Sun Pharma Announces LEQSELVI Safety and Efficacy Findings at EADV 2026

New Delhi: Sun Pharmaceutical Industries has announced long-term safety and efficacy findings for LEQSELVI (deuruxolitinib) will be featured in seven presentations at the 2026 European Academy of Dermatology and Venereology (EADV) Congress 2026, including a featured oral presentation reporting long-term safety results from a European open-label extension (OLE) study evaluating up to two years of treatment in adults with severe alopecia areata (AA).

Results from the featured oral presentation found that the safety profile of LEQSELVI remained generally consistent with previous clinical experience through up to two years of open-label treatment in adults with severe AA.

Most treatment-emergent adverse events were mild or moderate in severity, treatment discontinuations due to adverse events were uncommon, and no deaths, thrombosis or major adverse cardiovascular events were reported among patients receiving the FDA-approved dose of 8 mg twice-daily.

Long-term efficacy analyses presented in a poster also showed durable scalp hair regrowth through Week 108 in patients receiving LEQSELVI in the European OLE. Of OLE baseline treatment responders (SALT score ≤20) maintaining response at Week 52 and continuing in the study (nonresponders completed the study at Week 52), 93.9% maintained response at Week 108. Many patients (76.6%) who were baseline nonresponders (SALT score >20) achieved response by Week 52; at Week 52, only responders continued in the study, and of these, 96.8% maintained that response at Week 108. A Severity of Alopecia Tool (SALT) score of 100 represents total scalp hair loss, whereas a score of 0 represents no scalp hair loss.

“Severe alopecia areata is a chronic autoimmune disease, making long-term treatment considerations particularly important for both patients and their clinicians,” said Arash Mostaghimi, MD, MPA, MPH, FAAD, Vice Chair of Clinical Trials and Innovation and Associate Professor of Dermatology at Brigham and Women's Hospital.

“Collectively, these data show durable efficacy and maintenance of response for deuruxolitinib over time and reinforce the growing body of evidence supporting its use as a long-term treatment option for eligible adults.”

Data presented at the EADV Congress 2026 provide additional insights into the long-term treatment experience with LEQSELVI in a chronic autoimmune disease that often requires ongoing management. Additional presentations of pooled post hoc analyses of THRIVE-AA1 and THRIVE-AA2 showed consistent efficacy across clinically relevant patient subgroups, including patients with baseline eyebrow, eyelash or nail involvement, and those with both shorter- and longer-duration disease episodes.

“Our data at EADV 2026 expands our understanding of LEQSELVI beyond initial treatment response and provides important evidence for dermatologists and advance practice providers into long-term tolerability, durability of response, and maintenance of clinical benefit in adults with severe alopecia areata,” said Ahmad Naim, MD, Senior Vice President, North America Chief Medical Officer, Sun Pharma. “We remain committed to advancing research that addresses the significant unmet needs of people living with this autoimmune disease impacting their daily lives.”

LEQSELVI can lower the ability to fight infections. LEQSELVI is not for CYP2C9 poor metabolizers or anyone taking a CYP2C9 inhibitor. Before and during treatment, test for TB and do bloodwork. Serious infections, blood clots, cancers including lymphoma, stomach or intestinal tears have occurred. People 50+ taking a JAK inhibitor with risk for heart disease may have a greater chance of heart attack, stroke, or death. Doctors should be informed about an infection, hepatitis B or C, or when patients are pregnant or planning or have any problems with low blood sugar. Please full Prescribing Information, including Boxed Warning and Medication Guide, and see below for Important Safety Information.

The LEQSELVI data presentation is one of 22 presentations from Sun Pharma across its dermatology and immunology portfolio.

LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 FDA-approved for the treatment of adults with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata.

Sun Pharma Details LEQSELVI’s Indication and Safety Precautions

What is LEQSELVI (deuruxolitinib)?

LEQSELVI is used to treat adults with severe hair loss (alopecia areata). It is not known if LEQSELVI is safe and effective in children.

Who should not take LEQSELVI?

Do not take LEQSELVI if you are a poor metabolizer of CYP2C9 medicines or are taking moderate or strong CYP2C9 inhibitors. Before starting treatment, your healthcare provider should test you for CYP2C9 variants. Tell your healthcare provider if you take moderate or strong CYP2C9 inhibitor medicines. Ask your healthcare provider or pharmacist if you are not sure.

What is the most important safety information I should know about LEQSELVI?

• LEQSELVI is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Some people have had serious infections during treatment with LEQSELVI. Some people may die from these infections. Your healthcare provider should test you for TB before starting treatment with LEQSELVI and should watch you closely for signs and symptoms of TB during treatment. You should not start taking LEQSELVI if you have any kind of infection unless your healthcare provider tells you it is okay.
• There may be an increased risk of major cardiovascular events in people 50 years of age and older who have at least one heart disease risk factor and are taking a medicine in the class of medicines called JAK inhibitors, especially if they are a current or past smoker.
• LEQSELVI may increase your risk of certain cancers by changing the way your immune system works.
• Blood clots in the veins of your legs, lungs or brain (cerebral venous sinus thrombosis, CVT) can happen in some people during treatment with LEQSELVI. These may be lifethreatening.
• Some people taking LEQSELVI can get tears in their stomach or intestines.
• If you have diabetes, your healthcare provider may instruct you to check your blook sugar levels more often during treatment with LEQSELVI. Call your healthcare provider if you have any problems with low blood sugar (hypoglycemia).
• Before you start and taking LEQSELVI and during treatment, your healthcare provider should do blood tests to check for increased fat levels in your blood, Low white and/or red blood cell counts. You should not take LEQSELVI if your white blood cell or red blood cell counts are too low.

What should one tell the healthcare provider before starting LEQSELVI?

Tell healthcare provider if you have an infection; are a current or past smoker; have had a heart attack or other heart problems or stroke; have had blood clots in your legs, lungs or brain; have kidney problems; have liver problems; have any stomach area (abdominal) pain or have been diagnosed with diverticulitis or ulcers in your stomach or intestine; have low red or white blood cell counts; or have recently received or are scheduled to receive a vaccine.

Females who are able to become pregnant should use effective birth control (contraception) during treatment with LEQSELVI. Talk to a healthcare provider if one is planning to become pregnant. One should not breastfeed during treatment with LEQSELVI and for one day after the last dose.

What else should one be aware of when taking LEQSELVI?

Healthcare providers should do blood tests before start taking LEQSELVI and during treatment to check for increased fat (lipid) levels in your blood (triglycerides and cholesterol), low red blood cell counts, or low white blood cells.

How should I take LEQSELVI?

Take LEQSELVI 2 times a day with or without food.

What are the possible side effects of LEQSELVI?

The most common side effects of LEQSELVI include:

• acne

• headache

• pain or swelling of your nose or throat (nasopharyngitis)

• increased blood creatine phosphokinase

• increased blood cholesterol

• tiredness

• weight gain

• increased platelets in your blood (thrombocytosis)

• low red blood cell count (anemia)

• skin and soft tissue infections

• low white blood cell count (neutropenia)

• herpes simplex including cold sores

Further, it is noted that these are not all of the possible side effects of LEQSELVI. "Call your healthcare provider for medical advice about side effects," the release added.