | ACTIVE_NOT_RECRUITING | Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance |
| NCT06468033 | PHASE3 | RECRUITING | P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk |
| NCT03117816 | PHASE3 | COMPLETED | ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission |
| NCT04382937 | PHASE3 | COMPLETED | Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection |
| NCT05808322 | PHASE2/PHASE3 | UNKNOWN | Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities |
| NCT06002490 | PHASE3 | COMPLETED | A Study to Evaluate P1101 in Japanese PV Patients |
| NCT05485948 | PHASE2 | ACTIVE_NOT_RECRUITING | A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU |
| NCT07468916 | PHASE2 | NOT_YET_RECRUITING | Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia |
| NCT01587586 | PHASE2 | COMPLETED | Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection |
| NCT02370329 | PHASE2 | TERMINATED | P1101 in Treating Patients With Myelofibrosis |
| NCT03003325 | PHASE2 | COMPLETED | The Benefit/Risk Profile of AOP2014 in Low-risk Patients With PV |
| NCT04182100 | PHASE2 | COMPLETED | Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply |
| NCT04988815 | PHASE2 | UNKNOWN | Ropeginterferon Alfa 2b for Early Myelofibrosis |
| NCT05467553 | PHASE2 | UNKNOWN | A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection |
| NCT07047885 | PHASE1 | RECRUITING | Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL) |
| NCT01933906 | PHASE1 | COMPLETED | Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response |
| NCT03546465 | PHASE1 | COMPLETED | Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects |
| NCT04638439 | PHASE1 | COMPLETED | 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 |
| NCT04774107 | PHASE1 | COMPLETED | The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection |
| NCT05129644 | PHASE1 | COMPLETED | Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects |
| NCT06506084 | Not specified | ACTIVE_NOT_RECRUITING | Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV) |
| NCT05494528 | Not specified | UNKNOWN | Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).