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Pegylated Interferon α2
Pegylated Interferon α2 is a Interferon Small molecule drug developed by Sheikh Zayed Medical College. It is currently in Phase 3 development for Chronic hepatitis C, Chronic hepatitis B, Certain malignancies (melanoma, lymphoma). Also known as: Unipg.
Pegylated Interferon α2 activates innate immune responses by binding to interferon-alpha receptors, enhancing antiviral and anti-proliferative activity.
Pegylated Interferon α2 is a protein-based treatment used to study and treat various conditions, including Hepatitis C, Hepatitis C Relapse, Hepatitis B, and Hepatitis C Virus Infection. It is often used in combination with other treatments, such as Ribavirin or nucleos(t)ide analogues, as part of clinical trials to evaluate its effectiveness in these conditions.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Pegylated Interferon α2 |
|---|---|
| Also known as | Unipg |
| Sponsor | Sheikh Zayed Medical College |
| Drug class | Interferon |
| Target | Interferon-alpha receptor (IFNAR) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Interferon α2 is a cytokine that binds to type I interferon receptors on cell surfaces, triggering JAK-STAT signaling pathways that upregulate antiviral genes and enhance natural killer cell and macrophage activity. Pegylation extends the drug's half-life by reducing renal clearance and proteolytic degradation, allowing for less frequent dosing while maintaining therapeutic levels. This mechanism makes it effective against viral infections and certain malignancies.
Approved indications
- Chronic hepatitis C
- Chronic hepatitis B
- Certain malignancies (melanoma, lymphoma)
Common side effects
- Flu-like symptoms (fever, chills, fatigue)
- Headache
- Myalgia
- Depression/mood changes
- Thrombocytopenia
- Neutropenia
- Elevated liver enzymes
Key clinical trials
- Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4 (PHASE1, PHASE2)
- To Study the Effect of Adding on Pegylated Interferon (PEG-INF) Therapy for Patients Diagnosed With Chronic Hepatitis B (PHASE4)
- Impact of Interleukin 28B (rs12979860) Genotype on Virological Responses Chronic Hepatitis C Treatment (PHASE3)
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 α2 CI brief — competitive landscape report
- Pegylated Interferon α2 updates RSS · CI watch RSS
- Sheikh Zayed Medical College portfolio CI
Frequently asked questions about Pegylated Interferon α2
What is Pegylated Interferon α2?
How does Pegylated Interferon α2 work?
What is Pegylated Interferon α2 used for?
Who makes Pegylated Interferon α2?
Is Pegylated Interferon α2 also known as anything else?
What drug class is Pegylated Interferon α2 in?
What development phase is Pegylated Interferon α2 in?
What are the side effects of Pegylated Interferon α2?
What does Pegylated Interferon α2 target?
Related
- Drug class: All Interferon drugs
- Target: All drugs targeting Interferon-alpha receptor (IFNAR)
- Manufacturer: Sheikh Zayed Medical College — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Chronic hepatitis C
- Indication: Drugs for Chronic hepatitis B
- Indication: Drugs for Certain malignancies (melanoma, lymphoma)
- Also known as: Unipg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing