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MedsAcross

Molecule

Brepocitinib

Also known as brepocitinib tosylate
Available on requestOrphan
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Brepocitinib is a prescription medicine indicated for the treatment of dermatomyositis in adult patients. It is available as tablets for oral use. MedsAcross supplies Brepocitinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

US FDA first approval
27 August 2026
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 3X8387Q25NDrugBank DB15003Q76854294

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

LISRAYA is indicated for the treatment of dermatomyositis in adult patients. LISRAYA is a Janus kinase (JAK) and tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of dermatomyositis in adult patients. Limitations of Use LISRAYA is not recommended for use in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.

Source: US FDA prescribing information

How it works

Brepocitinib is a Janus kinase (JAK) and tyrosine kinase 2 (TYK2) inhibitor. In a cell-free isolated enzyme assay, brepocitinib had greater inhibitory potency at TYK2 and JAK1 than JAK2 (≥ 3.4-fold) and JAK3 (≥ 286-fold). The JAK family comprises cytoplasmic tyrosine kinases that mediate signal transduction of cytokine receptors to influence immune cell function. Within the signaling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs) which modulate intracellular activity including gene expression. JAKs mediate cytokine signaling through hetero- or homodimeric pairing. In human cellular assays, brepocitinib inhibited signaling of TYK2- and JAK1-mediated cytokine-induced STAT phosphorylation, including signaling of TYK2/JAK1, TYK2/JAK2, JAK1/JAK3, and TYK2/JAK1/JAK2.

Source: US FDA prescribing information

Dosing overview

Prior to LISRAYA treatment initiation, consider performing active and latent tuberculosis (TB) infection evaluation, viral hepatitis screening, a complete blood count, baseline hepatic and renal function tests, verifying pregnancy status, and updating immunizations. Avoid LISRAYA treatment in patients with active hepatitis B or hepatitis C, an absolute lymphocyte count less than 500 cells/mm 3, absolute neutrophil count less than 1,000 cells/mm 3, or hemoglobin level less than 8 g/dL. The recommended dosage is 30 mg once daily, administered orally with or without food. See Full Prescribing Information for recommended dosage interruption due to laboratory abnormalities.

Source: US FDA prescribing information

Contraindications

LISRAYA is contraindicated in patients with a history of hypersensitivity reactions to brepocitinib or any of the excipients in LISRAYA.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis serious infections): Patients treated with LISRAYA are at increased risk of developing serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death. Serious Infections: Avoid use of LISRAYA during an active serious infection, including localized infections. Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported. Discontinue LISRAYA if a clinically significant hypersensitivity reaction occurs. Gastrointestinal (GI) Perforations: Monitor patients at risk for GI perforations and promptly evaluate patients with symptoms. Hypoglycemia in Patients with Diabetes: Consider increased monitoring of blood glucose.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections Mortality Malignancy and Lymphoproliferative Disorders Major Adverse Cardiovascular Events (MACE) Thrombosis Hypersensitivity Reactions Gastrointestinal Perforations Hypoglycemia in Patients with Diabetes Laboratory Abnormalities Most common adverse reactions (≥ 5% with LISRAYA and ≥ 2% greater than placebo) are upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, fall, influenza, and acne.

Source: US FDA prescribing information

Interactions

Effects of Other Drugs on LISRAYA Smoking Smoking causes induction of CYP1A1 and CYP1A2 levels. The exposure of brepocitinib in current smokers is lower than in non-current smokers, and therefore, the effectiveness of LISRAYA may be reduced in smokers.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Brepocitinib, sorted by availability.

MedicineManufacturerRegisterAvailability
Lisraya 30 mg tabletOralPriovant TherapeuticsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 27 August 2026Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Brepocitinib available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Brepocitinib and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Brepocitinib have?

The catalogue lists 1 brand names for Brepocitinib, including Lisraya.

Is Brepocitinib approved by the US FDA?

Yes. The US FDA first approved Brepocitinib on 27 August 2026, according to Drugs@FDA.

Does Brepocitinib need cold chain shipping?

No listed presentation of Brepocitinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. LISRAYA prescribing information (Priovant Therapeutics). U.S. National Library of Medicine, DailyMed. Retrieved 5 November 2026

Request Brepocitinib for export supply

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