FDA Approves Deuruxolitinib for Severe Alopecia Areata

The US Food and Drug Administration (FDA) has recently approved deuruxolitinib, an oral Janus Kinase (JAK) inhibitor developed by Sun Pharma, for treating severe alopecia areata in adults. 

What is Deuruxolitinib?

Deuruxolitinib, sold under the brand name Leqselvi, is an oral JAK inhibitor that selectively targets JAK1 and JAK2, proteins involved in the immune signaling pathways believed to contribute to hair loss in alopecia areata. JAK inhibitors are a class of medications that target the JAK-STAT signaling pathway, which is critical for transmitting signals from various cytokines and growth factors to the cell nucleus, thereby influencing gene expression and immune response. By inhibiting JAK proteins, these drugs disrupt the JAK-STAT pathway, reducing the transcription of genes involved in inflammatory and immune responses. 

All of the current FDA-approved treatments for severe alopecia areata are JAK inhibitors. Besides deuruxolitinib, there is baricitinib (Olumiant), the first JAK inhibitor approved by the FDA in June 2022, and ritlecitinib (Litfulo), approved in June 2023. 

FDA Approval

The approval of deuruxolitinib follows two large-scale phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2. These trials involved 1,220 participants with alopecia areata who had experienced at least 50% scalp hair loss for six months. The participants began with an average of 13% scalp hair coverage. By week 24, approximately one-third of the patients treated with deuruxolitinib achieved at least 80% scalp hair coverage, with some reaching up to 90%. The studies indicated a consistent trend of hair regrowth among patients, with no plateau in efficacy observed at the 24-week mark. 

Reflections

The approval of deuruxolitinib marks a significant milestone in alopecia areata treatment, offering more choices for people suffering from severe cases. However, Sun Pharma has not yet mentioned when the treatment will be available or how much it will cost. 

Let us know what you think about this treatment in the comments.

10 Comments

  1. James hamilton on July 29, 2024 at 10:28 am

    Does it still work after six months?

  2. YoYo on July 29, 2024 at 1:58 pm

    I guess it’s easier to treat pts with areata, but I hope for the time pts with androgenetic alopecia have some shine in the spotlight lol

  3. Eric on July 31, 2024 at 10:27 am

    I’d like to see the side effects! Can you report any if you find?

    • Avi on August 13, 2024 at 4:32 am

      it suppresses the immune system. so any ailments will last longer and be more severe. it will take longer to get over a cold or a flu.

  4. Andy on July 31, 2024 at 3:44 pm

    https://www.happi.com/breaking-news/grey-hair-treatment-with-pterostilbene-and-nicotinamide/

    Admin, not related but what do you make of this? Or any other news lately regarding gray hair reversal?

    • looking on August 8, 2024 at 11:32 pm

      the patent you mention looks interesting, but it’s a fairly common ingredient combo in longevity supplements. the elysium company sells it as a pill right now. maybe will work a little when applied topically.

    • Paul on September 29, 2024 at 12:56 am

      https://www.sciencedaily.com/releases/2013/05/130503132958.htm

      Grey hair was cured over 10 years ago but still nothing.

  5. Ahmed Bekeer on August 8, 2024 at 2:57 am

    Launching the first cosmetic product to treat gray hair and hair loss in 2026. Potential uses of these pigmentation peptides include: Increased overall skin pigmentation (for example in sunless tans, scars and stretch marks), Increased local skin pigmentation in cases of hypopigmentation (eg vitiligo). Restoring natural hair pigmentation (eg treating gray hair), Reducing skin pigmentation (eg warts and age spots). It is a Swedish biotechnology company with several innovative medicines and dermatological cosmetic products

  6. Sergei on September 2, 2024 at 7:13 pm

    Whats the most exciting things to come out in the next year or so? Fol-005, Hairclone?

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