interferon beta-1b
Trade name: betaseron
Recombinant proteinapprovedOrphan Drug FDA
Approved
Jul 23, 1993
Interferon beta-1b is a cytokine in the interferon family used to treat the relapsing-remitting and secondary-progressive forms of multiple sclerosis (MS). It is approved for use after the first MS event. Closely related is interferon beta 1a, also indicated for MS, with a very similar drug profile. — Wikipedia
Clinical trial activity
141 trials · 88 clinical orgs · 4 marketing orgs
Phase 1
18
Phase 2
78
Phase 3
45
Phase 4
37
Earliest trial started Sep 1, 1998 (NCT00001785)
Timeline
1980s
- Nov 17, 1988
Orphan Drug Designation
1990s
- Jul 23, 1993
Bayer — Earliest FDA Approval
- Jul 23, 1993
Bayer — Marketing Organization
- Jul 23, 1993
Bayer — NDA Secondary Org
- Jul 23, 1993
Bayer — NDA Organization
- May 17, 1996
Biogen — Marketing Organization
- Jan 1, 1998
Earliest Phase 2 Sponsor(trial)
- Jan 1, 1999
Earliest Phase 1 Sponsor(trial)
- Jan 1, 1999
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Studied for
- Alzheimer Disease · Phase 2
- Asthma · Phase 2
- Cardiomyopathies · Phase 2
- Cerebellar Diseases · Phase 4
- Colitis, Ulcerative · Phase 2
- COVID-19 · Phase 4
- Crohn Disease · Phase 2
- Demyelinating Diseases · Phase 4
- Fallopian Tube Neoplasms · Phase 1
- Hamartoma · Phase 1
- Healthy Volunteers · Phase 1
- Heart Diseases · Phase 2
- Hepatitis B · Phase 2
- Hepatitis C · Phase 3
- HIV Infections · Phase 3
- HTLV-I Infections · Phase 2
- Lung Diseases · Phase 2/Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 4
- Multiple Organ Failure · Phase 2
- Multiple Sclerosis, Relapsing-Remitting · Phase 4
- Myelitis · Phase 4
- Myelitis, Transverse · Phase 4
- Neuritis · Phase 4
- Optic Neuritis · Phase 4
- Osteopetrosis · Phase 2
- Ovarian Neoplasms · Phase 1
- Paraparesis, Tropical Spastic · Phase 2
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Phase 2
- Preventive Medicine · Phase 2
- Psoriasis · Early Phase 1
- Pulmonary Disease, Chronic Obstructive · Phase 2
- Respiratory Distress Syndrome · Phase 3
- Sarcoma, Kaposi · Phase 1
- Spinal Cord Diseases · Phase 2
- Stroke · Phase 1
Mechanism of action
Interferon alpha/beta receptor agonist
Alpha subunit is binding site
- Interferon betaSupplementation
IFNB1 supplementation
Approval history
- approvedAcceleratedJul 23, 1993
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaInterferon beta-1b ↗
- ChEMBLCHEMBL2108510 ↗
- ChEMBLCHEMBL1201564 ↗
- ChEMBLCHEMBL1201563 ↗
- NCATSTTD90R31WZ ↗
Also known as
- actimmune
- actimmune
- actimmune
- actimmune
- betaferon
- betaseron
- betaseron
- betaseron
- betaseron
- extavia
- extavia
- extavia
- immukin
- interf b 1b
- interferon beta 1-a
- interferon beta 1b
- interferon beta-1b
- interferon beta-1b
- interferon beta-1b
- interferon beta-1b
- interferon beta-1b
- interferon beta-1b
- interferon beta-1b
- interferon beta-1b
- interferon beta-1b
- interferon beta-1b
- interferon-beta-1b
- interferon-beta-1b
- interferon beta 1b (recombinant)
- interferon beta-1b,recombinant
- recombinant interferon beta-1b
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04647695 | Phase 2 | Nov 20, 2020 | The University of Hong Kong |
| NCT04494399 | Phase 2 | Jul 29, 2020 | Government of Hong Kong, The University of Hong Kong |
| NCT04465695 | Phase 2 | Jul 14, 2020 | The University of Hong Kong |
| NCT04366245 | Phase 1/Phase 2 (Phase 2) | Apr 23, 2020 | Andalusian Network for Design and Translation of Advanced Therapies |
| NCT04343768 | Phase 4 | Apr 10, 2020 | Shahid Beheshti University of Medical Sciences |
| NCT04350281 | Phase 2 | Apr 9, 2020 | The University of Hong Kong |
| NCT04276688 | Phase 2 | Feb 10, 2020 | Government of Hong Kong, The University of Hong Kong |
| NCT03570359 | Phase 2 | Jan 29, 2018 | Moorgreen Hospital, Southampton, Synairgen Research Ltd. |
| NCT03119701 | Phase 2 | Jan 31, 2017 | Faron Pharmaceuticals Ltd, University of Helsinki, University of Turku |
| NCT03177083 | Phase 4 | Jan 30, 2017 | Biogen |
| NCT02948426 | Phase 1 | Oct 20, 2016 | National Cancer Institute (NCI) |
| NCT02744222 | Phase 2 | Aug 1, 2016 | Biocad |
| NCT02845843 | Phase 2/Phase 3 (Phase 3) | Jul 1, 2016 | King Abdul-Aziz University |
| NCT02584608 | Phase 2 | Jan 1, 2016 | Horizon Pharma, Indiana University |
| NCT02622724 | Phase 3 | Nov 1, 2015 | Faron Pharmaceuticals Ltd, University of London, University of Roma La Sapienza |
| NCT02491684 | Phase 2 | Jul 1, 2015 | AstraZeneca |
| NCT02474134 | Phase 1 | Mar 1, 2015 | IDT Australia Ltd., Pfenex, Inc |
| NCT02364986 | Phase 1 | Jan 1, 2015 | BfARM, Bonn, Deutsches Zentrum für Neurodegenerative Erkrankungen e. V., University of Bonn |
| NCT02254304 | Phase 4 | Dec 1, 2014 | Merck, Merck KGaA |
| NCT02269930 | Phase 1 | Oct 1, 2014 | Biogen |
Showing 20 of 141 trials
Page 1 / 8
Organizations
Research & Development (88)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Biogen | For profit | 32 | 27 | 5 | 1999 |
| Merck Serono | For profit | 25 | 13 | 4 | 1999 |
| Bayer | For profit | 16 | 12 | 3 | 1999 |
| Merck KGaA | For profit | 13 | 13 | 3 | 2004 |
| Novartis | For profit | 6 | 6 | 2 | 2006 |
| Pfizer | For profit | 5 | 0 | 4 | 2003 |
| The University of Hong Kong | Academic/Hospital | 5 | 5 | 1 | 2020 |
| Biocad | For profit | 4 | 4 | 3 | 2013 |
| Roche | For profit | 4 | 3 | 3 | 1999 |
| Biogen-IDEC | For profit | 3 | 0 | 1 | 1999 |
| Genzyme | For profit | 3 | 3 | 2 | 2002 |
| Merck | For profit | 3 | 0 | 3 | 2002 |
| National Institute of Neurological Disorders and Stroke (NINDS) | Government | 3 | 2 | 3 | 1998 |
| Teva | For profit | 3 | 3 | 2 | 2004 |
| University of North Carolina at Chapel Hill | Academic/Hospital | 3 | 3 | 2 | 2004 |
| University of Roma La Sapienza | Academic/Hospital | 3 | 2 | 2 | 2002 |
| BioPartners GmbH | For profit | 2 | 0 | 1 | 2005 |
| Elan Pharmaceuticals | For profit | 2 | 0 | 2 | 2010 |
| Faron Pharmaceuticals Ltd | For profit | 2 | 2 | 2 | 2015 |
| Government of Hong Kong | Government | 2 | 0 | 1 | 2020 |
88 organizations
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