Last reviewed 2026-04-20 · How we verify

Leqselvi (DEURUXOLITINIB)

Deuruxolitinib inhibits JAK1, JAK2, and TYK2, modulating cytokine and growth factor signaling involved in hematopoiesis and immune function.

At a glance

Mechanism of action

Deuruxolitinib works by blocking the activity of JAK1, JAK2, and TYK2, which are enzymes that help transmit signals from cytokines and growth factors. This inhibition affects the signaling pathways that control blood cell production and immune responses, potentially reducing inflammation and other disease processes.

Approved indications

• severe alopecia areata

Boxed warnings

• WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS Increased risk of serious bacterial, fungal, viral and opportunistic infections, including tuberculosis (TB), that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. LEQSELVI treatment is not recommended in patients with active tuberculosis. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death, was observed with another Janus kinase (JAK) inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. ( 5.2 ) Malignancies were reported in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) Higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.4 ) Thrombosis, including cerebral venous sinus thrombosis (CVT), deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers. ( 5.5 ) WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) and THROMBOSIS See full prescribing information for complete boxed warning. Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB), that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. ( 5.2 ) Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. ( 5.4 ) Thrombosis has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. ( 5.5 )

Common side effects

• Acne
• Headache
• Nasopharyngitis
• Blood creatine phosphokinase increased
• Hyperlipidemia
• Fatigue
• Skin and soft tissue infections
• Anemia
• Weight increased
• Neutropenia
• Lymphopenia
• Thrombocytosis

Drug interactions

• Strong CYP3A and moderate or strong CYP2C9 inducers
• Moderate or strong CYP2C9 inhibitors
• Strong CYP3A4 and moderate or strong CYP2C9 inducers
• Moderate or strong CYP2C9 inhibitors

Key clinical trials

• Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2) (PHASE3)
• Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA1) (PHASE3)
• Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata (PHASE3)
• Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543 (PHASE1)
• Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543 (PHASE1)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Leqselvi CI brief — competitive landscape report
• Leqselvi updates RSS · CI watch RSS
• Sun Pharm Inds Inc portfolio CI