AVONEX (interferon beta-1a)
AVONEX is indicated for the treatment of Multiple Sclerosis.
How AVONEX Works
AVONEX is classified as an interferon beta. The specific mechanism of action by which the drug exerts its therapeutic effects in patients with multiple sclerosis is currently unknown. While the drug is used to treat relapsing forms of the disease, the precise biological pathways involved in its efficacy have not been established.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1996-05-17
- Patent Cliff
- 2003
- Revenue
- $180M (Q4-2025)
- Routes
- N/A
- Dosage Forms
- VIAL
AVONEX Approval History
What AVONEX Treats
1 indicationsAVONEX is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
AVONEX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in AVONEX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AVONEX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AVONEX
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
27 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01892722 results posted | CFTY720D2311 2011-005677-23 | Ph 3 | active not recruiting | Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis |
| NCT00676715 results posted | ACT4422g 2007-006338-32, WA21493 | Ph 2 | completed | A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis |
| NCT04315948 DisCoVeRy | C20-15 101015736, 2020-000936-23 | Ph 3 | completed | Trial of Treatments for COVID-19 in Hospitalized Adults |
| NCT05936229 | RG1123521 NCI-2023-04888, 20021 | Ph 1, Ph 2 | withdrawn | Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy |
| NCT02735707 REMAP-CAP | U1111-1189-1653 2015-002340-14, 602525 | Ph 3 | recruiting | Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia |
| NCT06019130 NPC-Nivo | EUCT: 2022-500676-59-00 | Ph 2 | recruiting | Nivolumab in Children and Adults With Nasopharyngeal Carcinoma |
| NCT04183491 results posted | SCR-008 | Ph 1 | completed | Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products |
| NCT01412333 results posted | WA21093 2010-020315-36 | Ph 3 | completed | A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis |
| NCT01247324 results posted | WA21092 2010-020337-99 | Ph 3 | completed | A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis |
| NCT03570359 | SG015 2017-003679-75 | Ph 2 | completed | A Study to Test a Potential New Treatment for COPD Patients Suffering From the Common Cold or Influenza |
| NCT04492475 results posted | 20-0006 ACTT-3 | Ph 3 | completed | Adaptive COVID-19 Treatment Trial 3 (ACTT-3) |
| NCT02047734 RADIANCE results posted | RPC01-201-PartB 2012-002714-40 | Ph 3 | completed | Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis |
| NCT03119701 INFORAAA results posted | FP1CLI006 2014-000899-25 | Ph 2 | terminated | Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Prevention of Multi-Organ Failure on Patients After Open Surgery for a RAAA |
| NCT02294058 SUNBEAM results posted | RPC01-301 2014-002320-27 | Ph 3 | completed | Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS) |
| NCT03177083 PLENO | PRT-PEG-15-10880 2016-000434-21 | Ph 4 | completed | Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy |
| NCT04343768 COVIFERON | Different Interferons in COVID | Ph 2 | completed | An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial |
| NCT02622724 INTEREST results posted | FPCLI002 2014-005260-15 | Ph 3 | terminated | Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS) |
| NCT03614715 | MC-CINNA-PKPD-01 2016-000139-41 | Ph 1 | completed | Pharmacokinetics and Pharmacodynamics of CinnoVex (Interferon Beta-1a) Compared to Avonex (Interferon Beta-1a) |
| NCT01119677 | 108HV103 | Ph 1 | completed | A Study of Avonex to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy Volunteers |
| NCT01864148 SYNERGY results posted | 215MS201 2011-006262-40 | Ph 2 | completed | Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex |
| NCT02359877 results posted | BCD-054-1 | Ph 1 | completed | Open Label Study of Tolerability, Pharmacokinetics and Pharmacodynamics of BCD-054 (Pegylated Interferon Beta-1a), IM and SC, Compared to Rebif® and Avonex® in Healthy Volunteers |
| NCT01064401 (DECIDE) results posted | 205MS301 2009-012500-11 | Ph 3 | completed | Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis |
| NCT01766024 results posted | BCD-033-1 | Ph 1 | completed | Pharmacokinetics and Pharmacodynamics Study of BCD-033 Compared to Rebif® in Healthy Volunteers |
| NCT01058005 SURPASS results posted | 101MS325 | Ph 3 | terminated | Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis |
| NCT01181115 Avonex China | 108MS301 | Ph 3 | completed | Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS) |
| NCT01074593 | INTBER0609 VERSION 3 | Ph 1 | completed | Pharmacokinetics and Pharmacodynamics of the Interferon Beta-1a Produced by Laboratorio Quimico Farmaceutico Bergamo Compared to Interferon Beta-1a (Rebif - Merck Serono) in Healthy Subjects |
| NCT01416207 | 108HV105 | Ph 1 | completed | A Multiple-Dose, Open-Label, Phase 1, Pharmacokinetic, Pharmacodynamic, and Safety Study of Avonex® in Chinese Healthy Volunteer Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AVONEX FDA Label Details
Indications & Usage
FDA Label (PDF)AVONEX is indicated for the treatment of Multiple Sclerosis.
Pro Intelligence Preview
Deep insights for AVONEX
Revenue Insights
- • Q4-2025: $180M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2003
- • Generic/biosimilar risk
Trial Analysis
- • 37 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment