Keep Hair

Updated June 2026. Originally published August 2019.

Are there any proven hair loss treatments? What are the latest advances for regrowing hair?

To start, how much hair do you have? People have between 100,000 and 150,000 hairs on their head. The number of strands normally lost in a day varies but on average is 100. Young people regrow this hair quickly. However, by age 50, pattern hair loss affects about half of males and a quarter of females — and by age 70, research suggests up to 80% of men and 50% of women experience some degree of androgenetic alopecia (AGA).

Keeping healthy hair may not be critical for your survival or physical health, but it is part of making you feel good each time you look in the mirror and contributes to your sense of wellbeing. Until very recently, the pharmaceutical options for pattern hair loss were essentially frozen since 1997 — two FDA-approved treatments, neither transformative. That is now changing in ways worth paying attention to.

What actually works: the established options

Topical minoxidil

Topical minoxidil (Rogaine and generic) remains the most accessible and best-evidenced over-the-counter option. When applied to the scalp, it stimulates hair follicles and pushes more hair into the growing phase. A 2017 review in the Journal of the American Academy of Dermatology found that men using the 5% topical twice daily had an average increase of nearly 15 hairs per square centimeter. A 2018 study found it reduced loss in about 50% of men, but only a small percentage achieved significant new growth. Benefits disappear if you stop using it.

Effectiveness varies considerably between individuals due to differences in follicular sulfotransferase (SULT1A1) enzyme activity — people with low enzyme expression in the scalp respond poorly to topical minoxidil regardless of how consistently they use it.

Low-dose oral minoxidil — a significant development since this article was first published

One of the most meaningful practical developments in hair loss treatment in recent years is the emergence of low-dose oral minoxidil (LDOM) as an off-label option. Originally an antihypertensive medication, minoxidil at doses of 0.25–5 mg daily — far below the blood-pressure doses of 10–40 mg — has accumulated a meaningful evidence base for hair loss across multiple types of alopecia, including androgenetic alopecia in both men and women.

In January 2025, 43 hair loss specialists from 12 countries published an international consensus statement in JAMA Dermatology providing guidance on LDOM prescribing. A 2025 Frontiers in Pharmacology review summarizing the evidence concluded that oral minoxidil provides systemic exposure effective even in topical non-responders with low SULT1A1 activity.

LDOM’s main advantages over topical are convenience (once daily, no scalp application) and effectiveness in people who don’t respond to the topical form. Its main disadvantages are its off-label status, the need for medical supervision, and a side effect profile that includes hypertrichosis (unwanted body hair growth, particularly in women, affecting roughly 15% of patients) and, less commonly, fluid retention. Blood pressure effects at doses ≤5 mg are minimal in people with normal hemodynamics, but medical oversight before starting remains important.

LDOM is not FDA-approved for hair loss — it requires a prescription and a doctor willing to prescribe off-label. But its evidence base and practical utility have grown enough that many dermatologists now consider it alongside topical minoxidil as a first-line option, particularly for patients who find topical application inconvenient or who have demonstrated poor topical response.

Finasteride — important safety updates

Oral finasteride (1 mg daily, FDA-approved 1997) remains effective for male pattern hair loss, with studies showing 48% of men experienced hair regrowth after one year and 66% after two years, compared to 7% on placebo. It is not approved for women of childbearing potential due to teratogenicity risk.

Since this article was first written, the safety picture for finasteride has become materially clearer and more concerning. Key regulatory updates:

• FDA (2022): Added suicidal ideation and behavior to the listed adverse reactions for finasteride based on patient reports.
• FDA (April 2025): Issued a safety alert on compounded topical finasteride — widely offered through telemedicine hair loss platforms — citing serious adverse events including persistent sexual dysfunction, mood changes, and depression from unapproved formulations of inconsistent quality.
• EMA (May 2025): Following an EU-wide pharmacovigilance review, formally confirmed that suicidal ideation is a recognized side effect of oral finasteride, mandated updated product labeling, and required patient risk cards in all finasteride 1 mg packaging.

These are serious additions to finasteride’s risk profile — not reasons to panic if you’re currently using it without problems, but important context for anyone starting it or buying it through a telemedicine service. Sexual dysfunction, depression, and mood changes occur in fewer than 2% of patients on the oral approved dose and are typically reversible upon discontinuation — but the EMA’s 2025 review acknowledged that some sexual dysfunction may persist after stopping. The compounded topical formulations carry additional risk because their quality and absorption are not regulated. If you currently use a compounded topical finasteride spray from an online platform, this is worth raising with your dermatologist.

The biggest development in three decades: Breezula (clascoterone)

In December 2025, Cosmo Pharmaceuticals announced topline results from two large pivotal Phase 3 trials — Scalp 1 and Scalp 2 — testing clascoterone 5% topical solution (Breezula) for male androgenetic alopecia. Across 1,465 patients in both studies, clascoterone delivered statistically significant improvements in target-area hair count (TAHC) compared to placebo: a 539% relative improvement in one study and 168% in the other. Side effects were comparable to the placebo vehicle.

This matters because clascoterone works through a fundamentally different mechanism than any currently approved hair loss treatment. Rather than reducing DHT production body-wide the way finasteride does, clascoterone blocks DHT at the androgen receptor directly in the hair follicle, which means it acts locally without significantly affecting systemic DHT levels. For patients who want to avoid finasteride’s hormonal side effects, this represents a potentially important alternative.

The current status as of June 2026: Cosmo completed the required 12-month safety follow-up in spring 2026 and filed for regulatory approval in both the US and EU. If approved on schedule, first approvals could come by mid-2027, marking the first new approved mechanism of action for pattern hair loss in nearly 30 years. The full peer-reviewed trial data has not yet been published, so the absolute hair count changes (as opposed to relative improvement vs. placebo) remain to be confirmed — a caveat worth keeping in mind before getting too excited.

One important note on the existing clascoterone product: a 1% clascoterone cream called Winlevi is already FDA-approved for acne. Breezula for hair loss uses a 5% solution formulation; Winlevi’s dose and delivery are different enough that using it off-label on the scalp is not equivalent and not recommended.

A genuine breakthrough for a different type of hair loss: JAK inhibitors for alopecia areata

The hair loss revolution since 2022 has largely bypassed androgenetic alopecia (male and female pattern hair loss) and instead transformed treatment for alopecia areata (AA) — an autoimmune condition in which the immune system attacks hair follicles, causing patchy or total hair loss. It affects roughly 2% of the global population and was historically very difficult to treat.

Three Janus kinase (JAK) inhibitors now hold FDA approval for severe alopecia areata:

• Baricitinib (Olumiant) — approved June 2022 (Eli Lilly), for adults with severe AA.
• Ritlecitinib (Litfulo) — approved June 2023 (Pfizer), for adults and adolescents aged 12 and older with severe AA. The first and only treatment approved for patients as young as 12.
• Deuruxolitinib (Leqselvi) — approved July 2024 (Sun Pharma), for adults with severe AA.

All three suppress the JAK-STAT signaling pathway that drives the autoimmune attack on hair follicles. In Phase 3 trials, baricitinib produced significant hair regrowth in 35–40% of patients over 36 weeks. Ritlecitinib showed comparable efficacy in a broader age range.

These are prescription-only treatments for a specific diagnosis — they are not appropriate for standard pattern hair loss. All three carry an FDA boxed warning for class-wide risks including serious infections, malignancy, and cardiovascular events, though Phase 3 trial data in AA populations have not shown unexpected safety signals at the doses used. Anyone with alopecia areata who has struggled to find effective treatment should ask a dermatologist specifically about these options.

Hair Loss Treatment Topical Creams

Beyond Breezula and the established options above, several other topical approaches are in development or have been discontinued since this article was first written:

1. Vegamour, a vegan hair-care company, claims their Gro Hair Serum provides benefits above minoxidil. Their evidence base remains a small, unpublished independent trial — unchanged from the original review.
2. Follicum / Coegin Pharma: Follicum’s topical FOL-005 solution showed only marginally better results than placebo in Phase 2 (7 vs. 6 hairs per square centimeter). Coegin Pharma, which acquired Follicum, pivoted toward hair coloring treatments using Follicum technologies rather than pursuing further efficacy trials.

Hair Loss Treatment Stem Cell Regeneration and Scalp Injections

Monthly platelet-rich plasma (PRP) injections into the scalp remain somewhat effective for some patients but require ongoing commitment, and the evidence base for long-term benefit remains mixed.

Stemson Therapeutics, mentioned in Keep.Health’s Cellular Reprogramming article, was developing induced pluripotent stem cell (iPSC)-derived hair follicle germs for hair regeneration and had raised over $7 million. The company has since wound down operations — a reminder that early-stage regenerative approaches face significant obstacles between promising preclinical results and commercial viability.

Shiseido’s earlier autologous cell-based therapy program, pursued by Dr. Jiro Kishimoto using dermal sheath cup cells, also did not advance to market.

The Columbia University 3D-printed hair follicle research from 2019 remains a laboratory proof-of-concept without clinical translation to date.

Laser and Light Hair Loss Treatments

Laser and red-light treatments remain heavily marketed. Effects are modest, tend to work better for thinning hair than complete baldness, and require consistent long-term use. The landscape of specific products has not changed substantially since this article was first written. Approach online reviews with caution — many appear fake or unverifiable.

Capillus — Laser therapy cap (6 minutes per day). Minimal and questionable efficacy studies.

HairMax — FDA-cleared medical grade laser headband. Available for home use on Amazon. 90-second treatments, 3 times per week. Offers a money-back guarantee that is reportedly difficult to redeem if purchased through Amazon.

iRestore — Helmet combining lasers and LEDs. Claims 43.2% increase in hair count in 4 months with the Essential model. Recommend using with other products simultaneously, making it hard to attribute results to the device. Money-back guarantee is not valid if purchased through Amazon.

Theradome — FDA-cleared helmet. Clinically tested in a 2016 trial. Claims 98% satisfaction rate across 70 million treatments. 20 minutes per week; thicker hair reportedly in 6–8 weeks and new hair in 4–6 months.

Lumenis Folix — FDA-cleared fractional laser for Fitzpatrick skin types 1–4. 3–6 treatments every 4 weeks; claimed 10–18% increase in hair growth area coverage. Trial results unpublished.

Other Drugs and Approaches

1. Way316606 is an osteoporosis drug that also causes hair growth, available in Italy. Customer reviews remain negative.
2. Biohacker Brian Johnson continues to use a multi-intervention approach with some reported success. His hair loss video is worth watching for anyone curious about stacking approaches.

Hair Loss Treatment Conclusion

The hair loss treatment landscape has genuinely changed since this article was first published — more in the past three years than in the preceding two decades. The JAK inhibitor approvals represent a real breakthrough for alopecia areata. Breezula’s Phase 3 results, if confirmed in full peer-reviewed publication and followed by regulatory approval, would represent the first new mechanism for pattern hair loss since the 1990s. And low-dose oral minoxidil has emerged as a practical option that many dermatologists now consider alongside the traditional topical.

Keep.Health will continue to monitor progress. For ongoing coverage of the development pipeline and clinical trials, FollicleThought and HairLossCure2020 remain the best independent tracking resources.

Before starting any treatment, it is a good idea to:

1. Consult with a dermatologist or trichologist to determine the cause of hair loss — the right treatment depends on the type of hair loss, which varies.
2. Ask specifically about low-dose oral minoxidil if topical hasn’t worked or if application is inconvenient.
3. Discuss the updated finasteride safety data if you are starting or currently using finasteride or any compounded topical formulation.
4. Consider your budget and long-term commitment, as most treatments require indefinite use to maintain results.