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Home > Articles > FDA Allows Hair Loss Drug Study to Move Forward

FDA Allows Hair Loss Drug Study to Move Forward

by Jane Meggitt

The FDA is allowing Concert Pharmaceuticals to resume clinical trials of its hair loss drug, CTP-543, or deuterated ruxolitinib. The medication is designed to prevent hair loss in patients diagnosed with moderate to severe alopecia areata. This autoimmune disease causes hair loss on the scalp, resulting large patches of hair falling out. The condition results from the immune system attacking hair follicles. There are several types of alopecia, some of which cause total baldness. That is not the case with alopecia areata. Roughly 4.6 million Americans have some form of the disease.

Trial, Interrupted

In May, the FDA stopped the clinical trial because it wanted additional data. Safety concerns were not among the reasons cited for the stoppage. Concert Pharmaceuticals, founded in 2006 and based in Lexington, Massachusetts, reported it would modify the design study for the drug. The trial will now go ahead with 90 patients, half of whom will receive the drug and the other half a placebo twice daily. The study’s completion is expected by the end of next year, with the primary results expected after 24 weeks of patient dosing.


Ruxolitinib is used to treat certain blood disorders, and is marketed under the name Jakafi in the U.S. Academic studies have already shown the drug as effective in treating hair loss. Concert Pharmaceuticals’ applied its deuterium chemistry technology to ruxolitinib, which modifies the drug.

Alopecia Areata Treatment

There is no cure for alopecia areata. Currently, alopecia areata treatment consists of regular corticosteroid injections into the scalp, which may promote hair growth in some people. If the injections work, some hair regrowth is generally evident within a month of starting treatment, according to the National Alopecia Areata Foundation. However, these injections are usually successful only in patients with milder cases of the disorder. The addition of topical minoxidil to the corticosteroid injection regimen improves the odds of hair regrowth.

Anthralin ointment, a tar-like substance used for treating psoriasis, may aid alopecia areata sufferers. The patient must apply the ointment to the hairless patches once daily, leave it on for up to one hour, and then wash it off. If hair regrowth takes places, it typically does so within two to three months. Topical corticosteroids are used to ease scalp inflammation arising from alopecia areata.

None of the current treatments are overwhelmingly effective and some are not that easy or pleasant to use. Alopecia areata patients eagerly await the results of the CTP-543 trial.

If you or someone you know would like to learn more about hair loss and how to treat it, please feel free to schedule a consultation or contact one of our representatives today!

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