Leqselvi (deuruxolitinib) / Sun Pharma - LARVOL DELTA

Properties of FDA-approved small molecule protein kinase inhibitors: a 2025 update. (PubMed, Pharmacol Res) - "Seven drugs (abrocitinib, baricitinib, deucravacitinib, deuruxolitinib, ritlecitinib, tofacitinib, upadacitinib) are prescribed for the management of inflammatory diseases (atopic dermatitis, rheumatoid arthritis, psoriasis, alopecia areata, and ulcerative colitis)...The following four drugs received FDA approval in 2024 - deuruxolitinib (alopecia areata), ensartinib and lazertinib (non-small cell lung cancer), and tovorafenib (pediatric glioma) while mirdametinib was approved in 2025 for the treatment of type I neurofibromatosis (von Recklinghausen disease). Apart from netarsudil, temsirolimus, and trilaciclib, the approved protein kinase blockers are orally bioavailable. This article summarizes the physicochemical properties of all 85 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, ligand efficiency, lipophilic efficiency, polar surface area, and solubility. A total of 39 of the 85..."

FDA event • Journal • Review • Alopecia • Atopic Dermatitis • Brain Cancer • Chronic Myeloid Leukemia • CNS Tumor • Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Glioma • Hematological Malignancies • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Leukemia • Lung Cancer • Neurofibromatosis • Non Small Cell Lung Cancer • Oncology • Pediatrics • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Solid Tumor • Ulcerative Colitis • MAP2K1

The Relative Efficacy and Safety of Monotherapies for Alopecia Areata: A Network Meta-Analysis Study. (PubMed, J Cosmet Dermatol) - "We produced high-quality evidence on the comparative effectiveness of monotherapies for AA with various regimens of 8 JAKIs, including the FDA-approved ones. Our findings can improve clinicians' decision-making and update guidelines for medical practice."

Clinical • Journal • Retrospective data • Review • Alopecia • Immunology

Sun Pharma snags appeals win over Incyte, clearing way for US launch of alopecia med Leqselvi (Fierce Pharma) - "After a legal decision delayed its entry last fall, Sun Pharma has received the all-clear to tap into the U.S. alopecia market with its JAK inhibitor Leqselvi, teeing up a potential showdown with rival autoimmune meds from Eli Lilly, Incyte and Pfizer. After Sun appealed an injunction handed down in New Jersey federal court in November that blocked Leqselvi’s U.S. launch, the U.S. Court of Appeals for the Federal Circuit on Wednesday ruled in favor of the Indian drugmaker. Sun is no longer under any court order delaying or restricting Leqselvi’s market debut, the company said in an April 10 filing (PDF) on the Bombay Stock Exchange....Sun will proceed with Leqselvi’s rollout stateside and says it plans to discuss launch plans 'in due course of time'."

Corporate lawsuit • Alopecia

Network meta-analysis (NMA) of FDA-approved JAK inhibitors for alopecia areata (AA) with at least 50% hair loss per SALT score. (AAD 2025) - "Background: For adult patients with severe AA, 3 Janus kinase (JAK) inhibitors are currently approved in the United States: baricitinib (2 mg and 4 mg regimens), ritlecitinib (50 mg regimen), and deuruxolitinib (8 mg regimen). Deuruxolitinib was associated with numerically or statistically greater efficacy when compared to other approved systemic JAK inhibitors for severe AA."

Retrospective data • Alopecia • Immunology

Switching between Janus kinase inhibitors for treatment of alopecia areata (AAD 2025) - "Partial responses were observed in patients switched from deuruxolitinib to baricitinib and then ritlecitinib (n=1), and from ruxolitinib to tofacitinib and then baricitinib (n=1). Switching JAKis may benefit patients with severe alopecia areata who fail initial treatment. Whether this is due to dose effect or JAK specificity requires further study."

Alopecia • Immunology

Patient Preferences for the Treatment of Alopecia Areata (AAD 2025) - "This study found that, with regard to JAK-inhibitor treatment options in AA, given similar safety profiles, patients prefer higher efficacy and shorter time to initial hair regrowth, regardless of daily or twice daily dosing."

Clinical • Alopecia • Immunology

Medicaid Insurance Coverage for Treatment of Alopecia Areata with Janus Kinase Inhibitors (AAD 2025) - "Alopecia areata (AA) is an autoimmune disorder causing patchy hair loss, with recently FDA-approved Janus kinase (JAK) inhibitors (baricitinib, ritlecitinib, and deuruxolitinib) enabling effective treatment of moderate-to-severe AA. Dermatologists should also champion policy updates to bridge the large coverage gap for baricitinib between AA and RA treatment. Advocacy efforts are needed to improve Medicaid coverage and ensure equitable access to JAK inhibitors for treating AA."

Medicaid • Reimbursement • US reimbursement • Alopecia • Dermatology • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Discrete Choice Experiment to Assess Clinician Preferences for the Treatment of Alopecia Areata (AAD 2025) - "Blinded profiles approximating baricitinib 4mg, ritlecitinib, and deuruxolitinib 8mg were ranked as most and least preferred. Our study demonstrated that, regarding JAK-inhibitor treatment of AA, clinicians preferred options with higher efficacy and shorter time to onset, regardless of daily or twice daily dosing."

Clinical • Alopecia • Dermatology • Immunology

Optimization of deuruxolitinib dosing in adult patients with alopecia areata: Results from a randomized, parallel-group, multicenter, Phase 2 trial (AAD 2025) - P2 | "Hair regrowth was greater with deuruxolitinib 8 mg BID; BID dosing was carried into Phase 3 trials."

Clinical • P2 data • Alopecia • Immunology • JAK1

Improvement in anxiety and depression in adult patients with severe alopecia areata treated with deuruxolitinib: Pooled data from the THRIVE-AA1 and THRIVE-AA2 Phase 3 trials (AAD 2025) - P3 | "Deuruxolitinib 8 mg BID was associated with clinically meaningful improvement in the overall HADS, HADS-A, and HADS-D scores from baseline to Week 24 in patients with severe AA."

Clinical • P3 data • Alopecia • CNS Disorders • Depression • Immunology • Mood Disorders • Psychiatry • JAK1

Change in patient-reported hair satisfaction during deuruxolitinib treatment of severe alopecia areata: Pooled data from the Phase 3 THRIVE-AA1 and THRIVE-AA2 trials (AAD 2025) - P3 | "More than 95% of patients who achieved clinically meaningful hair regrowth with deuruxolitinib 8 mg BID changed their scalp hair self-assessment from baseline dissatisfaction to satisfaction at W24."

Clinical • P3 data • Alopecia • Immunology • JAK1

Most men choose eyebrows versus scalp hair: a response to "Evaluation of Eyebrow and Eyelash Regrowth and Patient Satisfaction in the Phase 3 THRIVE-AA2 Trial of Deuruxolitinib in Adult Patients with Alopecia Areata". (PubMed, J Am Acad Dermatol) - No abstract available

Journal • P3 data • Alopecia • Immunology

Incyte blocks US launch of Sun Pharma's alopecia drug (pharmaphorum) - "A US district court has granted an injunction sought by Incyte on the launch of Sun Pharma's recently approved Leqselvi for alopecia areata. In a brief filing with the National Stock Exchange (NSE) of India, the company confirmed that on 1st November the New Jersey court decided to grant a preliminary injunction that will delay the launch of Leqselvi (deuruxolitinib), which was approved by the FDA in July....Incyte filed a lawsuit to try to block the launch of Leqselvi, claiming that the drug infringed a US patent (No. 9,662,335) it holds on the use of ruxolitinib, a JAK inhibitor it sells as Jakafi to treat various haematological cancers and in a topical form as Opzelura for atopic dermatitis and vitiligo."

Corporate lawsuit • Alopecia • Dermatology • Immunology

Sun Pharma Announces Multiple Data Presentations Highlighting its Dermatology Portfolio to be Featured at the 2024 Fall Clinical Dermatology Conference (PRNewswire) - "Sun Pharmaceutical Industries Limited...today announced it will present more than a dozen posters at the 44th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024, in Las Vegas, Nevada. The presentations will include data from across the Sun Pharma dermatology portfolio, including study results for LEQSELVI (deuruxolitinib)...ILUMYA (tildrakizumab-asmn)....Six abstracts, accepted for poster presentations, will highlight clinical efficacy and safety data of LEQSELVI (deuruxolitinib)..."

Clinical data • Alopecia • Immunology • Psoriasis

Sun Pharma Presents LEQSELVI (deuruxolitinib) Data Highlighting Clinical Efficacy & Durability for Treatment of Alopecia Areata at the 2024 Fall Clinical Dermatology Conference (PRNewswire) - "Sun Pharmaceutical Industries Limited...today presented new data highlighting the clinical efficacy and safety of LEQSELVI (deuruxolitinib) 8 mg tablets at the 44th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024, in Las Vegas, Nevada....LEQSELVI data presented at Fall Clinical includes pooled long-term results from open-label extension (OLE) studies showing ongoing and clinically meaningful improvements in scalp hair regrowth in adults with AA...At the end of the qualifying trial period at Week 24, 32.6% of patients receiving LEQSELVI 8 mg BID (twice daily) achieved a SALT ≤20 score; the percentage of SALT 20 responders increased to 48.8% (LOCF analysis) and 76.6% (AO analysis) at Week 68 of the OLE studies. Additionally, 99.6% (282 patients) maintained their response to LEQSELVI 8 mg BID..."

Clinical data • Retrospective data • Alopecia • Dermatology

Sun Pharma Presents New Clinical Efficacy and Safety Data in Severe Dermatological Conditions at the 2024 European Academy of Dermatology and Venereology (EADV) Congress (PRNewswire) - "Sun Pharmaceutical Industries Limited...today announced that it will present abstracts across its dermatology portfolio at the 33rd European Academy of Dermatology and Venereology (EADV) Congress being held in Amsterdam, Netherlands from September 25-28, 2024."

Clinical data • Alopecia • Dermatology • Immunology • Psoriasis

Optimization of deuruxolitinib dosing in adult patients with alopecia areata: Results from a randomized, parallel-group, multicenter, Phase 2 trial (EADV 2024) - P2 | "Deuruxolitinib 8 mg BID resulted in greater improvement relative to deuruxolitinib 16 mg QD, and BID dosing was carried into the Phase 3 trial program."

Clinical • P2 data • Alopecia • Immunology • JAK2

Improvement in anxiety and depression in adult patients with severe alopecia areata treated with deuruxolitinib: Pooled data from the THRIVE-AA1 and THRIVE-AA2 Phase 3 trials (EADV 2024) - P3 | "A significantly greater proportion of patients treated with deuruxolitinib 8 mg BID vs placebo reported clinically meaningful improvement in overall HADS score, as well as the HADS-A and HADS-D subscales, from baseline to Week 24."

Clinical • P3 data • Alopecia • CNS Disorders • Depression • Immunology • Mood Disorders • Psychiatry

Change in patient-reported hair satisfaction during deuruxolitinib treatment of severe alopecia areata: Pooled data from the Phase 3 THRIVE-AA1 and THRIVE-AA2 trials (EADV 2024) - "More than 95% of patients who achieved clinically meaningful hair regrowth (SALT score ≤ 20) during 24 weeks of deuruxolitinib 8 mg BID treatment changed their assessment of their scalp hair from dissatisfaction at baseline to satisfaction at Week 24."

Clinical • P3 data • Alopecia • Immunology

European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata (clinicaltrials.gov) - P3 | N=407 | Completed | Sponsor: Concert Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Alopecia • Dermatology • Immunology

Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata (clinicaltrials.gov) - P2/3 | N=1000 | Active, not recruiting | Sponsor: Concert Pharmaceuticals | Trial primary completion date: Jan 2025 ➔ May 2025

Trial primary completion date • Alopecia • Dermatology • Immunology

Efficacy and safety of deuruxolitinib, an oral selective Janus kinase inhibitor, in adults with alopecia areata: Results from the Phase 3 randomized, controlled trial (THRIVE-AA1). (PubMed, J Am Acad Dermatol) - P3 | "Both doses of deuruxolitinib were effective for hair regrowth. Patient satisfaction aligned with hair growth."

Clinical • Journal • P3 data • Alopecia • Immunology

U.S. FDA Approves LEQSELVI (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata (PRNewswire) - "Sun Pharmaceutical Industries Limited...announced that the U.S. Food and Drug Administration (FDA) approved LEQSELVI (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata....The approval is based on data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials THRIVE-AA1 and THRIVE-AA2, which enrolled a total of 1,220 patients with alopecia areata who had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than six months."

FDA approval • Alopecia

Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata (clinicaltrials.gov) - P2/3 | N=1000 | Active, not recruiting | Sponsor: Concert Pharmaceuticals | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Alopecia • Dermatology • Immunology

Anti-JAK: between safety and quality of life (EADV-Sp 2024) - "The JAK inhibitors used by the patients were Baricitinib in 55.2%, Tofacitinib in 31%, and Deuruxolitinib in 13.8%. Our study has demonstrated a spectacular improvement in the quality of life of patients with alopecia areata after treatment with JAK inhibitors. Further studies are needed to evaluate their long-term safety"

Clinical • HEOR • Acne Vulgaris • Alopecia • CNS Disorders • Dermatology • Dyslipidemia • Hematological Malignancies • Immunology • Lung Cancer • Lymphoma • Metabolic Disorders • Mood Disorders • Oncology • Psychiatry