Two Phase 3 trials involving 1,399 adults and adolescents found substantial scalp, eyebrow, and eyelash regrowth with upadacitinib after 24 weeks. The results are promising, but long-term safety, durability, and FDA approval for alopecia areata remain unresolved.
Two randomized Phase 3 trials found that upadacitinib produced substantial scalp-hair regrowth in many adults and adolescents with severe alopecia areata after 24 weeks.
The two prespecified replicate trials produced closely consistent results. About 45% of participants receiving 15 mg once daily and 54% to 55% receiving 30 mg reached at least 80% scalp-hair coverage, compared with 1.5% to 3.4% receiving placebo (Mostaghimi et al., 2026).
The findings do not show that upadacitinib cures alopecia areata or that regrowth persists after treatment stops. The published placebo-controlled comparison lasted 24 weeks; approximately half of treated participants did not reach the primary endpoint, and upadacitinib carries an FDA boxed warning addressing serious risks associated with systemic JAK inhibition (U.S. Food and Drug Administration [FDA], 2026).
Key Takeaways
- Two randomized Phase 3 trials included 1,399 adults and adolescents with severe alopecia areata (Mostaghimi et al., 2026).
- At week 24, 44.6% to 45.2% receiving 15 mg and 54.3% to 55.0% receiving 30 mg reached at least 80% scalp-hair coverage, versus 1.5% to 3.4% receiving placebo.
- The 30 mg dose generally produced greater scalp, eyebrow, and eyelash improvement, but overall adverse events were also more frequent.
- Only 118 participants were adolescents, limiting the precision of adolescent-specific estimates and the ability to detect uncommon risks.
- The trials did not compare upadacitinib with another alopecia treatment.
- The 24-week findings cannot establish long-term safety, durability of regrowth, or what happens after upadacitinib is stopped.
- As of August 2026, alopecia areata is not listed as an FDA-approved indication for upadacitinib (FDA, 2026).
What the UP-AA Trials Found
UP-AA1 and UP-AA2 were multinational, randomized, double-blind, placebo-controlled Phase 3 trials. UP-AA1 randomized 676 participants and UP-AA2 randomized 723, for 1,399 participants overall. The population included 1,281 adults and 118 adolescents (Mostaghimi et al., 2026).
Participants had severe alopecia areata, defined for enrollment as at least 50% scalp-hair loss. Their mean baseline Severity of Alopecia Tool, or SALT, score was 83.9, corresponding to approximately 84% scalp-hair loss.
Participants received upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily.
The primary endpoint was a SALT score of 20 or lower at week 24, meaning 20% or less scalp-hair loss.
| Trial | Placebo | Upadacitinib 15 mg | Upadacitinib 30 mg |
|---|---|---|---|
| UP-AA1 | 1.5% | 45.2% | 55.0% |
| UP-AA2 | 3.4% | 44.6% | 54.3% |
Both doses were statistically superior to placebo. The closely consistent results across the two prespecified replicate trials strengthen confidence in the short-term treatment effect, although both trials were conducted within the same sponsor-supported development program (Mostaghimi et al., 2026).
Phase 3 UP-AA trials found substantial scalp, eyebrow, and eyelash hair regrowth with upadacitinib after 24 weeks, although long-term safety and durability remain unclear.
Substantial Regrowth Did Not Mean Complete Regrowth
A SALT score of 20 still permits up to 20% scalp-hair loss.
At the stricter threshold of SALT 10 or lower, response rates were 35.2% and 36.0% with 15 mg and 45.8% and 47.1% with 30 mg. Placebo response rates were 0.7% and 1.4% (Mostaghimi et al., 2026).
Complete scalp regrowth occurred in a smaller proportion of participants.
The results can also be viewed from the opposite direction. At week 24, approximately 55% of participants receiving 15 mg and 45% receiving 30 mg had not reached the SALT ≤20 primary endpoint.
Upadacitinib therefore produced substantial regrowth in many participants, but response was not universal.
Eyebrow and Eyelash Hair Also Improved
Among participants with significant eyebrow loss at baseline, approximately 41% to 42% receiving 15 mg and 59% to 62% receiving 30 mg achieved the prespecified eyebrow improvement endpoint. Placebo responses ranged from approximately 1% to 3% (Mostaghimi et al., 2026).
For eyelash loss, approximately 43% to 44% responded to 15 mg and 59% to 61% responded to 30 mg, compared with approximately 4% to 6% receiving placebo.
Several patient-reported outcomes also improved. Effects on anxiety and depression measures, however, were inconsistent across trials and doses. The results should therefore not be interpreted as evidence that upadacitinib treats anxiety or depression.
What the Adolescent Results Mean
The trials included 118 adolescents aged 12 to 17 years. Their efficacy results supported the overall findings, and investigators reported a short-term safety profile similar to that observed in adults (Mostaghimi et al., 2026).
However, 118 adolescents divided across treatment groups and two trials provide a limited pediatric evidence base. The subgroup cannot precisely characterize uncommon adverse events or establish long-term safety.
The trials also do not establish efficacy or safety in children younger than 12.
How Upadacitinib Works
Upadacitinib is an oral Janus kinase inhibitor with greater inhibitory activity against JAK1 than several other JAK-family enzymes.
JAK signaling helps transmit immune signals inside cells. In alopecia areata, immune activity disrupts normal hair-follicle function. Inhibiting JAK-dependent signaling can reduce inflammatory activity and allow existing follicles to resume hair production.
The trials provide Phase 3 evidence that a JAK1-preferential inhibitor can produce clinically meaningful hair regrowth in severe alopecia areata. They do not establish that preferential JAK1 inhibition alone explains the treatment effect (Mostaghimi et al., 2026).
What Adverse Events Occurred?
In the pooled safety population, treatment-emergent adverse events occurred in 57.1% of placebo recipients, 62.7% receiving 15 mg, and 67.1% receiving 30 mg. Serious adverse events occurred in 0.4%, 1.6%, and 2.3%, respectively (Mostaghimi et al., 2026).
Common events included upper respiratory tract infection, acne, elevated blood creatine phosphokinase, and nasopharyngitis.
Acne occurred in 3.6% with placebo, 11.7% with 15 mg, and 16.3% with 30 mg. Neutropenia occurred in 0.4%, 2.2%, and 3.9%, while elevated creatine phosphokinase occurred in 3.9%, 5.2%, and 6.6%, respectively.
Herpes zoster occurred in 0.4%, 0.7%, and 1.1%.
No deaths or adjudicated major adverse cardiovascular events occurred during the reported 24-week period. One adjudicated venous thromboembolic event occurred in the 15 mg group in a participant with several preexisting risk factors. One malignancy was reported in the 15 mg group in a participant with breast nodules identified before enrollment (Mostaghimi et al., 2026).
The small number of serious events and limited duration mean these trials cannot determine the frequency of uncommon long-term harms.
Why the FDA Boxed Warning Still Matters
The current FDA prescribing information for Rinvoq carries a boxed warning addressing serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis (FDA, 2026).
The UP-AA population had a mean age of about 36 years, and the placebo-controlled findings cover only 24 weeks. The trials therefore cannot reliably estimate rare cancers, cardiovascular events, thrombosis, or other uncommon harms that may emerge during prolonged treatment.
The 30 mg dose produced greater hair regrowth but also higher overall and serious adverse-event rates, with numerical increases in acne, elevated creatine phosphokinase, and neutropenia (Mostaghimi et al., 2026).
If upadacitinib is approved for alopecia areata, clinical use would require an individualized benefit-risk assessment and the screening, monitoring, and precautions specified in the applicable prescribing information.
How Does Upadacitinib Compare With Other Alopecia Treatments?
The UP-AA trials used placebo, not an active treatment. They therefore cannot establish that upadacitinib is safer, more effective, faster, or more durable than another JAK inhibitor.
The FDA has approved baricitinib for adults with severe alopecia areata, ritlecitinib for adults and adolescents aged 12 years and older, and deuruxolitinib for adults with severe alopecia areata (FDA, 2022, 2023, 2024).
Response percentages from separate drug-development programs should not be treated as head-to-head comparisons. Differences in study populations, endpoint timing, treatment duration, statistical methods, and other design features can affect apparent response rates.
Direct comparative trials would be needed to establish whether one treatment provides a clinically meaningful advantage over another.
Is Upadacitinib FDA Approved for Alopecia Areata?
Not currently.
Upadacitinib is marketed as Rinvoq for several inflammatory conditions, but the FDA prescribing information current in August 2026 does not list alopecia areata among its approved indications (FDA, 2026).
The UP-AA clinical program includes evaluation beyond the published 24-week placebo-controlled findings (ClinicalTrials.gov, 2026).
Because regulatory status can change, the current FDA label should be checked again when this article is updated.
How Long Does Hair Regrowth Last?
The published UP-AA findings do not establish how long regrowth persists with prolonged treatment or what happens after upadacitinib is discontinued.
A separate randomized withdrawal study involving baricitinib illustrates why drug-specific durability data matter. By week 152, 80% of responders who had been switched from baricitinib to placebo had lost treatment benefit, compared with 7% who continued baricitinib (King et al., 2024).
Those findings concern baricitinib, not upadacitinib. They cannot establish what will happen after upadacitinib withdrawal.
Upadacitinib-specific maintenance and withdrawal data are therefore needed.
Important Study Limitations
Several limitations define what can and cannot be concluded from the trials:
- The published placebo-controlled comparison lasted 24 weeks. It cannot establish long-term durability or uncommon cumulative risks.
- There was no active comparator. The trials cannot establish superiority over another approved alopecia treatment.
- Approximately half of treated participants did not reach the primary endpoint. Response was substantial but not universal.
- The primary endpoint did not require complete regrowth. SALT ≤20 still permits up to 20% scalp-hair loss.
- Only 118 adolescents participated. Adolescent-specific estimates are less precise, particularly for uncommon harms.
- Older adults were not adequately represented. This limits conclusions for a population that may have different baseline risks.
- The trials were industry funded. AbbVie funded the studies and manufactures upadacitinib.
According to the publication, AbbVie participated in study design and research, data collection, analysis and interpretation, and manuscript preparation and review. Several authors were AbbVie employees or reported financial relationships with the company (Mostaghimi et al., 2026).
Industry sponsorship does not invalidate randomized findings, but independent evaluation, longer follow-up, regulatory review, and postmarketing surveillance remain important.
Frequently Asked Questions
Did upadacitinib cure alopecia areata?
No. Upadacitinib produced substantial hair regrowth in many participants during treatment. The trials did not establish permanent remission or show that regrowth persists after treatment stops.
How many participants responded to upadacitinib?
At week 24, 44.6% to 45.2% receiving 15 mg and 54.3% to 55.0% receiving 30 mg reached the SALT ≤20 endpoint, corresponding to 20% or less scalp-hair loss. Placebo response was 1.5% in UP-AA1 and 3.4% in UP-AA2 (Mostaghimi et al., 2026).
Did everyone regrow all their hair?
No. Approximately 55% receiving 15 mg and 45% receiving 30 mg did not reach the primary endpoint at week 24. The primary endpoint itself also permitted up to 20% residual scalp-hair loss.
Was upadacitinib tested in teenagers?
Yes. The trials included 118 adolescents aged 12 to 17 years. Their results supported the overall efficacy findings, but the subgroup was too small to precisely characterize uncommon risks (Mostaghimi et al., 2026).
Is upadacitinib safer than other JAK inhibitors?
These trials cannot answer that question. Upadacitinib was compared with placebo rather than another JAK inhibitor, and the placebo-controlled findings cover only 24 weeks.
Is upadacitinib FDA approved for alopecia areata?
No. As of August 2026, alopecia areata is not listed among the FDA-approved indications in the current Rinvoq prescribing information (FDA, 2026).
Would upadacitinib need to be taken indefinitely?
That is unknown. The published trials do not establish the required duration of upadacitinib treatment or what happens after withdrawal. Separate baricitinib research found substantial loss of treatment benefit after withdrawal, but those findings cannot be assumed to apply to upadacitinib (King et al., 2024).
Final Thoughts
The UP-AA trials provide strong short-term evidence that upadacitinib can produce substantial scalp, eyebrow, and eyelash regrowth in many adults and adolescents with severe alopecia areata.
The efficacy findings were closely consistent across two Phase 3 replicate trials, with the 30 mg dose producing the greatest response.
Important questions remain. Approximately half of treated participants did not reach the primary endpoint, long-term durability and uncommon risks are not established by the 24-week findings, and the trials did not compare upadacitinib directly with an approved alopecia treatment.
The most accurate conclusion is that upadacitinib is a promising investigational treatment for severe alopecia areata supported by strong short-term Phase 3 efficacy data. Its eventual clinical role will depend on regulatory review, longer-term safety and durability data, and evidence clarifying how it compares with established treatments.
References
ClinicalTrials.gov. (2026). A study to evaluate the safety and effectiveness of upadacitinib tablets in adult and adolescent participants with severe alopecia areata (NCT06012240). U.S. National Library of Medicine. Retrieved August 28, 2026, from https://clinicaltrials.gov/study/NCT06012240
King, B., Ko, J., Kwon, O., Vañó-Galván, S., Piraccini, B. M., Dutronc, Y., Yu, G., Liu, C., Somani, N., Ball, S., & Mesinkovska, N. A. (2024). Baricitinib withdrawal and retreatment in patients with severe alopecia areata: The BRAVE-AA1 randomized clinical trial. JAMA Dermatology, 160(10), 1075–1081. https://doi.org/10.1001/jamadermatol.2024.2734
Mostaghimi, A., Gooderham, M. J., Lynde, C., Sinclair, R., King, B., Hordinsky, M., Rudnicka, L., Guttman-Yassky, E., Serrao, R., Ohyama, M., Zhang, X., Magnolo, N., Kwon, O., Oddi, C., Meerwein, S., Soliman, A. M., Bu, X., Duan, C., Wu, T., . . . Passeron, T. (2026). Upadacitinib for severe alopecia areata in adults and adolescents: Two Phase 3 UP-AA randomized clinical trials. JAMA Dermatology. Advance online publication. https://doi.org/10.1001/jamadermatol.2026.2853
U.S. Food and Drug Administration. (2022). Olumiant (baricitinib) supplement approval (NDA 207924/S-007). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207924Orig1s007ltr.pdf
U.S. Food and Drug Administration. (2022, June 13). FDA approves first systemic treatment for alopecia areata. https://www.fda.gov/news-events/press-announcements/fda-approves-first-systemic-treatment-alopecia-areata
U.S. Food and Drug Administration. (2023). Drug Trials Snapshots: Litfulo. https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-litfulo
U.S. Food and Drug Administration. (2024). Drug Trials Snapshots: Leqselvi. https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-leqselvi
U.S. Food and Drug Administration. (2026). Rinvoq (upadacitinib) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218347Orig1s008,211675Orig1s034lbl.pdf
Disclosure
The author declares no financial, professional, or personal conflicts of interest related to this article. No external organization funded or influenced its preparation.
