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Pegylated Interferon-α2b
Pegylated Interferon-α2b is a Small molecule drug developed by Zydus Lifesciences Limited. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Pegylated Interferon-α2b |
|---|---|
| Sponsor | Zydus Lifesciences Limited |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006) (PHASE3)
- Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma (PHASE2)
- A Clinical Study of Gecacitinib Combined With Pegylated Interferon in Patients With PV (NA)
- Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B (PHASE4)
- Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Active Chronic Hepatitis B (PHASE4)
- Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma (PHASE2)
- A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs (PHASE2)
- Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis B (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pegylated Interferon-α2b CI brief — competitive landscape report
- Pegylated Interferon-α2b updates RSS · CI watch RSS
- Zydus Lifesciences Limited portfolio CI
Frequently asked questions about Pegylated Interferon-α2b
What is Pegylated Interferon-α2b?
Who makes Pegylated Interferon-α2b?
What development phase is Pegylated Interferon-α2b in?
Related
- Manufacturer: Zydus Lifesciences Limited — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing