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FDA Approves Deuruxolitinib for Alopecia Areata

Sun Pharma gets fda approval for deuruxolitinib for treating hair loss

The U.S. Food and Drug Administration (FDA) recently approved deuruxolitinib, an oral Janus Kinase (JAK) inhibitor developed by Sun Pharma, for the treatment of severe alopecia areata in adults.

What is Deuruxolitinib?

Marketed under the brand name Leqselvi, deuruxolitinib is an oral JAK inhibitor that selectively targets the JAK1 and JAK2 proteins. These proteins play key roles in immune signaling pathways believed to contribute to hair loss in alopecia areata. JAK inhibitors, including deuruxolitinib, work by disrupting the JAK-STAT signaling pathway. This pathway helps relay signals from cytokines and growth factors to the cell nucleus, where it influences gene expression and immune responses. By inhibiting this pathway, it reduces inflammation and modulates the immune system, helping restore hair growth.

JAK Inhibitors in Alopecia Areata Treatment

Deuruxolitinib is the latest in a growing line of FDA-approved JAK inhibitors for severe alopecia areata. Other approved treatments include:

Ritlecitinib (Litfulo) – Approved in June 2023

Baricitinib (Olumiant) – Approved in June 2022

FDA Approval and Clinical Trials

The FDA’s approval of deuruxolitinib is based on the results of two large phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2. These trials included 1,220 participants with at least 50% scalp hair loss for six months or more. On average, participants began the trials with only 13% scalp hair coverage.

By week 24, approximately one-third of patients treated with deuruxolitinib achieved at least 80% scalp hair coverage, with some experiencing up to 90%. Notably, the studies showed a steady trend of hair regrowth without a plateau in results by the end of the 24-week period, indicating the potential for continued improvement over time.


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