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Peginterferon α2b
Peginterferon α2b is a Interferon Small molecule drug developed by University of Jena. It is currently in Phase 3 development for Chronic hepatitis C, Chronic hepatitis B. Also known as: Redipen.
Peginterferon α2b works by stimulating the body's immune system to fight viral infections.
Peginterferon α2b is a protein-based drug that acts as an agonist to the interferon alpha/beta receptor. It has been studied in clinical trials for various conditions, including Chronic Myeloid Leukemia, Lymphoma, Chronic Hepatitis B, and HBV.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Peginterferon α2b |
|---|---|
| Also known as | Redipen |
| Sponsor | University of Jena |
| Drug class | Interferon |
| Target | IFNAR |
| Modality | Small molecule |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
It does this by inducing the production of antiviral proteins and activating immune cells to target and eliminate infected cells. Peginterferon α2b is a pegylated form of interferon α2b, which allows for a longer duration of action and reduced dosing frequency.
Approved indications
- Chronic hepatitis C
- Chronic hepatitis B
Common side effects
- Flu-like symptoms
- Fatigue
- Headache
Key clinical trials
- Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma (PHASE2)
- Safety, Tolerability, and Preliminary Efficacy of Peginterferon α-2b in Combination With an Anti-PD-1 Antibody in Patients With Advanced or Metastatic Malignant Solid Tumors (NA)
- Peginterferon α-2b Injection for Hydroxyurea Resistant or Intolerant ET (PHASE2)
- Prospective Cohort Study on PEG-IFN-α-2b in Improving Clinical Cure Rate of Pediatric Patients With Chronic Hepatitis B (PHASE4)
- A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis (NA)
- Observation Study on Reducing the Risk of Liver Cancer Associated With Hepatitis B (Zhiyuan) Project.
- Clinical Trial of Pegylated Interferon α-2b Via Nebulization for Treatment of Hand, Foot, and Mouth Disease . (NA)
- Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients (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:
- Peginterferon α2b CI brief — competitive landscape report
- Peginterferon α2b updates RSS · CI watch RSS
- University of Jena portfolio CI
Frequently asked questions about Peginterferon α2b
What is Peginterferon α2b?
How does Peginterferon α2b work?
What is Peginterferon α2b used for?
Who makes Peginterferon α2b?
Is Peginterferon α2b also known as anything else?
What drug class is Peginterferon α2b in?
What development phase is Peginterferon α2b in?
What are the side effects of Peginterferon α2b?
What does Peginterferon α2b target?
Related
- Drug class: All Interferon drugs
- Target: All drugs targeting IFNAR
- Manufacturer: University of Jena — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Chronic hepatitis C
- Indication: Drugs for Chronic hepatitis B
- Also known as: Redipen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing