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Pegylated-Proline-interferon alpha-2b
Pegylated-Proline-interferon alpha-2b is a Pegylated interferon alpha Small molecule drug developed by AOP Orphan Pharmaceuticals AG. It is currently in Phase 3 development for Chronic hepatitis C, Chronic hepatitis B. Also known as: AOP2014.
Pegylated-Proline-interferon alpha-2b is a modified interferon alpha-2b with extended half-life that activates innate immune responses through interferon-alpha receptor signaling.
Pegylated-Proline-interferon alpha-2b is a modified interferon alpha-2b with extended half-life that activates innate immune responses through interferon-alpha receptor signaling. Used for Chronic hepatitis C, Chronic hepatitis B.
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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).
| 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-Proline-interferon alpha-2b |
|---|---|
| Also known as | AOP2014 |
| Sponsor | AOP Orphan Pharmaceuticals AG |
| Drug class | Pegylated interferon alpha |
| Target | Interferon-alpha receptor (IFNAR) |
| Modality | Small molecule |
| Therapeutic area | Virology/Hepatology |
| Phase | Phase 3 |
Mechanism of action
This drug combines interferon alpha-2b, a cytokine that stimulates antiviral and anti-tumor immune responses, with pegylation and proline modification to improve pharmacokinetics and reduce dosing frequency. The pegylation extends circulating half-life, while the proline modification may enhance stability and reduce immunogenicity. It binds to interferon-alpha receptors on immune cells and hepatocytes to induce antiviral and immunomodulatory effects.
Approved indications
- Chronic hepatitis C
- Chronic hepatitis B
Common side effects
- Flu-like symptoms (fever, fatigue, myalgia)
- Hematologic toxicity (thrombocytopenia, neutropenia)
- Psychiatric effects (depression, anxiety)
- Thyroid dysfunction
- Injection site reactions
Key clinical trials
- Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply (PHASE2)
- A Study to Evaluate P1101 in Japanese PV Patients (PHASE3)
- The Benefit/Risk Profile of AOP2014 in Low-risk Patients With PV (PHASE2)
- ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission (PHASE3)
- AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study. (PHASE3)
- Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera (PHASE1, PHASE2)
- Study to Assess the Self-administration of AOP2014 Using a Pen, Developed for the Treatment of Polycythemia Vera Patients (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-Proline-interferon alpha-2b CI brief — competitive landscape report
- Pegylated-Proline-interferon alpha-2b updates RSS · CI watch RSS
- AOP Orphan Pharmaceuticals AG portfolio CI
Frequently asked questions about Pegylated-Proline-interferon alpha-2b
What is Pegylated-Proline-interferon alpha-2b?
How does Pegylated-Proline-interferon alpha-2b work?
What is Pegylated-Proline-interferon alpha-2b used for?
Who makes Pegylated-Proline-interferon alpha-2b?
Is Pegylated-Proline-interferon alpha-2b also known as anything else?
What drug class is Pegylated-Proline-interferon alpha-2b in?
What development phase is Pegylated-Proline-interferon alpha-2b in?
What are the side effects of Pegylated-Proline-interferon alpha-2b?
What does Pegylated-Proline-interferon alpha-2b target?
Related
- Drug class: All Pegylated interferon alpha drugs
- Target: All drugs targeting Interferon-alpha receptor (IFNAR)
- Manufacturer: AOP Orphan Pharmaceuticals AG — full pipeline
- Therapeutic area: All drugs in Virology/Hepatology
- Indication: Drugs for Chronic hepatitis C
- Indication: Drugs for Chronic hepatitis B
- Also known as: AOP2014
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing