Leqselvi (deuruxolitinib) / Sun Pharma - LARVOL DELTA

Evaluating Current and Emergent JAK Inhibitors for Alopecia Areata: A Narrative Review. (PubMed, Dermatol Ther (Heidelb)) - "Recent clinical advances have led to FDA approval of three JAK inhibitors-baricitinib, ritlecitinib, and deuruxolitinib-based on pivotal trials showing significant hair regrowth...Off-label use of JAK inhibitors like tofacitinib and ruxolitinib have also demonstrated efficacy in limited studies. This review aims to consolidate and summarize the latest clinical evidence and trial data on JAK inhibitors for AA, providing an up-to-date resource for clinicians and researchers to guide evidence-based management and optimize therapeutic outcomes."

Journal • Review • Alopecia • Immunology

Safety of oral JAK inhibitors in treating alopecia areata: a systematic review and network meta-analysis. (PubMed, Front Pharmacol) - "Deuruxolitinib was tied to an increased probability of acne occurrence (RR [95% CrI] = 2.74 [1.58, 5.29]) and elevated creatine phosphokinase (CPK) levels (RR [95% CrI] = 1.98 [1.11, 3.93]). Similarly, ritlecitinib was connected to a greater likelihood of elevated CPK levels (RR [95% CrI] = 2.31 [1.01, 6.70])...Oral JAK inhibitors exhibit a favorable safety profile for the treatment of AA. However, baricitinib is more likely to cause acne and infections as opposed to other agents."

Journal • Retrospective data • Review • Acne Vulgaris • Alopecia • Dyslipidemia • Immunology • Infectious Disease • Nephrology

Treatment of alopecia areata with JAK inhibitors: a review of the literature. (PubMed, Acta Dermatovenerol Alp Pannonica Adriat) - "Baricitinib and deuruxolitinib have shown particularly strong results, with significant scalp hair regrowth and acceptable safety profiles. Common adverse effects include acne, elevated lipid levels, and mild laboratory abnormalities, although long-term data remain limited. This review summarizes the mechanisms, efficacy outcomes, and safety data of various JAK inhibitors used in AA and highlights the need for further research to establish optimal dosing, treatment duration, and long-term safety."

Journal • Review • Acne Vulgaris • Alopecia • Immunology

Sun Pharma Announces Launch of LEQSELVI (deuruxolitinib) in the United States for the Treatment of Severe Alopecia Areata (PRNewswire) - "Sun Pharmaceutical Industries Limited...announced LEQSELVI (deuruxolitinib) 8 mg tablets is now available to healthcare providers and people living with severe alopecia areata in the U.S. LEQSELVI is indicated for the treatment of adults with severe alopecia areata....LEQSELVI demonstrated rapid results in clinical trials with one third of patients regaining almost all of their hair by Week 24. Some patients (3%) achieved 80% or more scalp coverage as fast as 8 weeks....THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650) were randomized, double-blind, placebo-controlled clinical trials in 1223 adult patients ages 18-65 with severe alopecia areata at sites in the U.S., Canada and Europe evaluating the regrowth of scalp hair after 24 weeks of dosing using the Severity of Alopecia Tool (SALT) score."

Launch US • Alopecia

Adults with Severe Alopecia Improve Anxiety, Depression with Deuruxolitinib Use (HCPLive) - "The poster was presented during the Dermatology Education Foundation (DERM) 2025 NP/PA CME Conference in Las Vegas, Nevada...These findings on euruxolitinib, which is an oral inhibitor targeting Janus kinase (JAK)1 and JAK2, were previously seen in the phase 3 THRIVE-AA1 (NCT04518995) and THRIVE-AA2 (NCT04797650) clinical analyses...Mostaghimi and coauthors' results suggested that individuals receiving deuruxolitinib 8 mg BID reported having greater average reductions in total HADS, HADS-A, and HADS-D scores as opposed to those in the placebo arm. Notably, the investigative team highlighted that 22.5% of those in the 8 mg BID cohort attained a ≥6-point dip in total HADS score between baseline and the 24-week mark, versus 11.8% in the placebo cohort—a statistically significant difference (P = .0003)."

Retrospective data • Alopecia

Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescents With Severe Alopecia Areata (clinicaltrials.gov) - P3 | N=355 | Recruiting | Sponsor: Sun Pharmaceutical Industries, Inc.

New P3 trial • Alopecia • Dermatology • Immunology

Evaluation of the Efficacy and Treatment-emergent Adverse Events of Deuruxolitinib for Moderate to Severe Alopecia Areata: A Dose-ranging Meta-analysis of 1372 Randomized Patients (Frontiers) - "Three RCTs involving 1372 patients were included. Deuruxolitinib demonstrated a significant improvement in SALT score change from baseline (MD=-47.26, 95% CI= [-53.47, -41.05], P<0.00001, I2=76%), with a significant number of patients achieving 75% (RR=93.66, 95% CI= [23.42, 374.65], P<0.00001, I2=0%) and 90% (RR=65.26, 95% CI= [16.28, 261.58], P<0.00001, I2=0%) improvement from baseline....TEAEs included elevated CPK levels (RR=2.79, 95% CI= [1.5, 4.99], P=0.0006, I2=0%), headaches (RR=1.49, 95% CI= [0.98, 6.54], P=0.06, I2=44%), and acne (significant in the 12mg dose only) (RR=1.80, 95% CI= [0.84, 3.88], P=0.13, I2=64%)."

Adverse events • Retrospective data • Alopecia

Janus kinase inhibitors for alopecia areata: a review of clinical data. (PubMed, Front Immunol) - "Studies have shown that JAK inhibitors exhibited good efficacy and safety in the treatment of AA, with fewer serious side effects. This article reviews the mechanism of action of JAK inhibitors in the treatment of AA and the effects and side effects of representative drugs."

Clinical data • Journal • Review • Alopecia • Immunology • CD8

Impact of switching janus kinase inhibitors in the treatment of severe alopecia areata (SID 2025) - "Patients received their initial JAKi for an average of 24 months (6–65), including baricitinib (n=4), deuruxolitinib (n=1), ruxolitinib (n=1), and tofacitinib (n=2). Limitations include the small sample size, retrospective design, and severity of AA at baseline. A multi-center study is underway to include a larger, more diverse population."

Alopecia • Immunology

JAK Inhibitors and Inflammatory Nail Disorders: A Systematic Review of Clinical Outcomes and Therapeutic Potential. (PubMed, Am J Clin Dermatol) - "This review highlights Janus kinase/Tyrosine kinase 2 inhibitors as a valuable addition to the therapeutic arsenal for inflammatory nail disorders while emphasizing the importance of safety assessments and tailored treatment approaches. The long-term safety of Janus kinase/Tyrosine kinase 2 inhibitors still needs further investigation and the potential for adverse events emphasizes the need for tailored therapeutic strategies, including more studies on topical formulations."

Clinical data • Journal • Review • Infectious Disease • Inflammation • TYK2

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