Interferon beta-1b
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | BETASERON | — | 2003-03-14 – 2017-05-26 | fda.gov ↗ |
| Approved | EU (EMA) | Betaferon | — | 1995-11-30 | europa.eu ↗ |
| Approved | US (FDA) | BETASERON | — | 1993-07-23 | fda.gov ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02474134 | Mar → Oct 2015 | multiple sclerosis | Pfenex, Inc | Completed | No outcome recorded |
| Phase 1 | NCT00000695 | ? → Jul 1991 | HIV infectious disease, Kaposi's sarcoma | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 27 trials · 2 met primary | ||||||
| Phase 2 | NCT04647695 | Nov 2020 → Jul 2021 | COVID-19 | The University of Hong Kong | Unknown | Met primary |
| Phase 2 | NCT04465695 | Jul 2020 → Jun 2021 | COVID-19 | The University of Hong Kong | Unknown | No outcome recorded |
| Phase 2 | NCT04343768 | Apr 2020 | COVID-19 | Shahid Beheshti University of Medical Sciences | Completed | Met primary |
| Phase 2 | NCT00235989 | Jun 2003 → Jan 2008 | relapsing-remitting multiple sclerosis | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00298662 | Feb 2003 → Sep 2006 | multiple sclerosis | Clinique de sclérose en plaques et neuromusculaire de l'Outaouais | Unknown | No outcome recorded |
| Phase 2 | NCT00185250 | Dec 2002 → Nov 2005 | cardiomyopathy | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT00893217 | Nov 2002 → Jun 2003 | relapsing-remitting multiple sclerosis | Bayer | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT02845843 | Jul 2016 → May 2020 | Middle East respiratory syndrome | King Abdullah International Medical Research Center | Completed | Met primary |
| Phase 36 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT00459667 | May 2007 → Mar 2008 | relapsing-remitting multiple sclerosis | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00370071 | Nov 2006 → Sep 2008 | multiple sclerosis | Bayer | Completed | Met primary |
| Phase 3 | NCT00099502 | Nov 2003 → Aug 2007 | relapsing-remitting multiple sclerosis | Bayer | Completed | Missed primary |
| Phase 3 | NCT00185211 | Aug 2002 → May 2008 | multiple sclerosis | Bayer | Completed | Mixed |
| Phase 3 | NCT00313976 | — | multiple sclerosis | Bayer | Withdrawn | No outcome recorded |
| Phase 3 | NCT00002238 | — | HIV infectious disease | Bayer | Completed | No outcome recorded |
| Phase 45 trials · 1 met primary | ||||||
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Phase 4 | NCT01701856 | Sep 2012 → Oct 2013 | relapsing-remitting multiple sclerosis | Claudio Gobbi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01216072 | Aug 2010 → Aug 2012 | multiple sclerosis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT01144052 | Jun 2010 → Nov 2011 | relapsing-remitting multiple sclerosis | Claudio Gobbi | Completed | No outcome recorded |
| Phase 4 | NCT00317941 | Mar 2006 → Apr 2008 | relapsing-remitting multiple sclerosis | Bayer | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00002299 | — | HIV infectious disease, cytomegalovirus retinitis | Hoffmann-La Roche | Completed | No outcome recorded |
| Comparator or background therapy19 trials | ||||||
| Phase 2 | NCT04494399 Comparator | Jul 2020 → Jul 2022 | COVID-19 | The University of Hong Kong | Unknown | No outcome recorded |
| Phase 2 | NCT04350281 Comparator | Apr → Jul 2020 | COVID-19 | The University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT04276688 Comparator | Feb → Mar 2020 | COVID-19 | The University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT00489489 Background | May 2007 → Jun 2009 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT01111656 Background | Mar 2007 → Apr 2010 | relapsing-remitting multiple sclerosis | Insel Gruppe AG, University Hospital Bern | Completed | Missed primary |
| Phase 2 | NCT00436826 Background | Nov 2006 → Sep 2011 | multiple sclerosis | EMD Serono Research & Development Institute, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00273364 Comparator | Nov 2005 → Jan 2017 | multiple sclerosis | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT00942591 Background | May 2005 → Apr 2009 | relapsing-remitting multiple sclerosis | Insel Gruppe AG, University Hospital Bern | Completed | No outcome recorded |
| Phase 2/3 | NCT01647880 Comparator | Jul 2013 → Apr 2016 | multiple sclerosis | Charite University, Berlin, Germany | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT00428584 Comparator | Dec 2006 → Nov 2007 | relapsing-remitting multiple sclerosis | EMD Serono | Completed | Missed primary |
| Phase 4 | NCT03177083 Comparator | Jan 2017 → Oct 2020 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT02234869 Comparator | Oct 2014 → Feb 2017 | multiple sclerosis | Biogen | Withdrawn | No outcome recorded |
| Phase 4 | NCT01623596 Comparator | Jun 2012 → Jul 2015 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01317004 Comparator | May 2011 → Jun 2014 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01333501 Comparator | May 2011 → Sep 2015 | multiple sclerosis | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 4 | NCT00780455 Background | Oct 2008 → Sep 2009 | relapsing-remitting multiple sclerosis | Bayer | Terminated | No outcome recorded |
| Phase 4 | NCT00202995 Comparator | Jul 2004 → Oct 2007 | relapsing-remitting multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00206648 Comparator | Mar 2003 → Oct 2005 | relapsing-remitting multiple sclerosis | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00176592 Comparator | Jan 2003 → Jan 2007 | multiple sclerosis | University of Medicine and Dentistry of New Jersey | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2008-04-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Copaxone® Significantly Reduced Annual Relapse Rates And Stabilized Disease Progression In Relapsing Remitting Multiple Sclerosis Patients Failing Interferon Treatment tevapharm.com ↗
Whereas the proportion of relapse-free patients switching from one IFNβ to another IFNβ remained similar before and after switch. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2008-04-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Copaxone® Significantly Reduced Annual Relapse Rates And Stabilized Disease Progression In Relapsing Remitting Multiple Sclerosis Patients Failing Interferon Treatment tevapharm.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 49 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Interferon beta-1b | “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗32“The purpose of this study is to compare the safety, tolerability, and blood levels of two interferon beta-1b products, Betaferon and PF530, in healthy volunteers.” NCT02474134 ↗ “selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.” NCT01216072 ↗ “Interferon beta 1a or interferon beta 1b or Glatiramer Acetate” NCT01317004 ↗ “Reference product: Interferon-beta-1b 250mg given” NCT00942591 ↗ “Betaseron (Interferon beta-1b, BAY86-5046)” NCT00893217 ↗ “Interferon beta-1b (Extavia®)” NCT01647880 ↗ “Drug: Interferon beta 1b” NCT00942591 ↗ |
| Known as | BAY86-5046 | “Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization” NCT00780455 ↗6“Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)” NCT00313976 ↗ “Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)” NCT00185250 ↗ “Drug: Interferon beta-1b (Betaseron, BAY86-5046)” NCT00185211 ↗ “Interferon beta 1b (Betaseron, BAY86-5046)” NCT00235989 ↗ “Betaseron (Interferon beta-1b, BAY86-5046)” NCT00893217 ↗ “Interferon beta-1b (Betaseron, BAY86-5046)” NCT00370071 ↗ |
| Known as | Betaferon | “Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase” NCT00185211 ↗7“BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose” NCT00459667 ↗ “Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)” NCT00185250 ↗ “Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)” NCT00313976 ↗ “Rebif or Betaseron/Betaferon” NCT02234869 ↗ “Betaferon/Betaseron” NCT00206648 ↗ |
| Known as | Betaseron | “Participants received IFN-beta therapy (Rebif® new formulation \[RNF\] 44 microgram \[mcg\] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or...” NCT00436826 ↗19“Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗ “To evaluate the safety and efficacy of interferon beta (Betaseron) in AIDS and advanced AIDS related complex (ARC) patients receiving a reduced-dose zidovudine (AZT) regimen.” NCT00002238 ↗ “Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization” NCT00780455 ↗ “Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.” NCT00428584 ↗ “Interferon Beta preparation (Exctavia, Betaseron, Rebif, Avonex)” NCT01623596 ↗ “interferon beta 1-b (Betaseron®) and tacrolimus (Prograf®)” NCT00298662 ↗ “Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)” NCT00185250 ↗ “Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)” NCT00313976 ↗ “Drug: Interferon beta-1b (Betaseron, BAY86-5046)” NCT00185211 ↗ “Interferon beta 1b (Betaseron, BAY86-5046)” NCT00235989 ↗ |
| Known as | Betaseron (beta interferon) | “Betaseron (beta interferon)” NCT03535298 ↗ |
| Known as | Extavia | “Interferon beta-1b (Extavia®)” NCT01647880 ↗1“Extavia (beta interferon)” NCT03535298 ↗ |
| Known as | Extavia (beta interferon) | “Extavia (beta interferon)” NCT03535298 ↗ |
| Known as | IFNB | “switched to subcutaneous interferon 1b (IFNB) treatment.” PMID 23915113 ↗ Aug 2013 |
| Known as | IFNB-1b | “OBJECTIVES: To report the 12-month extension of a phase II trial evaluating the efficacy, safety and tolerability of atorvastatin 40 mg/d added to interferon beta-1b (IFNB-1b)...” PMID 24497963 ↗ Jan 20142“The aim of this study was to evaluate satisfaction and adherence to treatment, behavioral and fatigue changes in patients switched to IFN B 1B compared to continued NTZ treatment.” PMID 24576156 ↗ Feb 2014 “Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase” NCT00185211 ↗ |
| Known as | IFNβ-1b | “Patients with acute unilateral ON, occurring as a clinically isolated syndrome or MS relapse, were randomized to 6 months of treatment with 0.5 mg oral fingolimod or...” PMID 32126977 ↗ Mar 20203“Eligible patients aged 18-60 years were randomized to receive either IFNβ-1a, titrated to 44 μg sc three times weekly (tiw) (n = 65), or IFNβ-1b, titrated to 250 μg sc every...” PMID 23216674 ↗ Dec 2012 “OBJECTIVE: To determine the frequency and consequences of neutralizing antibodies (NAbs) in patients with a first event suggestive of multiple sclerosis (MS) treated with...” PMID 21849647 ↗ Aug 2011 “Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV.” PMID 29382391 ↗ Jan 2018 |
| Known as | interferon 1b | “switched to subcutaneous interferon 1b (IFNB) treatment.” PMID 23915113 ↗ Aug 2013 |
| Known as | interferon β-1b | “Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV.” PMID 29382391 ↗ Jan 20182“a 5-day course of subcutaneous injection of interferon β-1b 2mL (16 million IU) consecutively” NCT04647695 ↗ “Subcutaneous injection of interferon β-1b 1mL (0.5mg; 16 million IU) for 3 days” NCT04465695 ↗ |
| Known as | Ziferon | “Interferon-β 1b (Ziferon)” PMID 32493468 ↗ Jun 2020 |
| Modality | Protein / enzyme biologic | “Interferon beta 1b” NCT00317941 ↗ |
| Route | Subcutaneous | “Patients then receive IFN-B subcutaneously once a day” NCT00000695 ↗ |