In this article
The new hair loss treatments to follow in 2026 are PP405, a topical gel in a Phase 2/3 trial; clascoterone 5% topical solution, whose Phase III program Cosmo reported complete in July 2026, with a US filing planned for early 2027; and VDPHL01, an oral investigational drug in Phase 3. None of the three is FDA approved for hair loss in the sources checked, and none of those sources gives an approval or availability date.[1][4][8]
Source check: October 26, 2026. A dated research snapshot, not medical advice or a treatment ranking.
- PP405 0.05% topical gel is in the AWAKEN Phase 2/3 trial in adult men, which ClinicalTrials.gov listed as recruiting, with estimated primary completion in December 2027.[1]
- Cosmo reported its clascoterone 5% Phase III program for male pattern hair loss complete in July 2026 and projected a US submission in the first quarter of 2027.[4]
- VDPHL01, an oral extended-release tablet from Veradermics, is in Phase 3 Study 304 in men, and the sponsor still describes it as investigational.[6][8]
- According to the American Academy of Dermatology, finasteride is FDA approved for male pattern hair loss, and minoxidil can help early hair loss when used as directed.[7]
- The American Academy of Dermatology says diagnosis comes first, because androgenetic alopecia, alopecia areata and other causes of hair loss call for different treatments.[7]
Which treatments have human trial programs?
Three new hair loss treatments have active or recently completed human trial programs in 2026: PP405, clascoterone 5% solution and VDPHL01. All three target androgenetic alopecia, also called male pattern hair loss or AGA, and each is at a different stage of development.
The table separates a trial record from a sponsor announcement. It covers three examples, not every hair-loss treatment under investigation. Read each population and endpoint before interpreting its headline number.
Hair loss has different causes. The American Academy of Dermatology describes diagnosis as the starting point for selecting treatment; a search for the newest product does not establish the cause of an individual's hair loss.[7]
| Candidate | Human-study stage in the checked source | What the record does not establish |
|---|---|---|
| PP405 topical gel[1] | AWAKEN Phase 2/3, recruiting; registry updated October 22, 2026.[1] | The estimated 600-person enrollment is a target, not a completed results population.[1] |
| Clascoterone 5% topical solution[4] | Cosmo reported its Phase III program complete in July 2026.[4] | Projected 2027 regulatory submissions are not approvals or launch dates.[4] |
| VDPHL01 oral investigational drug[6] | Study 304 is registered as Phase 3; its record was last updated February 12, 2026.[6] | That registry record predates the sponsor's October results announcement.[8] |
How do the new hair loss treatments work?
The three candidates take different routes to the hair follicle. Two are applied to the scalp and one is taken by mouth, and each sponsor describes a different target.
PP405: a follicle stem cell approach
Pelage Pharmaceuticals describes PP405 as a topical therapy designed to reactivate dormant hair follicle stem cells, which it says are retained even in balding scalps. Pelage says the technology is rooted in stem cell research from UCLA. In AWAKEN, the product is a 0.05% topical gel compared with a vehicle gel.[1][2]
Clascoterone 5%: a topical androgen receptor inhibitor
Clascoterone is a topical androgen receptor inhibitor. The same molecule is already approved at a lower strength as an acne cream, and Cosmo is studying a separate 5% solution for male pattern hair loss. The hair-loss formulation has not been approved.[3][4]
VDPHL01: an oral extended-release tablet
The Study 304 registry lists VDPHL01 as an extended-release tablet compared with placebo in men with androgenetic alopecia. Veradermics describes it as investigational. The full mechanism and dosing details were not available in the sources checked, so they are not described here.[6][8]
What did PP405 studies measure?
Pelage's June 17, 2025 Phase 2a announcement describes 78 men and women with androgenetic alopecia, four weeks of scalp application and follow-up through week 12. Hair-growth measures were exploratory; safety and pharmacokinetics were the primary and secondary endpoints.[2]
At week eight, the sponsor reported a greater-than-20% hair-density increase in 31% of treated men with a higher degree of hair loss, versus 0% in the corresponding placebo group. The announcement does not state that subgroup's denominator. This is not a response rate for all 78 participants, for women, or for the later AWAKEN study.[2]
AWAKEN's primary measure is the change in non-vellus target-area hair count at week 24. Its registry gives an actual start of September 21, 2026, and estimated primary completion in December 2027. The record had no posted results when checked.[1]
The AWAKEN registry limits enrollment to men aged 18 to 55, even though the Phase 2a study included women. Results from AWAKEN will therefore describe adult men, not women with female pattern hair loss.[1]
What do the clascoterone results and filing dates mean?
Cosmo's April 15, 2026 release describes SCALP 1 and SCALP 2, which enrolled 1,465 men across 51 centers. The initial randomized, vehicle-controlled phase lasted six months. The subsequent six-month extension selected men who responded on a patient-reported survey and re-randomized them to continued treatment or vehicle.[3]
Cosmo reported a 2.39-fold improvement in target-area hair count for continuous treatment versus switching to vehicle after six months. The release does not provide the extension's analyzed sample size or absolute group changes. A relative comparison in selected responders is not an absolute hair count or a result for every enrolled man.[3]
On July 23, 2026, Cosmo projected a US submission in the first quarter of 2027 and a European submission in the second quarter of 2027. These are the company's filing plans, not regulator decisions or promised pharmacy availability.[4]
What is known about VDPHL01 Study 304?
The Study 304 registry describes a randomized, placebo-controlled oral-drug trial in men with androgenetic alopecia. Its estimated enrollment is 480. Primary measures include six-month change in non-vellus target-area hair count and a participant-reported treatment-benefit assessment. The record lists no posted results.[6]
Veradermics' homepage lists an October 19, 2026 Study 304 results announcement and still describes VDPHL01 as investigational. The full linked release was inaccessible during this source check. Numerical results from that announcement are therefore not reproduced here; absence of registry results must not be mistaken for absence of a sponsor announcement.[8]
The registry lists men aged 18 to 65 as eligible. Like AWAKEN, Study 304 will not by itself describe results in women.[6]
When could new hair loss treatments be available?
No checked source gives a launch date for any of the three candidates. The nearest public milestones in 2026 and 2027 are a planned US filing for clascoterone 5%, a sponsor results announcement for VDPHL01 and the estimated completion of the AWAKEN trial for PP405.[1][4][8]
A filing starts an FDA review; it is not an approval. The table lists only what each source states, so read the dates as company or registry estimates.
| Candidate | Form | Population in the checked record | Next public milestone |
|---|---|---|---|
| PP405 | 0.05% topical gel | AWAKEN: men aged 18 to 55, estimated 600 participants | Estimated primary completion in December 2027[1] |
| Clascoterone 5% | Topical solution | SCALP 1 and SCALP 2: 1,465 men | Projected US submission in the first quarter of 2027[3][4] |
| VDPHL01 | Oral extended-release tablet | Study 304: men aged 18 to 65, estimated 480 participants | Sponsor results announcement listed for October 19, 2026[6][8] |
What hair loss treatments are available now?
While the new candidates move through trials, dermatologists use treatments that are already available. According to the American Academy of Dermatology, finasteride is FDA approved to treat male pattern hair loss, and minoxidil applied to the scalp can help early hair loss but cannot regrow an entire head of hair.[7]
The academy also lists spironolactone as an option for some women with female pattern hair loss, along with laser devices, microneedling and platelet-rich plasma. For severe alopecia areata, an autoimmune cause of patchy hair loss, the FDA approved the oral JAK inhibitor baricitinib in 2022.[7][9]
Platelet-rich plasma (PRP), low-level laser therapy (LLLT) and exosome therapy are offered in many clinics as cash-pay procedures, and the evidence for them is thinner and less consistent than for the approved drugs. The hair loss treatment guide compares these options, and the low-level laser therapy overview explains how light-based devices are used. Exosome products for hair are not FDA approved; the post on exosome therapy for hair loss covers what is and is not known.
What should you ask about a new hair-loss treatment?
Ask the provider to name the exact product or procedure, identify the diagnosis being discussed, and show the source for any approval claim. Ask whether a quoted result came from all participants or a selected subgroup, and whether it measures hair count, density or a participant questionnaire.
For a proposed research appointment, ask for the trial identifier, the participating site and the current enrollment information. For an ordinary clinic visit, ask who would provide the service and what the consultation covers. These questions do not establish eligibility for a trial or suitability for a treatment.
A short checklist helps when a clinic or website describes a new treatment:
- Confirm the diagnosis, ideally with a board-certified dermatologist, before comparing products.
- Look up the ClinicalTrials.gov identifier for any trial mentioned, such as NCT07819435 for AWAKEN or NCT06972264 for Study 304.
- Check whether the product is approved for hair loss, approved for another use, or still investigational.
- Ask what is measured and when: hair count at 24 weeks is a different result from a questionnaire at six months.
Where can you compare PRP Therapy clinic records?
PRP is a separate procedure, not one of the investigational drugs above. The American Academy of Dermatology describes drawing blood, separating its components and injecting the plasma into the area with hair loss.[7]
PRP for hair is usually cash pay, and providers include dermatologists, hair restoration physicians and aesthetic clinics. The platelet-rich plasma treatment guide explains the procedure in more depth, and PRP for hair loss covers what studies of scalp injections report.
Regenerated.com's September 2026 export contains 2,082 records listing PRP Therapy among 9,042 published US clinic records, across 48 states plus DC. Source: Regenerated.com clinic export, collected September 2026. This measures directory coverage, not hair-specific services or access to PP405, clascoterone or VDPHL01.
Use the PRP Therapy clinic directory for the recorded service category. State-level records are available for PRP Therapy in Colorado, PRP Therapy in Indiana and PRP Therapy in Minnesota. Confirm the proposed procedure and location with each provider rather than treating category membership as a hair-loss recommendation.
Two records listing PRP Therapy are IV Theory in Boca Raton and Dr. James Hair Restoration and PRP in Ventnor City. These links identify directory records, not verified current services, trial sites or endorsements. Ask explicitly whether the clinic evaluates hair loss and what it offers.
Listing order in the directory is not paid ranking, Featured slots are labeled and capped, and Verified means a clinic passed credential checks, not that it paid. Regenerated.com is free for patients, and inclusion is not an endorsement. The guide to Featured, Verified and organic listings explains each label, and the national list of PRP clinics is the place to start a search by state or city.
Frequently asked questions
What is the newest hair loss treatment in 2026?
The newest hair loss treatments in 2026 are investigational: PP405 topical gel in the AWAKEN Phase 2/3 trial, clascoterone 5% topical solution after a completed Phase III program, and oral VDPHL01 in Phase 3 Study 304. None is FDA approved for hair loss in the sources checked on October 26, 2026. Approved options today include finasteride for male pattern hair loss and minoxidil, according to the American Academy of Dermatology.[1][4][7]
Is a PP405 trial completion date a release date?
No. AWAKEN lists December 2027 as estimated primary completion. That is a trial milestone, not a retail release date, and the registry had no posted results at the October 26, 2026 check. After a trial ends, a sponsor still has to analyze results, file an application and wait for an FDA decision, so a completion date says nothing certain about when a pharmacy could stock PP405.[1]
Is clascoterone's acne product the same as its hair-loss program?
No. Cosmo distinguishes its approved acne product, Winlevi, from the 5% topical solution studied for male pattern hair loss. Approval of the acne product does not establish approval of the hair-loss formulation. The hair-loss solution uses a higher strength, was tested in its own SCALP 1 and SCALP 2 trials, and Cosmo projects its US submission for the first quarter of 2027.[3][4]
Does no posted registry result mean VDPHL01 has no announced results?
No. The retrieved Study 304 registry contained no results, while Veradermics' homepage listed an October 19, 2026 results announcement. Registry reporting and company announcements are different records. The inaccessible announcement's numerical findings are not assessed here. Sponsors often announce topline findings before results appear on ClinicalTrials.gov, so check both records and read any announcement for its population and endpoints.[6][8]
Does a PRP listing show that a clinic supplies the new drugs?
No. The directory count describes records tagged with PRP Therapy, not availability of an investigational drug, participation in research or hair-specific expertise. Confirm the named service, clinician and location directly before interpreting a listing as an available appointment. Investigational drugs such as PP405 and VDPHL01 are only given inside registered trials, at sites named in the trial record, not through ordinary clinic visits.
Can women use the new hair loss treatments?
Not yet in the late-stage trials checked here. AWAKEN for PP405 and Study 304 for VDPHL01 enroll only men, and the clascoterone SCALP trials enrolled men. The earlier PP405 Phase 2a study did include women. For female pattern hair loss today, the American Academy of Dermatology lists minoxidil and, for some women, spironolactone, chosen after a dermatologist confirms the diagnosis.[1][2][6][7]
Sources
- ClinicalTrials.gov: PP405 AWAKEN, NCT07819435. Checked October 26, 2026.
- Pelage: PP405 Phase 2a results, June 17, 2025. Checked October 26, 2026.
- Cosmo: clascoterone 12-month results, April 15, 2026. Checked October 26, 2026.
- Cosmo: development and submission update, July 23, 2026. Checked October 26, 2026.
- ClinicalTrials.gov: VDPHL01 Study 304, NCT06972264. Checked October 26, 2026.
- American Academy of Dermatology: hair loss diagnosis and treatment. Checked October 26, 2026.
- Veradermics: investigational VDPHL01 and October 19, 2026 announcement index. Checked October 26, 2026.
- FDA: supplemental approval letter for baricitinib in severe alopecia areata, NDA 207924/S-007, 2022. Checked November 5, 2026.