Baricitinib (Olumiant) Approved by FDA for Alopecia Areata

Around 90-95 percent of people with hair loss suffer from androgenetic alopecia (AGA), also known as male pattern baldness. Just 1-2 percent suffer from alopecia areata (AA), aka patchy hair loss due to an autoimmune problem.

However, in recent years, alopecia areata (and the related alopecia totalis and alopecia universalis) have been in the news almost every week. Most of the coverage tracks miraculous before and after hair growth results via the use of JAK inhibitors. I covered this subject close to ten times a few years ago. More than 300,000 Americans currently live with severe alopecia areata.

FDA Approves Baricitinib for Alopecia Areata

Yesterday, the US FDA approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata. This drug is sold by Eli Lilly and Incyte. This once-a-day pill is the first ever approved in-disease systemic treatment for adults with severe alopecia areata (AA). Monthly cost without insurance will be $2,500.

Olumiant is a Janus kinase (JAK) inhibitor that blocks the activity of a family of enzymes. This in turn interferes with the pathway that leads to inflammation in alopecia areata. Note that Olumiant is already approved for treating moderate and severe rheumatoid arthritis. It is available in 4 mg, 2 mg and 1 mg tablets (with the recommended dose for AA being 2 mg per day).

The approval for alopecia areata was based on Lilly’s BRAVE-AA1 and BRAVE-AA2 trials. These were the largest Phase 3 clinical trials ever completed in humans suffering from AA. Both trials were led by Yale University’s Dr. Brett King.

Patients in the Lilly study experienced relatively mild side effects, including slightly increased risk of acne, urinary tract infections and other infections. Those side effects were easily treatable or improved without treatment. Around one-half of patients regrew their hair after one year of treatment.

Baricitinib Hair Growth
Baricitinib Hair Growth in Alopecia Areata Patients. Before and After. Source: Dr. Brett King et al in the New England Journal of Medicine.

Note that it was Aclaris Therapeutics which originally got the patent rights for the use of baricitinib in treating hair loss in 2017. Earlier this year, I also discussed some phenomenal baricitinib hair growth results. The before and after photos (seen above) are courtesy of Dr. Brett King and his work.

JAK Inhibitors

A number of other JAK inhibitors have shown impressive results in treating alopecia totalis and universalis. Among the more famous of these include ruxolitinib, tofacitinib and decernotinib. See all my past posts covering JAK inhibitors for more details.

Pfizer (Ritlecitinib) and Concert Pharmaceuticals (CTP-543) are also planning to release JAK inhibitors to treat alopecia areata in the near future.

23 thoughts on “Baricitinib (Olumiant) Approved by FDA for Alopecia Areata”

  1. Hey folks, does anyone now if it’s possible to stop hair shedding? I’ve been having Androgenetic alopecia for sometime now and I need something to stop the shedding. Growing more hair is not a priority. Saving all the hair I’ve got left is what important. :/

    Are there any shampoos, vitamins etc. that would help me or is taking drugs like Minoxidil/finasteride is the only solution? Ideally I’d like to avoid any drugs, because of the possible side effects.

    1. I heard one guy on the forums claiming that topical melatonin stopped his shedding. Personally, Vitamin D has helped me reduce shedding. Please note that shedding may not necessarily mean hair loss.

      1. Thanks, Kianu. I’ll check it out.

        What else can shedding mean if not hair loss? Just curious. I shed a lot lol

        1. Shedding can happen for many reasons. Could be your response to medications, stress or a seasonal shed. The hairs usually comes back when they fall but for us balding people they come back thinner and thinner until it is no longer visible. If you are taking finasteride and minoxidil you are taking the right step to stopping this. Do expect a shed for a few months while on those medications but that’s a good sign that the medication is working. I hate taking these drugs too but this is the only choice we have if we want to preserve our hair.

    2. 1-Vitamin D 50,000 IU per day (check your levels)
      2-Vitamin B complex 1 gram per day
      3-Microneedling 1.5 once a week
      4-Wooden brush massages daily 10 minutes
      5-Head massager during showering with Nizoral 2%
      6-Oral castor oil 5 ml per day
      7- onion garlic apple cider vinegar mask weekly
      8- nettle root tea daily

      Worked great for me

          1. That 2015-2019 period was the golden era of hairlosshope for me. I checked this website every. single. day.

            1. True dat Toccata…Histogen, Replicel, JAK, Bimatoprost, it was a wild time! Meanwhile, I sit here scratching my head (literally), haven’t come up with a cure (or better treatments) for seborrheic dermatitis let alone hair loss. While it can be a tall order we can do is keep hope alive. Nasa RS and his unbridled optimism would approve.

  2. I think I would pass out if you actually make a similar post for Androgenic Alopecia some time in the meaningful rest of my life!!!!!

      1. Good for these folks (no sarcasm). It’s a small percentage compared to us, but their suffering is real and if this helps them, awesome.

    1. Oh Gawd we need a post for a cure on androgenetic alopecia that won’t cause devastating side effects.

  3. While I am amusing myself with thoughts of a game changing treatment, is this securities fraud: “Follica completed an optimization trial, and a Phase 3 registration study in androgenetic alopecia is expected to begin in 2022.”

  4. “The list price of Olumiant is $2,497.20 for a 30-day supply of 2 mg tablets.” This drug may be partially covered by insurance whereas an Androgenetic pill probably wouldn’t be—so we’d have to hope a cure for us would be significantly less expensive, otherwise we’d blow through hair transplant money in a year.

    1. I understand that these companies must have a profit, but charging such a high amount is an ignoble thing to do, very sad, I don’t even want to imagine how much a treatment will cost for us …

  5. The FDA approved the medication with a black box warning. It states:

    “Serious Infections: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death.”

    WTF … if something like this is written on an eventual cure for AGA, there is no way I’ll use it.

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