What is deuruxolitinib?

Deuruxolitinib is a JAK inhibitor medicine for the treatment of severe alopecia areata (AA) in adults. Severe AA means that someone has more than 50% scalp hair loss because of this autoimmune condition.

Its commercial brand name is Leqselvi™, and it is produced by Sun Pharma. The recommended dose is 8 milligrams (mg) to be taken twice per day, in tablet form, by mouth. 

Clinical trial results

Two large clinical trials were done from 2021 to 2022, in which a total of 1223 people affected by severe AA took part. Clinical trials are research studies to test how well the medicine works and how safe it is (more information about clinical trials). These trials were called THRIVE-AA1 and THRIVE-AA2 and were set up in the same way. 

The amount of hair loss that people had at the start of the trials varied from person to person, but on average they had 85% scalp hair loss. The duration of their ‘current episode’ of hair loss was on average 3.5-4 years, although in some it had started only 6 months before starting the trial, and in some others, it started as much as 10 years before. People with a ‘current episode’ longer than 10 years were not included in the trials.

Participants then received the study medicine for 24 weeks. They were randomly assigned into one of three groups: deuruxolitinib 12 mg, deuruxolitinib 8 mg, or placebo. At the end of the 24 weeks, the results across both trials combined were as follows:

• On deuruxolitinib 8 mg, 30-33% of people reached a point where more than 80% of their scalp had hair growth.
• On deuruxolitinib 12 mg, 38-42% of people reached a point where more than 80% of their scalp had hair growth.

What were the side effects?

During clinical trials, all negative health effects that happen are recorded. These are called ‘adverse events’. These are different from side effects, because it can not always be determined if they happen because of the medicine, or would have happened anyway. For example, people may have been infected by the flu or COVID, or experienced headaches, and it is not clear if this was because of the medicine.

• 54-74% of people experienced “mild” adverse events on deuruxolitinib 12 mg or 8 mg, compared to 48-70% on placebo. “Moderate” adverse events were seen in 25-32% on deuruxolitinib, compared to 16-26% on placebo. And 2-6% experienced “severe” adverse events on deuruxolitinib, compared to 1-3% on placebo.
• The most common adverse events seen were viral infections (such as COVID or flu), headaches (10-12%), acne (9-12%), and increased blood creatine kinase levels (4-11%).
• Serious adverse events happened 1.1-1.2% on deuruxolitinb 8 mg, 0.5-1.6% on deuruxolitinib 12 mg, compared to 0-2.9% of people on placebo.
• 2-3% of people on either deuruxolitinib dose had to stop treatment due to an adverse event, compared to 1% on placebo.
• Around 30% of adverse events were “possibly” related to the study medicine, around 12% were “probably” related, and around 3% were “definitely” related.
• No myocardial infarctions, strokes, malignancies, or thromboembolic events were reported in patients receiving deuruxolitinib during the trials.

Were there any differences in how quickly people responded?

They compared people who had ‘partial’ scalp hair loss (ranging from 50-94%) before starting, to people with ‘complete or near-complete’ scalp hair loss (95-100%). After 24 weeks, people with ‘partial’ scalp hair loss at the start were more likely to have meaningful hair regrowth (reaching 80% or more scalp hair growth).

However, a limitation of these trials was that they only tested the medicine for 24 weeks. An ‘open-label extension’, in which people were allowed to continue treatment beyond 24 weeks, suggests that the number of people achieving meaningful hair regrowth continued to improve. In addition, of people that continued to 68 weeks on the 8 mg dose, 99.6% stayed under 50% scalp hair loss, showing the response to treatment is maintained well.

The full results of the two phase 3 clinical trials were published in the Journal of the American Academy of Dermatology:

Results from THRIVE-AA1 

Results from THRIVE-AA2

You may also wish to read this announcement about long-term extension data.