Last reviewed 2026-04-23 · How we verify

Interferon-Alfa 9MU

Pfizer · Phase 3 active Small molecule

Interferon-Alfa 9MU is a Cytokine; Interferon Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Chronic hepatitis C, Chronic hepatitis B, Melanoma.

Interferon-alfa activates the innate immune system by binding to interferon-alpha receptors on immune cells and tumor cells, enhancing antiviral and anti-tumor immune responses.

Interferon-alfa activates the innate immune system by binding to interferon-alpha receptors on immune cells and tumor cells, enhancing antiviral and anti-tumor immune responses. Used for Chronic hepatitis C, Chronic hepatitis B, Melanoma.

Likelihood of approval

64.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
Big-pharma sponsor +3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Interferon-Alfa 9MU
Sponsor	Pfizer
Drug class	Cytokine; Interferon
Target	Interferon-alpha receptor (IFNAR)
Modality	Small molecule
Therapeutic area	Oncology; Immunology
Phase	Phase 3

Mechanism of action

Interferon-alfa is a cytokine that binds to type I interferon receptors (IFNAR1/IFNAR2) on cell surfaces, triggering JAK-STAT signaling pathways. This activation upregulates expression of interferon-stimulated genes, enhancing natural killer cell activity, macrophage function, and antigen presentation. It also has direct anti-proliferative and pro-apoptotic effects on tumor cells and can inhibit angiogenesis.

Approved indications

Chronic hepatitis C
Chronic hepatitis B
Melanoma
Renal cell carcinoma
Follicular lymphoma

Common side effects

Flu-like symptoms (fever, chills, fatigue)
Headache
Myalgia
Depression
Thrombocytopenia
Leukopenia
Elevated liver enzymes
Autoimmune thyroiditis

Key clinical trials

Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects (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:

Interferon-Alfa 9MU CI brief — competitive landscape report
Interferon-Alfa 9MU updates RSS · CI watch RSS
Pfizer portfolio CI

Frequently asked questions about Interferon-Alfa 9MU

What is Interferon-Alfa 9MU?

Interferon-Alfa 9MU is a Cytokine; Interferon drug developed by Pfizer, indicated for Chronic hepatitis C, Chronic hepatitis B, Melanoma.

How does Interferon-Alfa 9MU work?

Interferon-alfa activates the innate immune system by binding to interferon-alpha receptors on immune cells and tumor cells, enhancing antiviral and anti-tumor immune responses.

What is Interferon-Alfa 9MU used for?

Interferon-Alfa 9MU is indicated for Chronic hepatitis C, Chronic hepatitis B, Melanoma, Renal cell carcinoma, Follicular lymphoma.

Who makes Interferon-Alfa 9MU?

Interferon-Alfa 9MU is developed by Pfizer (see full Pfizer pipeline at /company/pfizer).

What drug class is Interferon-Alfa 9MU in?

Interferon-Alfa 9MU belongs to the Cytokine; Interferon class. See all Cytokine; Interferon drugs at /class/cytokine-interferon.

What development phase is Interferon-Alfa 9MU in?

Interferon-Alfa 9MU is in Phase 3.

What are the side effects of Interferon-Alfa 9MU?

Common side effects of Interferon-Alfa 9MU include Flu-like symptoms (fever, chills, fatigue), Headache, Myalgia, Depression, Thrombocytopenia, Leukopenia.

What does Interferon-Alfa 9MU target?

Interferon-Alfa 9MU targets Interferon-alpha receptor (IFNAR) and is a Cytokine; Interferon.

Drug class: All Cytokine; Interferon drugs
Target: All drugs targeting Interferon-alpha receptor (IFNAR)
Manufacturer: Pfizer — full pipeline
Therapeutic area: All drugs in Oncology; Immunology
Indication: Drugs for Chronic hepatitis C
Indication: Drugs for Chronic hepatitis B
Indication: Drugs for Melanoma

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing