Last reviewed 2026-04-23 · How we verify

Interferon β-1a 30 µg

Novartis · Phase 3 active Small molecule

Interferon β-1a 30 µg is a Interferon Small molecule drug developed by Novartis. It is currently in Phase 3 development for Relapsing-remitting multiple sclerosis, Secondary progressive multiple sclerosis with active disease.

Interferon β-1a activates interferon-beta receptors on immune cells to enhance antiviral and immunomodulatory responses, reducing inflammation and immune-mediated demyelination.

Interferon β-1a activates interferon-beta receptors on immune cells to enhance antiviral and immunomodulatory responses, reducing inflammation and immune-mediated demyelination. Used for Relapsing-remitting multiple sclerosis, Secondary progressive multiple sclerosis with active disease.

Likelihood of approval

62.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
Big-pharma sponsor +3.0pp
Novartis 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 β-1a 30 µg
Sponsor	Novartis
Drug class	Interferon
Target	Interferon-beta receptor (IFNAR1/IFNAR2)
Modality	Small molecule
Therapeutic area	Immunology
Phase	Phase 3

Mechanism of action

Interferon β-1a is a recombinant cytokine that binds to type I interferon receptors (IFNAR1/IFNAR2) on the surface of immune cells and other tissues. This activation upregulates antiviral genes, enhances natural killer cell activity, and shifts the immune response from pro-inflammatory Th1/Th17 toward anti-inflammatory Th2 responses. In multiple sclerosis, this mechanism reduces the frequency and severity of relapses by suppressing autoreactive T cell infiltration into the central nervous system.

Approved indications

Relapsing-remitting multiple sclerosis
Secondary progressive multiple sclerosis with active disease

Common side effects

Injection site reactions
Flu-like symptoms (fever, chills, myalgia)
Headache
Fatigue
Elevated liver enzymes
Lymphopenia
Depression

Key clinical trials

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 β-1a 30 µg CI brief — competitive landscape report
Interferon β-1a 30 µg updates RSS · CI watch RSS
Novartis portfolio CI

Frequently asked questions about Interferon β-1a 30 µg

What is Interferon β-1a 30 µg?

Interferon β-1a 30 µg is a Interferon drug developed by Novartis, indicated for Relapsing-remitting multiple sclerosis, Secondary progressive multiple sclerosis with active disease.

How does Interferon β-1a 30 µg work?

Interferon β-1a activates interferon-beta receptors on immune cells to enhance antiviral and immunomodulatory responses, reducing inflammation and immune-mediated demyelination.

What is Interferon β-1a 30 µg used for?

Interferon β-1a 30 µg is indicated for Relapsing-remitting multiple sclerosis, Secondary progressive multiple sclerosis with active disease.

Who makes Interferon β-1a 30 µg?

Interferon β-1a 30 µg is developed by Novartis (see full Novartis pipeline at /company/novartis).

What drug class is Interferon β-1a 30 µg in?

Interferon β-1a 30 µg belongs to the Interferon class. See all Interferon drugs at /class/interferon.

What development phase is Interferon β-1a 30 µg in?

Interferon β-1a 30 µg is in Phase 3.

What are the side effects of Interferon β-1a 30 µg?

Common side effects of Interferon β-1a 30 µg include Injection site reactions, Flu-like symptoms (fever, chills, myalgia), Headache, Fatigue, Elevated liver enzymes, Lymphopenia.

What does Interferon β-1a 30 µg target?

Interferon β-1a 30 µg targets Interferon-beta receptor (IFNAR1/IFNAR2) and is a Interferon.

Drug class: All Interferon drugs
Target: All drugs targeting Interferon-beta receptor (IFNAR1/IFNAR2)
Manufacturer: Novartis — full pipeline
Therapeutic area: All drugs in Immunology
Indication: Drugs for Relapsing-remitting multiple sclerosis
Indication: Drugs for Secondary progressive multiple sclerosis with active disease

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