Deuruxolitinib

Deuruxolitinib is a Janus kinase (JAK) inhibitor. JAKs mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function.

• LEQSELVI™ is indicated for the treatment of adult patients with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

• LEQSELVI is contraindicated in patients who: Are CYP2C9 poor metabolizers [see Warnings and Precautions ( 5.6 )] . Are on concomitant moderate or strong CYP2C9 inhibitors [see Warnings and Precautions ( 5.6 )] .contraindicated

For recommended testing, evaluations, and procedures prior to and during LEQSELVI treatment, see Full Prescribing Information. ( 2.1 ) Recommended dosage is 8 mg twice daily. ( 2.2 ) For treatment interruption for certain adverse reactions, see Full Prescribing Information. ( 2.3 ) 2.1 Recommended Evaluations and Immunizations Prior to and During Treatment Perform the following prior to treatment with LEQSELVI: CYP2C9 genotype determination: Test patients for CYP2C9 variants to determine CYP2C9 genotype. LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers (patients with decreased cytochrome P450 (CYP) 2C9 function) [see Contraindications ( 4 )] . An FDA-cleared or -approved test for the detection of CYP2C9 variants to direct the use of LEQSELVI is not currently available. Evaluation for use of concomitant CYP2C9 inhibitors: LEQSELVI is contraindicated in patients taking moderate or strong CYP2C9 inhibitors [see Warnings and Precautions ( 5.6 )] . Active and latent tuberculosis (TB) evaluation: LEQSELVI treatment is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk of TB, start preventive therapy for TB prior to LEQSELVI treatment [ see Warnings and Precautions ( 5.1 ) ]. Viral hepatitis screening in accordance with clinical guidelines: LEQSELVI treatment is not recommended in patients with active hepatitis B or hepatitis C. Hepatitis B infection screening: If hepatitis B infection is discovered, follow hepatitis B clinical guidelines, or refer to a liver specialist.

Increased Risk of LEQSELVI-Associated Serious Adverse Reactions in CYP2C9 Poor Metabolizers or with Concomitant Use of Moderate or Strong CYP2C9 Inhibitors : LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor. ( 5.6 ) Gastrointestinal Perforations: Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms. ( 5.7 ) Lipid Elevations, Anemia, Neutropenia, and Lymphopenia: Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. ( 5.8 ) Immunizations: Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. ( 5.9 ) 5.1 Serious Infections Serious infections have been reported in subjects with alopecia areata receiving LEQSELVI [see Adverse Reactions ( 6.1 )] . Avoid use of LEQSELVI in patients with an active, serious infection including localized infections. Prior to LEQSELVI treatment, consider the risks and benefits in patients: with chronic or recurrent infection who have been exposed to tuberculosis with a history of a serious or opportunistic infection who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection Closely monitor patients for the development of signs and symptoms of infection during and after treatment with LEQSELVI. If the patient develops a serious infection, interrupt treatment with LEQSELVI until the infection resolves or is adequately treated.

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions ( 5.3 )] Thrombosis [see Warnings and Precautions ( 5.5 )] Gastrointestinal perforations [see Warnings and Precautions ( 5.7 )] Lipid Elevations, Anemia, Neutropenia and Lymphopenia [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (≥1%) are: headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of LEQSELVI was evaluated in three randomized, placebo-controlled clinical trials (including a dose-ranging trial), two open-label trials, and two long-term extension trials in adult subjects with severe alopecia areata. These subjects had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than six months.

Lactation: Breastfeeding is not recommended. ( 8.2 ) Severe renal impairment: Not recommended. ( 8.6 ) Severe hepatic impairment: Not recommended. ( 8.7 ) 8.1 Pregnancy Risk Summary Based on the findings from animal reproduction studies, deuruxolitinib may cause fetal harm during pregnancy. Available data from pregnancies reported in clinical trials with LEQSELVI are not sufficient to evaluate for a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of deuruxolitinib to pregnant rats during the period of organogenesis at a dose 4.8 times the maximum recommended human dose (MRHD) resulted in reduced fetal weight and increased skeletal malformation. Oral administration of deuruxolitinib to pregnant rabbits during the period of organogenesis at a dose 0.3 times the MRHD resulted in maternal toxicity, reduced fetal weight, and increased post-implantation loss. Oral administration of deuruxolitinib to pregnant rats during pregnancy and lactation periods at a dose 5 times the MRHD resulted in maternal toxicity, decreased pup survival, and adverse effects on postnatal development (see Data ) . Advise pregnant women of the potential risk to a fetus. The background risks of major birth defects and miscarriage for the indicated population are unknown.

Metabolism

Following oral administration of deuruxolitinib, C max and AUCs increased dose proportionally over a dose range from 8 mg to 48 mg (6 times the approved recommended dosage) in healthy subjects. Steady-state plasma concentrations were achieved within 1 to 2 days, with minimal accumulation, after twice daily administration.

There is no experience regarding human overdose with LEQSELVI. There is no specific antidote for overdose with LEQSELVI. Treatment should be symptomatic and supportive and monitor patients for signs and symptoms of adverse reactions [see Adverse Reactions ( 6.1 )] . In case of overdose, consider contacting the Poison Center at 1-800-222-1222 for latest recommendations.

• Jul 25, 2024NDANDA217900Sun Pharm Inds Inc

1. 1Product Use Issue1222%
2. 2Product Dose Omission Issue1018%
3. 3Drug Ineffective815%
4. 4Therapy Cessation815%
5. 5Acne59.1%
6. 6Headache47.3%
7. 7Condition Aggravated35.5%
8. 8Fatigue35.5%
9. 9Nasopharyngitis35.5%
10. 10Pruritus35.5%
11. 11Abdominal Pain Upper23.6%
12. 12Arthralgia23.6%
13. 13Alopecia11.8%
14. 14Blood Cholesterol Increased11.8%
15. 15Blood Creatine Phosphokinase Increased11.8%

The 4 most recently updated of 4 ClinicalTrials.gov registrations naming Deuruxolitinib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Japanese Adults With Severe Alopecia Areata
  Not yet recruiting · Phase 3 · Interventional · 78 enrolled · Sun Pharma Japan Limited
  NCT07617597updated 2026-06-04
• Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata
  Recruiting · Phase 3 · Interventional · 355 enrolled · Sun Pharmaceutical Industries, Inc.
  NCT07133308updated 2026-01-28
• Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543
  Completed · Phase 1 · Interventional · 16 enrolled · Concert Pharmaceuticals
  NCT05468749updated 2022-11-29
• Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543
  Completed · Phase 1 · Interventional · 21 enrolled · Concert Pharmaceuticals
  NCT05467722updated 2022-11-29

Frequently asked questions

How does Deuruxolitinib work?

Deuruxolitinib is a Janus kinase (JAK) inhibitor. JAKs mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function.

What is Deuruxolitinib used for?

According to FDA labeling, Deuruxolitinib carries indications including: LEQSELVI™ is indicated for the treatment of adult patients with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Deuruxolitinib?

Deuruxolitinib is classified as Janus-associated kinase (JAK) inhibitors, Janus Kinase Inhibitor, Bile Salt Export Pump Inhibitors, Breast Cancer Resistance Protein Inhibitors, Cytochrome P450 2C9 Inhibitors, Janus Kinase Inhibitors, Multidrug and Toxin Extrusion Transporter 2 K Inhibitors, Organic Anion Transporter 3 Inhibitors, Decreased Immunologic Activity.

What are the brand names for Deuruxolitinib?

Deuruxolitinib is marketed under brand names including Leqselvi.

What are the contraindications for Deuruxolitinib?

Deuruxolitinib labeling lists contraindications including: LEQSELVI is contraindicated in patients who: Are CYP2C9 poor metabolizers [see Warnings and Precautions ( 5.6 )] . Are on concomitant moderate or strong CYP2C9 inhibitors [see Warnings and Precautions ( 5.6 )] .. Always consult the full prescribing information and a clinician.