The US Food and Drug Administration has approved baricitinib, sold by Eli Lilly as Olumiant, for people aged 12 and older with severe alopecia areata, an immune condition that makes hair fall out, Lilly announced on September 25, 20261. Until now the once-daily pill was approved for this condition only in adults2. The decision rests on a trial designed specifically for young patients, in which a larger share of teens on the drug regrew most of their scalp hair than teens on a dummy pill1.
What happened
The approval adds teenagers to Olumiant’s existing US label, which already covers adults with severe alopecia areata and adults with moderately to severely active rheumatoid arthritis1. In adults, Olumiant is also approved in the United States for certain COVID-19 patients3.
Alopecia areata is a long-lasting, immune-driven disease that causes unpredictable hair loss3. As many as 2% of people develop it during their lives, and nearly 40% of cases begin before age 20, with earlier onset often linked to more extensive hair loss2. Brittany Craiglow, a dermatologist at Yale School of Medicine, told AJMC that patients describe a “loss of identity,” and that “we see increased rates of anxiety and depression”2.
Baricitinib belongs to a class called JAK inhibitors (short for Janus kinase inhibitors). These pills block inflammatory signals thought to drive the immune attack on hair follicles1.
Europe moved first. The European Medicines Agency’s expert committee recommended the drug for teens in February3, and the European Commission authorized it for ages 12 to under 18 in April 20261.
The evidence behind the decision
The FDA relied on 36-week results from the teen group of a trial called BRAVE-AA-PEDS, described as the first and largest late-stage (Phase 3) trial built specifically for young people with severe alopecia areata1. Phase 3 is the last big round of testing before a drug can be approved.
The trial enrolled teens aged 12 to under 18 who weighed at least 30 kg (about 66 pounds), had lost at least half their scalp hair, and whose current bout of hair loss had lasted between 6 months and 8 years1. Hair loss was scored with the Severity of Alopecia Tool, or SALT, which runs from 0 (no hair loss) to 100 (no scalp hair)1.
In the main group, 257 teens were randomly split into three equal arms: a dummy pill (placebo), a lower dose of 2 mg, or a higher dose of 4 mg, each taken once a day1. The typical teen started with a score of 100, meaning complete scalp hair loss, and had lived with the condition for an average of 6.4 years2.
The main goal was a SALT score of 20 or lower at week 36, which means at least 80% of the scalp covered with hair1. Results at that point:
- 80% or more scalp hair: 42% on the higher dose, 27% on the lower dose, 5% on the dummy pill1.
- 90% or more scalp hair: 37%, 21% and 2%2.
- Eyebrows and eyelashes: teens on the higher dose who started with substantial eyebrow and eyelash loss showed improvement at both sites1.
Longer results were presented at a dermatology meeting in 2025. At 52 weeks, 54.1% of teens on the higher dose reached 80% or more scalp hair and 41.2% reached 90% or more; on the lower dose the figures were 31% and 26.2%2. Among teens on the higher dose who started with severe but not total hair loss, 71% reached that regrowth goal2.
A second group of 166 teens was randomly assigned to one of the two doses, with no placebo arm, to collect more safety data1.
What it does not show yet
The main comparison with a dummy pill lasted 36 weeks1. That shows how much hair grew in that time, not how teens do after years on the drug or after stopping it. Adult data offer a partial guide: in a 3-year analysis of the adult trials, among people who responded and stayed on the same dose, 89.1% on the higher dose and 83.6% on the lower dose still had 80% or more scalp hair at week 1522. Whether teens follow the same pattern has not been reported in these sources.
Most teens did not reach the main goal. Even on the higher dose, more than half had not regrown 80% of their scalp hair by week 361. Outside trials, a real-world study of 48 adults found 58.3% reached that level, while 36.4% were classed as non-responders2.
Safety is the other open question. Lilly described the safety profile in teens as consistent with what was seen in adults1. The label still carries a boxed warning, the FDA’s strongest kind, for serious infections, death, cancer, major heart and blood-vessel events, and blood clots1. In the adult trials, the most common side effects included upper respiratory infections, headache, acne and high cholesterol4. The Clinical Trial Vanguard noted that because the teen label mirrors the adult one, the risk-benefit conversation with families “carries the same complexity”5.
The label sets out when doctors can move patients between the two strengths depending on response, and allows starting on the higher strength for those with near-total or total scalp hair loss1.
Who is behind it
Eli Lilly sponsors the trial6. The drug’s first approval for alopecia areata, in adults in June 2022, was announced jointly by Lilly and Incyte4. Most of the numbers above come from Lilly’s announcement as reported by trade outlets, and the teen results were first presented at the American Academy of Dermatology’s 2025 meeting2.
Lilly’s immunology head, Adrienne Brown, said in a statement:
Today’s approval marks an important milestone for young people living with severe alopecia areata and their families, who have had limited treatment options to date.
Christopher Bunick, a Yale dermatologist and editor in chief of Dermatology Times, called it “an important advance for patients and dermatology providers” in a statement to that publication1.
How it fits the field
When the FDA approved Olumiant for adults in 2022, it was the first pill or injection that works throughout the body (a “systemic” treatment) approved for alopecia areata4. That approval was based on two trials in 1,200 adults, where 32-35% on the higher dose reached 80% or more scalp hair at 36 weeks, versus 3-5% on placebo4. Comparing those numbers with the teen trial is tempting, but results from different trials are not directly comparable5.
According to Bunick, there are now three FDA-approved JAK inhibitors for adults with the condition, but only two for younger patients1. The other is Pfizer’s Litfulo (ritlecitinib), approved for people 12 and older in June 2023, based on a trial of 718 teens and adults2. Olumiant is the second pill approved for this age group2.
Biohack has also covered pills and gels aimed at the more common pattern of hair loss, such as a daily pill for male hair loss. Alopecia areata is a different disease, driven by the immune system.
What to watch next
The trial is not finished. It was designed to enroll teens first and then children aged 6 to under 127. The registry lists it as still recruiting, with about 595 participants planned and main completion expected in March 20286. Results in younger children would decide whether the drug’s use could move below age 12.
The study also includes a long-term extension of about 2 years, with some participants able to stay on treatment for up to 180 weeks6. Those data should show how lasting the regrowth is and whether new safety signals appear in young people.
Access is the practical question. Lilly has insurance-formulary positions with three of the largest pharmacy benefit managers for adults, and whether that coverage extends to teens will shape how many can actually get the drug5.
