Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2420 |
| INN | Fasinumab |
| Status | Terminated |
| Drug code(s) | REGN475/SAR164877, MT-5547 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (VelocImmune) |
| Target(s) | NGF |
| Indications of clinical studies | Pain due to Osteoarthritis of the Knee or Hip Pain (Phase 3), low back pain (Phase 2/3) |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | February 15, 2009 |
| Start of Phase 2 | November 15, 2009 |
| Start of Phase 3 | May 15, 2015 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Regeneron Pharmaceuticals |
| Licensee/Partner | Teva, Mitsubishi Tanabe Pharma Corporation |
| Comments about company or candidate | Q3 2022 update: Regeneron discontinued (i) further clinical development of fasinumab, an antibody to NGF, which was previously being studied in osteoarthritis pain of the knee or hip in collaboration with Teva and Mitsubishi Tanabe Pharma; and (ii) the Phase 3 study of REGN1908-1909, a multi-antibody therapy to Fel d 1, in cat allergy, due to futility. Aug 2022: Still listed in pipeline, but not listed as possible submission in Regeneron update. All studies listed on clinicaltrials.gov are complete, withdrawn or terminated as of March 2022. May 2021: Regeneron plans regulatory submission in osteoarthritis pain in 2021; https://investor.regeneron.com/static-files/e90481f9-321f-4a55-804e-1d6ce4557112 Feb 2020: Teva announced Fasinumab for chronic lower back pain has been put on hold. NCT03491904 Phase 3 study started in January 2010; NCT03161093 Phase 3 study in Osteoarthritis of the knee or hip. started in Sep 2017. Oct 17, 2016: Regeneron and Teva plan to design a pivotal Phase 3 study in chronic low back pain that excludes patients with advanced osteoarthritis. The companies plan to submit a pivotal program plan for review with the FDA and other health authorities. Sept. 20, 2016: Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today a global 1 agreement to develop and commercialize fasinumab. May 2, 2016: Primary endpoint met in placebo-controlled Phase 2/3 study evaluating fasinumab in patients with moderate-to-severe osteoarthritis pain of the hip or knee who have a history of inadequate pain relief or intolerance to current analgesic therapies NCT02447276 Phase 2/3 started in May 2015. Mitsubishi Tanabe has exclusive development and commercial rights to fasinumab (REGN475), Regeneron's NGF antibody in late-stage development for musculoskeletal pain. Under the terms of the agreement, MTPC will obtain exclusive development and commercial rights to fasinumab in Japan, Korea and nine other Asian countries, excluding China. |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
S228P stabilized
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |