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P1101 + Ribavirin
P1101 + Ribavirin is a Interferon lambda + nucleoside analog antiviral Small molecule drug developed by PharmaEssentia. It is currently in Phase 3 development for Chronic hepatitis C virus infection (genotype-dependent). Also known as: Ropeginterferon alfa-2b.
P1101 is an interferon lambda that enhances antiviral immunity, combined with ribavirin, a nucleoside analog that inhibits viral RNA synthesis.
P1101, a small molecule inosine-5'-monophosphate dehydrogenase 1 inhibitor, was studied in combination with Ribavirin for the treatment of Chronic Hepatitis C Virus Infection and Hepatitis C. This combination was evaluated in a Phase 3 clinical trial (NCT04382937) for its efficacy compared to PEG-Intron + Ribavirin and PEGASYS 180 µg Q1W.
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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 | P1101 + Ribavirin |
|---|---|
| Also known as | Ropeginterferon alfa-2b |
| Sponsor | PharmaEssentia |
| Drug class | Interferon lambda + nucleoside analog antiviral |
| Target | Interferon lambda receptor (IFNLR1); viral RNA-dependent RNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | Phase 3 |
Mechanism of action
P1101 (interferon lambda-1b) activates innate immune responses through the interferon lambda receptor, promoting antiviral state in infected cells. Ribavirin is a broad-spectrum antiviral that inhibits viral RNA-dependent RNA polymerase and inosine monophosphate dehydrogenase. Together, they provide complementary antiviral mechanisms targeting hepatitis C virus replication and immune activation.
Approved indications
- Chronic hepatitis C virus infection (genotype-dependent)
Common side effects
- Fatigue
- Headache
- Anemia
- Flu-like symptoms
- Elevated transaminases
Key clinical trials
- The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection (PHASE1)
- Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection (PHASE3)
- Dose Finding Study of Pegylated-P-Interferon-alpha-2b(P1101) in Treatment-Naive Subjects With Hepatitis C Virus Genotype 1 Infection (PHASE2)
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:
- P1101 + Ribavirin CI brief — competitive landscape report
- P1101 + Ribavirin updates RSS · CI watch RSS
- PharmaEssentia portfolio CI
Frequently asked questions about P1101 + Ribavirin
What is P1101 + Ribavirin?
How does P1101 + Ribavirin work?
What is P1101 + Ribavirin used for?
Who makes P1101 + Ribavirin?
Is P1101 + Ribavirin also known as anything else?
What drug class is P1101 + Ribavirin in?
What development phase is P1101 + Ribavirin in?
What are the side effects of P1101 + Ribavirin?
What does P1101 + Ribavirin target?
Related
- Drug class: All Interferon lambda + nucleoside analog antiviral drugs
- Target: All drugs targeting Interferon lambda receptor (IFNLR1); viral RNA-dependent RNA polymerase
- Manufacturer: PharmaEssentia — full pipeline
- Therapeutic area: All drugs in Virology / Hepatology
- Indication: Drugs for Chronic hepatitis C virus infection (genotype-dependent)
- Also known as: Ropeginterferon alfa-2b
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing