Chemistry:Brepocitinib
Brepocitinib, sold under the brand name Lisraya, is a medication used for the treatment of dermatomyositis.[1] It is a Janus kinase and tyrosine kinase 2 inhibitor.[1] It is taken by mouth.[1]
The most common adverse reactions include upper respiratory tract infection, headache, fatigue, urinary tract infection, and nausea.[2]
Brepocitinib was approved for medical use in the United States in August 2026.[2]
Medical uses
Brepocitinib is indicated for the treatment of dermatomyositis in adults.[1]
Dermatomyositis is a rare autoimmune disease in which the immune system attacks the muscles and skin, causing chronic inflammation, progressive muscle weakness, and distinctive skin rashes.[2]
History
The efficacy and safety of brepocitinib were evaluated in a phase III randomized, double-blind, multi-center, placebo-controlled study (NCT05437263) that included 241 adults with dermatomyositis.[2] Participants were randomized to receive brepocitinib 30 mg once daily, brepocitinib 15 mg once daily or placebo for a 52-week treatment period.[2]
Society and culture
Legal status
Brepocitinib was approved for medical use in the United States in August 2026.[3] The US Food and Drug Administration (FDA) granted the application for brepocitinib orphan drug and priority review designations.[2] The FDA granted the approval of Lisraya to Priovant Therapeutics.[2]
Names
Brepocitinib is the international nonproprietary name.[4]
Brepocitinib is sold under the brand name Lisraya.[3]
References
- ↑ 1.0 1.1 1.2 1.3 Cite error: Invalid
<ref>tag; no text was provided for refs namedLisraya FDA label - ↑ 2.0 2.1 2.2 2.3 2.4 2.5 2.6 "FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults". U.S. Food and Drug Administration (FDA). 27 August 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults.
This article incorporates text from this source, which is in the public domain.
- ↑ 3.0 3.1 "Roivant Announces FDA Approval of Lisraya (brepocitinib) for Adults with Dermatomyositis; Now Available in the U.S." (Press release). Roivant Sciences. 27 August 2026. Retrieved 31 August 2026.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information 34 (1). 2020.
Further reading
- "Recent developments for new investigational JAK inhibitors in psoriatic arthritis". Expert Opinion on Investigational Drugs 32 (5): 361–371. May 2023. doi:10.1080/13543784.2023.2207737. PMID 37096862.
- "Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841)". Journal of Medicinal Chemistry 61 (19): 8597–8612. October 2018. doi:10.1021/acs.jmedchem.8b00917. PMID 30113844.
- "TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial". The Journal of Investigative Dermatology 140 (12): 2359–2370.e5. December 2020. doi:10.1016/j.jid.2020.03.962. PMID 32311398.
- "Novel Therapies in Plaque Psoriasis: A Review of Tyrosine Kinase 2 Inhibitors". Dermatology and Therapy 13 (2): 417–435. February 2023. doi:10.1007/s13555-022-00878-9. PMID 36592300.
External links
- "Brepocitinib ( Code - C161798 )". https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C161798.
- "Brepocitinib Tosylate ( Code - C171779 )". https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C171779.
- Clinical trial number NCT05437263 for "A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis (VALOR)" at ClinicalTrials.gov
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