Future research must address dose optimization, delivery vehicle design (e.g., extracellular vesicle encapsulation), and long-term safety profiles to transform these mechanistically robust approaches into standardized, cost-effective therapies. Such advances will position preconditioned ADSCs as a next-generation platform for personalized alopecia management. Hers, a telehealth company that provides online health care services and products for women, announced the launch of its Biotin-plus-Minoxidil Gummy, the first-of-its-kind prescription gummy formulated to support hair regrowth. Available through forhers.com, this gummy combines prescription-strength minoxidil, the only FDA-approved ingredient for female hair loss, with biotin, a popular vitamin for supporting healthy skin, hair and nails. Minoxidil is clinically proven to regrow thicker, fuller hair in three to six months (based on studies of oral minoxidil up to 2.5 mg per day at various doses).
FDA approves 1st treatment that can grow back hair for teens with severe alopecia areata
You have about 5 million hair follicles on your body, and more than 100,000 of them, on average, are located on your scalp. At any given time, 90% of the follicles on your head are growing while the other 10% are in a resting phase where new hairs aren’t sprouting, Anthony Oro, MD, PhD, the Eugene and Gloria Bauer Professor of Dermatology at Stanford Health Care, tells SELF. Throughout your life, your hair goes through this growth cycle every two to six years (which is why some people are able to grow their hair all the way down to their waist). Laser hair therapy, more commonly referred to as low-level laser therapy or LLLT, involves the use of FDA-approved laser hair growth devices. The FDA has approved laser comb, brush cap, helmet, and a hood-type devices that people can wear or apply to their head.
Hair Regrowth Serums
Zhao et al. found that ADSCs inhibit the proliferation and differentiation of natural killer (NK) cells and T cells, reducing their cytotoxic effects. At the same time, they suppress B cell maturation and antibody production, weakening the inflammatory response and protecting hair follicles from damage 51. These findings not only deepen our understanding of the role of ADSCs in immunomodulation but also provide new perspectives and strategies for disease treatment and regenerative medicine. The FDA has followed highly promising results from trials demonstrating the hair regrowth potential of a common arthritis drug with a landmark approval, giving baricitinib the green light as a treatment for severe alopecia areata. The move makes the drug the first ever FDA-approved drug for systemic treatment of the disease, and will take the form of a daily pill that proved hugely promising in recent Phase 3 trials.
MORE: Will Smith, Chris Rock confrontation at Oscars puts spotlight on alopecia, a condition that affects millions
Tofacitinib and ruxolitinib were among the first JAK inhibitors to be used off-label in treatment of AA 39, 40. Oral tofacitinib is currently FDA-approved for multiple rheumatologic and gastroenterologic autoimmune diseases 41. Oral ruxolitinib is FDA-approved for myelofibrosis, polycythemia vera, and graft-versus-host disease 42, 43. The Food and Drug Administration on Monday approved a drug called baricitinib as the first for treating severe alopecia areata, an autoimmune disorder affecting more than 300,000 people in the United States every year.
Regulation of the hair follicle cycle by ADSCs
- Oral ruxolitinib is FDA-approved for myelofibrosis, polycythemia vera, and graft-versus-host disease 42, 43.
- Ritlecitinib similarly reported 23% of patients achieving a SALT score ≤ 20 at week 24.
- Now, a new wave of ingredients is cropping up in popular hair growth shampoos, conditioners, serums, and more—backed by growing research.
- The drug, which is called Litfulo (with the generic name ritlecitinib), is the first and only FDA-approved alopecia drug for kids 12 and up, in addition to adults.
- Comparative trials reveal SVF’s superiority over fat grafting alone, with SVF-enriched fat injections driving superior anagen-phase progression and follicular reactivation 84.
- “Over 24 weeks of treatment, about 30% of people participating in the trials regrew their hair. Remember, these are patients who at the start had 50% to 100% scalp hair loss. Often they had no scalp hair,” King told ABC News.
It is currently in phase 2 clinical trials to evaluate safety and efficacy, and a case report has shown improvement in AU by SALT score 75. Baricitinib was the first JAK inhibitor approved in June 2022 after pivotal trials demonstrated its efficacy in adults with severe AA 13. This approval was followed by ritlecitinib in June 2023 for patients aged ≥ 12 years 13.
Dermatologists often use steroid injections like triamcinolone to address scalp inflammation caused by alopecia areata, or prescribe oral medications like spironolactone to help reduce hormone-related hair loss. Meanwhile, minoxidil is widely considered one of the most effective over-the-counter treatments for various types of hair loss. The Food and Drug Administration on Monday approved an Eli Lilly drug that is the first-ever treatment for alopecia areata, an autoimmune disorder that triggers sudden hair loss.
Temporary Fixes and Other Options
The condition has come to the fore recently through high-profile cases including Hollywood actress Jada Pinkett Smith and congresswoman Ayanna Pressley. The Times points out that fda approves first drug to treat hair loss caused by alopecia FDA approval plays an important role in getting insurance companies to cover the costs of drugs, adding that Janus kinase inhibitors have a list price of nearly $2,500 a month. Around 45 percent of people in the higher dose group also saw significant eyebrow and eyelash regrowth. Baricitinib, which is made by U.S. pharmaceutical company Eli Lilly and known by the trade name Olumiant, belongs to a class of drugs called Janus kinase inhibitors. The condition has come to the fore recently through high-profile cases including Hollywood actress Jada Pinkett Smith and Rep. Ayanna Pressley. Both 8 mg and 12 mg doses helped patients achieve a SALT score of 20 or less in just 24 weeks.
- Minoxidil has been helping hair growth since 1987, offering options like 2% or 5% solutions for different needs.
- Autologous adipose-derived stromal vascular cell (ADSVC) therapy significantly boosted hair regeneration in alopecia areata (AA), with marked improvements in density and shaft thickness at 3–6 months, particularly among female patients 83.
- She has a special interest in treating hair loss, psoriasis, and skin cancer.
- Williams does not recommend transplants, because alopecia areata is an autoimmune disorder.
- Two-milligram doses, meanwhile, also brought improvements in scalp hair coverage in almost a fifth of patients.
Measurable systemic levels of tofacitinib were detected using 2% ointment, suggesting systemic absorption does occur, albeit to a negligible degree compared to oral formulations 63. Currently, data on the pharmacokinetics of topical tofacitinib are significantly limited compared to its oral formulation. Many popular and brand-name serums seek to address hair loss or thinning hair on other parts of the body.
FDA-Approved Hair Loss Treatments
Ivarmacitinib, a JAK3 selective inhibitor, has recently undergone a phase 2 clinical trial in which it has demonstrated efficacy in AA 73. Jaktinib, a novel JAK1 and JAK2 inhibitor, has been evaluated in severe AA via an open-label phase 2 study; the results have still not been made publicly available 74. Deucravacitinib, a selective tyrosine kinase 2 (TYK2) inhibitor, is FDA approved for treatment of plaque psoriasis but has also shown promise in AA.
After 28 weeks of treatment on the scalp and face, 75% of patients treated with topical tofacitinib reported partial hair regrowth based on subjective clinical observation 64. This is in comparison to 31% of patients who experienced regrowth with 1% ruxolitinib, 63% of patients who exhibited partial regrowth with topical clobetasol dipropionate 0.005%, and no regrowth observed in placebo-treated patients 64. These data are difficult to interpret given the weak outcome measures in this study. Long-term data remain to be collected; however, relapse rates have been demonstrated to be relatively high in the oral formulation, as described above.
However, current treatment options for alopecia are often constrained by limited efficacy and notable adverse effects. This underscores an urgent need for innovative therapeutic strategies to address these gaps. Adipose-derived stem cells (ADSCs), a subset of mesenchymal stem cells, represent a promising new approach in the treatment of alopecia.