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Deuruxolitinib is available as one strength and formulation:
8 mg oral tablet — taken twice daily (BID), with or without food
There is only one approved dose; the 12 mg strength was evaluated in clinical trials but is not approved by the FDA.

Deuruxolitinib is indicated for the treatment of adults with severe alopecia areata (AA). Alopecia areata is an autoimmune condition in which the immune system mistakenly attacks hair follicles, causing partial or complete hair loss on the scalp and body. Severe alopecia areata is defined as 50% or more scalp hair loss.

Deuruxolitinib was FDA-approved on July 25, 2024, and commercially launched in the United States in July 2025. The safety and effectiveness of Deuruxolitinib have not been established in pediatric patients.

Deuruxolitinib is a selective oral Janus kinase (JAK) inhibitor that targets the JAK1 and JAK2 pathways. In alopecia areata, the immune system becomes overactive and attacks hair follicles, disrupting the normal hair growth cycle.

JAK enzymes are proteins that transmit signals responsible for immune activation and inflammation. By binding to and inhibiting JAK1 and JAK2, Deuruxolitinib blocks this overactive immune response, reducing inflammation of the hair follicle and allowing hair to regrow. This treats the condition at its source rather than simply addressing symptoms on the surface.

The recommended dose of Deuruxolitinib is 8 mg taken orally twice daily, with or without food. If a dose is missed, skip that dose and resume at the next scheduled time — do not take two doses at once.
Before starting Deuruxolitinib, your doctor must carry out the following pre-treatment assessments:
CYP2C9 genotype testing — to confirm you are not a poor metabolizer of this enzyme (see safety section)
Check for use of moderate or strong CYP2C9 inhibitors — Deuruxolitinib is contraindicated with these drugs
Complete blood count (CBC) — treatment is not recommended if absolute lymphocyte count is below 500 cells/mm³, absolute neutrophil count below 1,000 cells/mm³, or hemoglobin below 8 g/dL
Tuberculosis (TB) screening — active TB must be treated before starting Deuruxolitinib
Vaccinations — complete any required immunisations, including for herpes zoster, before starting treatment
Deuruxolitinib is dispensed through specialty pharmacy. Your doctor’s office will coordinate access through the Deuruxolitinib Support programme.

Deuruxolitinib carries an FDA Boxed Warning — the most serious type of safety warning. It is important to discuss all risks and benefits with your doctor before starting treatment.
Deuruxolitinib should not be used if you:
Are a CYP2C9 poor metabolizer (a genetic variant affecting how your body processes the drug)
Are currently taking moderate or strong CYP2C9 inhibitors
Have an active, untreated infection
Have severely impaired kidney function (eGFR < 30 mL/min) — not recommended Use with caution and discuss with your doctor if you: Are aged 50 or over with one or more cardiovascular risk factors (high blood pressure, high cholesterol, diabetes) Have a history of blood clots, heart disease, or stroke Are immunocompromised, have diabetes, or chronic lung disease Are pregnant, planning to become pregnant, or breastfeeding — deuruxolitinib may cause fetal harm

The most common side effects of Deuruxolitinib (occurring in 1% or more of patients in clinical trials) include:
Headache (12.4%)
Acne or acneiform dermatitis (10%)
Nasopharyngitis — congestion, sore throat, or cold-like symptoms (8.1%)
Elevated blood creatine phosphokinase (CPK) — a muscle enzyme marker (5.3%)
Hyperlipidaemia — increased cholesterol and/or triglycerides
Fatigue, tiredness, or drowsiness
Weight gain
Lymphopenia — low white blood cell count
Thrombocytosis — elevated platelet count
Anaemia — low red blood cell count
Skin and soft tissue infections (e.g. folliculitis, impetigo)
Neutropenia — low neutrophil count
Herpes virus reactivation (including shingles/herpes zoster)
Your doctor will monitor you with regular blood tests before and during treatment to check lipid levels, blood cell counts, and other parameters.

Deuruxolitinib carries a Boxed Warning for the following serious risks. Contact your healthcare provider immediately — or seek emergency help — if you experience any of the following:
Serious infections: Deuruxolitinib suppresses your immune system. Bacterial, fungal, and viral infections — including TB, fungal infections, and opportunistic infections — have occurred and can be life-threatening
Cardiovascular events: increased risk of heart attack, stroke, and cardiovascular death, particularly in those aged 50+ with existing heart disease risk factors
Blood clots (thrombosis): including deep vein thrombosis (DVT), pulmonary embolism (PE), and cerebral venous sinus thrombosis (CVST). Seek emergency care immediately if you experience chest pain, sudden shortness of breath, leg swelling, or sudden severe headache
Malignancies (cancers): including lymphoma and other cancers have been observed with JAK inhibitor therapy. Risk may be higher in current or past smokers
Gastrointestinal perforations: tears in the stomach or intestines — seek emergency care if you have severe stomach pain or changes in bowel habits
Increased risk of mortality: JAK inhibitors have been associated with increased risk of death in patients aged 50+ with at least one heart disease risk factor
Laboratory abnormalities: changes in blood counts, lipid levels, and creatine phosphokinase levels require monitoring

Several important drug interactions apply to Deuruxolitinib:
Moderate or strong CYP2C9 inhibitors: Deuruxolitinib is contraindicated with these. Always inform your doctor and pharmacist of all medications you take
Other JAK inhibitors: Deuruxolitinib should not be combined with other JAK inhibitors
Biologic immunomodulators: concomitant use is not recommended
Cyclosporine or other potent immunosuppressants: use alongside Deuruxolitinib is not recommended
Live vaccines: do not receive any live vaccines immediately before or during Deuruxolitinib treatment
A unique requirement for Deuruxolitinib is CYP2C9 genetic testing before starting. Sun Pharma covers the cost of this genotyping test through LabCorp or Quest as part of the Deuruxolitinib Support programme.
Always inform your doctor and pharmacist of all medications, supplements, vitamins, and herbal products you are taking before starting Deuruxolitinib.

Various FDA-approved generic manufacturers

No. Deuruxolitinib may cause fetal harm and should not be used during pregnancy. Based on animal studies, Deuruxolitinib has been associated with reduced fetal weight, skeletal malformations, decreased pup survival, and adverse effects on reproductive outcomes in offspring.
Women of reproductive potential should use effective contraception during treatment and for a recommended period after stopping. Patients who become pregnant while taking Deuruxolitinib should notify their healthcare provider immediately. Pregnancy exposures should be reported to Sun Pharmaceutical Industries, Inc. at 1-800-818-4555.
It is not known whether Deuruxolitinib passes into human breast milk. Given the potential for harm to a breastfed infant, breastfeeding is not recommended during treatment.

• Leqselvi