Drugs / Fasinumab
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03491904 | Jan 2019 → Jan 2020 | osteoarthritis, hip, osteoarthritis, knee | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02516618 | Jul 2015 → Feb 2016 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00944892 | Aug 2009 → May 2010 | osteoarthritis, knee | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 26 trials · 1 missed | ||||||
| Phase 2 | NCT03949673 | Apr 2019 → Aug 2020 | osteoarthritis, hip, osteoarthritis, knee | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03691974 | Oct 2018 → Jan 2020 | osteoarthritis, hip, osteoarthritis, knee | Regeneron Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT01001923 | Dec 2009 → Jan 2011 | — | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01001715 | Nov 2009 → Jan 2011 | — | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00991172 | Nov 2009 → May 2010 | sciatica | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01239017 | — | osteoarthritis | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT02620020 | Jan 2016 → Feb 2017 | — | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 2/3 | NCT02447276 | May 2015 → Mar 2016 | osteoarthritis, hip, osteoarthritis, knee | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT03285646 | Oct 2017 → May 2018 | chronic pain syndrome, osteoarthritis | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03304379 | Oct 2017 → Dec 2019 | osteoarthritis, hip, osteoarthritis, knee | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03161093 | Aug 2017 → Sep 2019 | osteoarthritis, hip, osteoarthritis, knee | Regeneron Pharmaceuticals | Completed | Mixed |
| Phase 3 | NCT02683239 | Feb 2016 → Dec 2020 | osteoarthritis | Regeneron Pharmaceuticals | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT00856310 Comparator | Feb → Nov 2009 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2020-08-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Reports Second Quarter 2020 Financial Results tevapharm.com ↗
Results for two phase 3 clinical trials, FACT OA1 and FACT OA2, were released on August 5, 2020, indicating that the co-primary endpoints for fasinumab were achieved. |
| 2018-08-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva and Regeneron Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip tevapharm.com ↗
At the week 16 primary efficacy analysis, the study met both co-primary endpoints and all key secondary endpoints. |
| 2018-08-16 | Regeneron Pharmaceuticals | Results Regeneron and Teva Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip. |
| 2016-10-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Regeneron and Teva Provide Update on Fasinumab Clinical Development Programs tevapharm.com ↗
As a result of the FDA decision, Regeneron completed an unplanned interim review of results and has stopped dosing in the study. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-08-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Reports Second Quarter 2020 Financial Results tevapharm.com ↗ |
| 2018-08-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Regeneron Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip tevapharm.com ↗ |
| 2018-08-16 | Regeneron Pharmaceuticals | Regeneron and Teva Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip regeneron.com ↗ |
| 2016-10-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regeneron and Teva Provide Update on Fasinumab Clinical Development Programs tevapharm.com ↗ |
| 2016-09-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Regeneron Announce Global Collaboration to Develop and Commercialize Fasinumab, an Investigational NGF Antibody for Chronic Pain tevapharm.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fasinumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03949673 ↗ |
| Known as | REGN475 | “Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Vertebral Fracture Associated With Osteoporosis” NCT01001715 ↗ |
| Known as | SAR164877 | “Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Chronic Pancreatitis” NCT01001923 ↗3“A Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Osteoarthritis of the Knee” NCT00944892 ↗ “REGN475 (SAR164877)” NCT00856310 ↗ |
| Action | Inhibit | “Nerve growth factor inhibitors (eg, fasinumab) can reduce pain” PMID 41323020 ↗ Oct 20251“Beta-nerve growth factor inhibitor” CHEMBL2109528 ↗ |
| Modality | Monoclonal antibody | “fasinumab, an anti-nerve growth factor monoclonal antibody” PMID 31207169 ↗ Sep 2019 |
| Route | Intravenous | “intravenously administered REGN475” NCT00856310 ↗ |
| Target | NGF | “Beta-nerve growth factor inhibitor” CHEMBL2109528 ↗ |