Clascoterone & Hair Loss (Breezula): Does It Work, Is It Safe & Can You Get It in London? Phase 3 12-Month Data Explained
Last updated: May 2026 Medically reviewed by the doctors at The London PRP Clinic by The Wellness, Marylebone
Clascoterone 5% topical solution (the investigational hair loss product branded Breezula, made by Cosmo Pharmaceuticals) is the first new mechanism for male pattern hair loss in more than thirty years. Two pivotal Phase 3 trials (SCALP 1 and SCALP 2) in 1,465 men showed statistically significant hair count improvements with a safety profile comparable to placebo, and 12-month follow-up data released on 15 April 2026 confirmed that continuing the drug produces continued hair gain while stopping it leads to regression. Clascoterone is not yet licensed for hair loss anywhere in the world, including the UK. FDA filing is expected in early 2027, with an EMA submission running in parallel. Until then, the proven, available, doctor-led options in London are platelet-rich plasma (PRP), GFC, exosome therapy (ExoRevive), and prescription medication, all of which The London PRP Clinic by The Wellness delivers from its Marylebone and Canary Wharf locations.
Enquire on WhatsApp: Message us about hair restoration | Email: team@thewellnesslondon.com | Call: +44 20 3951 3429
Key takeaways
Clascoterone is a topical androgen receptor inhibitor. It blocks dihydrotestosterone (DHT) at the hair follicle without lowering circulating DHT in the body, which is the mechanism behind finasteride and dutasteride.
Phase 3 SCALP 1 trial: 5.39 times (539%) greater improvement in Target Area Hair Count (TAHC) versus vehicle at 6 months. Phase 3 SCALP 2 trial: 1.68 times (168%) greater improvement versus vehicle. Both reached statistical significance (p<0.05).
12-month data (released 15 April 2026): patients who stayed on clascoterone continued to gain hair through month 12 and achieved a 2.39-fold greater improvement in TAHC than patients who switched to vehicle at month 7. Treatment satisfaction was 24.5% higher than vehicle.
Safety profile: treatment-emergent adverse events were comparable to vehicle. Local application-site reactions were the most common. There is no meaningful systemic absorption at the 5% concentration used.
UK availability for hair loss: not yet. Clascoterone 1% cream (Winlevi) was approved by the MHRA in January 2025 for acne in patients aged 12 and over. The 5% scalp solution is not licensed in any country.
Off-label prescribing of clascoterone for hair loss is theoretically possible in the UK but is not clinically justifiable until the 5% solution is approved and supplied. The 1% acne cream is too low in concentration and the wrong formulation for the scalp.
The proven, available alternatives in London right now include doctor-led PRP (87% success rate at The London PRP Clinic by The Wellness, 32% average density increase), GFC, exosome therapy, oral or topical finasteride, dutasteride, and minoxidil.
PRP and clascoterone are likely to be complementary, not competing. PRP stimulates regrowth via concentrated growth factors. Clascoterone protects against DHT damage. When clascoterone is approved, the optimal protocol will almost certainly combine the two.
Want a personalised hair restoration plan from GMC-registered doctors? Message us on WhatsApp for a free consultation in Marylebone or Canary Wharf.
What is clascoterone?
Clascoterone (chemical name cortexolone 17α-propionate, originally coded CB-03-01) is a topical androgen receptor inhibitor developed by Italian biotech Cassiopea, now owned by Cosmo Pharmaceuticals. The 1% cream formulation has been sold as Winlevi since FDA approval in August 2020 for acne vulgaris in patients aged 12 and over. The MHRA approved Winlevi for the UK market in January 2025. The 5% topical solution being investigated for male pattern hair loss is branded Breezula and is still in regulatory development.
Clascoterone is the first molecule in a new class of hair loss drugs. Until 2026, only two medications had ever been approved by the FDA for androgenetic alopecia: minoxidil (1988) and oral finasteride (1997). Nearly three decades have passed without a new mechanism. Clascoterone is positioned to become the third FDA-approved AGA drug if the planned 2027 New Drug Application (NDA) is successful.
The drug's structure is closely related to dihydrotestosterone (DHT) itself. This similarity allows clascoterone to bind to androgen receptors on the hair follicle, occupying the receptor and preventing DHT from triggering follicle miniaturisation. After binding, clascoterone is rapidly metabolised into cortexolone, an inactive compound, which is why systemic exposure is minimal even at the 5% scalp concentration.
What is Breezula? What is Winlevi? Are they the same drug?
Yes, both are clascoterone, but at different concentrations and formulations.
Winlevi (clascoterone 1% cream): FDA-approved 2020 (US), MHRA-approved January 2025 (UK), for acne vulgaris in patients aged 12+.
Breezula (clascoterone 5% topical solution): investigational, used in the SCALP 1 and SCALP 2 Phase 3 trials for male androgenetic alopecia. Not approved anywhere as of May 2026. FDA NDA filing planned for early 2027.
Some men have tried to repurpose Winlevi 1% cream onto the scalp. This is not recommended. The 1% concentration is five times lower than the dose used in the Phase 3 trials, the cream formulation is designed for facial skin not scalp follicle penetration, and there is no published evidence of efficacy at the 1% concentration for hair regrowth. Hair restoration outcomes from any off-label Winlevi use should be treated as unproven.
How does clascoterone work for hair loss?
Male pattern baldness (androgenetic alopecia, AGA) is driven by genetically inherited sensitivity to dihydrotestosterone. DHT is produced when 5-alpha reductase converts testosterone in scalp tissue. DHT then binds androgen receptors inside the follicle, shortening the anagen (growth) phase and progressively shrinking terminal hairs into thinner vellus hairs. Over years, follicles eventually shut down entirely.
There are three places to interrupt this cascade:
Reduce DHT production in the body. Oral finasteride blocks the type 2 5-alpha reductase enzyme and reduces serum DHT by approximately 70%. Dutasteride blocks both type 1 and type 2 and reduces serum DHT by over 90%.
Reduce DHT production locally in the scalp. Topical finasteride reduces scalp DHT with much less systemic effect than oral.
Block the androgen receptor itself. This is what clascoterone does. DHT levels stay normal, but DHT cannot deliver its signal because clascoterone is occupying the receptor.
The clinical implication: clascoterone offers DHT-blocking benefits at the follicle without lowering systemic DHT. This is the same therapeutic effect men are seeking from finasteride, delivered topically with no meaningful systemic exposure. For men who avoid oral finasteride because of concerns about sexual side effects, mood changes, or post-finasteride syndrome, clascoterone is the most clinically validated alternative on the horizon.
Talk to a hair restoration doctor about your options: WhatsApp +44 7961 280835
What did the Phase 3 SCALP 1 and SCALP 2 trials actually show?
The Phase 3 programme consisted of two identically designed trials, SCALP 1 (NCT05910450) and SCALP 2 (NCT05914805), conducted across 51 study centres in the United States and Europe. A total of 1,465 men aged over 18with mild to moderate male pattern hair loss were randomised to receive either 1.5 ml of clascoterone 5% solution or matching vehicle, applied to the scalp twice daily for six months. This is the largest Phase 3 programme ever conducted for a topical AGA treatment.
The primary endpoint was change in Target Area Hair Count (TAHC) at 6 months versus vehicle. Top-line results were announced by Cosmo on 3 December 2025.
EndpointSCALP 1SCALP 2Patients~733~732Duration (Part 1)6 months6 monthsApplicationTwice dailyTwice dailyRelative TAHC improvement vs vehicle5.39x (539%)1.68x (168%)Statistical significancep<0.05p<0.05Safety vs vehicleComparableComparable
Why the gap between SCALP 1 and SCALP 2? Cosmo has not publicly explained the difference in magnitude between the two trials. Both used identical protocols, identical formulations, and similar populations. Independent commentators have noted that the trials report relative improvement versus vehicle rather than absolute change from baseline, which can amplify the apparent effect size when the vehicle group performs poorly. The honest reading is that clascoterone clearly outperformed placebo to a statistically significant degree in both trials, with one trial showing a much larger margin than the other.
The 12-month data (released 15 April 2026)
After the 6-month double-blind phase, men classified as responders to clascoterone in Part 1 were re-randomised in Part 2 to either continue clascoterone 5% solution for another 6 months or switch to vehicle. The findings, announced on 15 April 2026 by Cosmo, are the most clinically meaningful data released to date.
Continuous treatment kept working. Men who stayed on clascoterone for the full 12 months continued to gain hair through month 12.
Stopping the drug led to regression. Men who switched to vehicle from month 7 onwards lost some of the hair count gains they had built in the first 6 months.
Continuous use produced 2.39 times greater TAHC improvement than the switch-to-vehicle arm at 12 months.
Patient-reported satisfaction was 24.5% higher in the continuous treatment arm than vehicle, a statistically significant difference.
Long-term safety was comparable to vehicle. No new safety signals emerged in the second six months of treatment.
The most important clinical takeaway: clascoterone, like every other proven AGA treatment, requires ongoing use. The drug stabilises and slowly improves the follicular environment while it is in contact with the scalp. When treatment stops, the underlying DHT sensitivity returns, and the hair loss process resumes.
Is clascoterone better than finasteride for hair loss?
There is no head-to-head trial comparing clascoterone 5% solution and oral or topical finasteride. Any direct comparison relies on cross-trial inference, which has significant limitations because patient populations, endpoints, and trial durations differ. With that caveat, here is what the evidence supports.
The clinically honest summary: finasteride remains the most effective and most evidence-backed non-surgical AGA treatment in 2026. It has been used by tens of millions of men with decades of safety data, including long-term studies in men aged 18 to 80. Clascoterone has compelling Phase 3 data but only 12 months of trial follow-up and no real-world data outside the trial setting.
For men who tolerate finasteride well, there is no clinical reason to wait for clascoterone. For men who experience finasteride side effects, or who decline finasteride entirely on principle, clascoterone represents the most plausible future alternative.
Speak to a doctor about whether finasteride, PRP, or a combined approach is right for you: Enquire on WhatsApp
Clascoterone vs minoxidil
Minoxidil is the only other topical hair loss treatment that is licensed and widely available. The two drugs work by completely different mechanisms.
A 2025 ex vivo study using human hair follicle biopsies compared clascoterone 5% to minoxidil 5% and found both increased dermal papilla inductivity and keratinocyte proliferation. Clascoterone reduced IL-6 (a growth-inhibiting cytokine) more than minoxidil in that model. These are laboratory findings and do not translate directly to clinical superiority, but they support the view that clascoterone and minoxidil work on different pathways and are likely to be complementary, not competitive.
Clascoterone vs PRP: which is right for you?
This is the comparison that matters most for patients in London right now, because PRP is available and clascoterone is not.
Clascoterone is a future drug that protects against DHT damage. It is a maintenance therapy designed to slow or reverse the underlying biology of male pattern hair loss. It does not work miracles on follicles that have already shut down.
PRP (platelet-rich plasma) is a regenerative therapy that stimulates the follicle directly. Concentrated growth factors from your own blood (PDGF, VEGF, TGF-β, EGF, FGF) are injected into the scalp, stimulating dormant follicles, prolonging anagen, increasing dermal papilla activity, and improving follicle vascularisation.
FactorClascoterone 5% (when approved)PRP at The London PRP ClinicAvailable in LondonNot yet (expected 2027 or later)Yes, todayMechanismBlocks DHT signal at follicleStimulates follicle with growth factorsBest forSlowing miniaturisationReversing miniaturisation, stimulating dormant folliclesFrequencyTwice daily, ongoingInitial course of 3 sessions, then maintenanceEvidenceOne Phase 3 programme, 12 months43 RCTs, 1,877 patients (Anitua et al., 2025, Dermatology and Therapy)Clinical-trial average168 to 539% TAHC improvement31% average density increase, 70 to 80% successOur clinic outcomesN/A87% success rate, 32% average density increaseSide effectsApplication site irritationMild scalp tenderness for 24 to 48 hoursCost (London PRP Clinic)Not available£545/session, £1,455 for course of 3
The most important point: PRP and clascoterone are not alternatives, they are partners. PRP delivers growth factors that stimulate regrowth from existing follicles. Clascoterone, once available, will protect those follicles from continued DHT damage. The optimal future protocol will almost certainly combine the two, much as the gold-standard medical regimen today combines finasteride (protection) with minoxidil (stimulation).
Find out if PRP is right for your stage of hair loss: Message us on WhatsApp for a free consultation
Is clascoterone available in the UK for hair loss?
No. Clascoterone is not licensed for hair loss in the United Kingdom or in any other country as of May 2026.
The regulatory position is as follows:
Winlevi (clascoterone 1% cream) has been MHRA-approved in the UK since January 2025 for the treatment of acne vulgaris in patients aged 12 and over. It is available on prescription through private dermatology services. NHS access is limited.
Breezula (clascoterone 5% topical solution) completed Phase 3 trials in late 2025 and the 12-month follow-up in April 2026. Cosmo has stated that NDA and MAA (Marketing Authorisation Application) preparations are underway, with a US FDA filing planned for early 2027 and an EMA submission in parallel. The MHRA approved the acne formulation five years after the FDA, so a realistic UK approval timeline for hair loss is 2028 at the earliest, potentially 2029 or later.
The NHS does not fund any medical hair loss treatment for androgenetic alopecia, and there is no indication that this will change for clascoterone. Patients should expect clascoterone, when launched, to be a private prescription product.
Can a private doctor prescribe clascoterone off-label for hair loss in the UK?
In theory yes, in practice no, and we do not recommend it. Off-label prescribing of a licensed medicine is legal in the UK when a doctor judges it clinically appropriate. The General Medical Council (GMC) sets out the conditions in Good Practice in Prescribing and Managing Medicines (2024 update). The doctor must be satisfied there is sufficient evidence to support the use, must explain the unlicensed nature to the patient, and must accept full clinical responsibility.
For clascoterone, this is not currently practical for three reasons:
The 5% scalp solution is not in production for the consumer market. It exists only as investigational supply in the SCALP 1 and SCALP 2 trial sites. There is no commercial route for a UK pharmacy to obtain it.
The 1% Winlevi cream is the wrong product for the scalp. The concentration is five times lower than what was tested in Phase 3, the vehicle is designed for facial skin not scalp follicle delivery, and there is no clinical evidence of efficacy at 1% for hair regrowth.
Specialist-compounded clascoterone solutions sold by some online clinics are unregulated. Concentration, formulation consistency, and contamination control are unknown. The MHRA and the British Association of Dermatologists (BAD) consistently advise against using such products.
The clinically responsible position in May 2026 is to use the evidence-based treatments that are licensed and available (finasteride, dutasteride, topical finasteride, minoxidil, PRP, GFC, exosomes, transplant referral where indicated), to investigate any underlying medical drivers of hair loss (iron, thyroid, vitamin D, hormones), and to revisit clascoterone when an MHRA-approved 5% scalp solution comes to market.
Get a clinical hair loss assessment from a GMC-registered doctor today: WhatsApp +44 7961 280835 | Email:team@thewellnesslondon.com
Where can I get clascoterone in London?
Nowhere clinically appropriate, as of May 2026. The 5% scalp solution that produced the Phase 3 results is not commercially available in the UK. Any clinic claiming to offer "clascoterone for hair loss" is either offering Winlevi 1% acne cream (which is the wrong concentration and formulation for the scalp) or sourcing an unregulated compounded product.
The honest, doctor-led answer: wait for MHRA approval of the 5% scalp solution, and in the meantime build the strongest possible foundation for your hair using the treatments that are licensed, regulated, and proven.
The pathway we recommend at The London PRP Clinic by The Wellness:
Doctor-led diagnostic assessment. Scalp photography, trichoscopy, and blood tests (ferritin, full thyroid panel, vitamin D, B12, hormones, HbA1c, zinc). About 30% of patients we see have a treatable medical driver of hair loss that no amount of clascoterone, finasteride, or PRP will fix until corrected.
First-line medical therapy if appropriate. Oral finasteride, topical finasteride, oral minoxidil, or topical minoxidil, prescribed and monitored by a GMC-registered doctor.
PRP or GFC sessions. Three sessions over three months, with results reviewed at six months. Our documented success rate is 87% with a 32% average density increase.
Add ExoRevive exosome therapy for patients seeking accelerated results or where PRP alone has plateaued.
When clascoterone 5% solution receives MHRA approval, we will be among the first London clinics to offer it as part of an integrated hair restoration protocol. Existing patients will be prioritised for early access and we will publish full clinical guidance for our patient base the moment approval is granted.
Side effects and safety of clascoterone
The published safety data for clascoterone 5% solution comes from the SCALP 1 and SCALP 2 trials and the Winlevi 1% cream label.
Most common adverse events in hair loss trials (reported at rates comparable to vehicle):
Application-site reactions (redness, dryness, itching, scaling)
Mild headache
Upper respiratory tract infection
Less common but notable:
Hypothalamic-pituitary-adrenal (HPA) axis suppression in a small minority of subjects. This was reversible: HPA axis function returned to normal within 4 weeks of discontinuation in the cases observed.
No clinically meaningful effect on serum testosterone, DHT, or sex hormone binding globulin in the AGA Phase 3 programme, supporting the view that systemic absorption at the 5% scalp concentration is minimal.
Side effects from the Winlevi 1% acne label (which uses the same active ingredient at lower concentration on facial skin):
Skin atrophy, telangiectasia, and striae in rare cases with prolonged or excessive use.
Hyperkalaemia (raised blood potassium) was observed in a small number of patients in larger acne studies. This is consistent with clascoterone's structural similarity to spironolactone metabolites.
In female patients using clascoterone for acne, rare cases of polycystic ovary changes and menstrual irregularity have been reported.
The most important context: the safety profile of clascoterone 5% solution over 12 months of continuous twice-daily scalp use was comparable to vehicle in 1,465 men. This is a robust dataset for a new molecule. However, real-world use after approval will involve much more diverse patient populations, longer follow-up, and combination with other treatments. Some signals not seen in the trial environment may emerge. This is true of every new drug.
Who is clascoterone for, and who is it not for?
Based on the Phase 3 inclusion criteria and the mechanism of action, clascoterone is being developed specifically for:
Men aged 18 and over with mild to moderate androgenetic alopecia (typically Norwood stages II to V)
Men with healthy scalp skin and no active dermatologic conditions on the treatment area
Men with no contraindications to topical anti-androgens
Clascoterone is unlikely to be appropriate or effective for:
Men with advanced baldness (Norwood VI or VII) where follicles have already miniaturised beyond rescue. Like finasteride and minoxidil, clascoterone cannot regrow hair from dead follicles. Surgical hair transplantation is the only option once follicles are gone.
Alopecia areata (autoimmune patchy hair loss). The mechanism does not address the autoimmune attack on the follicle.
Scarring alopecias (lichen planopilaris, frontal fibrosing alopecia, central centrifugal cicatricial alopecia). These are inflammatory and require dermatologist-led treatment.
Telogen effluvium (acute stress-related shedding). This usually resolves once the trigger is addressed. Anti-androgens are not relevant.
Female pattern hair loss. The Phase 3 SCALP programme enrolled men only. Earlier small studies of clascoterone in women suggested minoxidil performed at least as well, and the regulatory pathway in women is currently undefined.
Can women use clascoterone for hair loss?
Not yet, and possibly not in the form being developed. Cosmo's Phase 3 SCALP programme enrolled men only. An earlier 61-patient study comparing 5% and 7.5% clascoterone to 2% minoxidil in women with hair loss found that minoxidil produced visible improvement in 75% of subjects, compared with 57% (5% clascoterone) and 66% (7.5% clascoterone). Minoxidil remains the first-line evidence-based topical treatment for female pattern hair loss in 2026.
For women experiencing hair thinning, the strongest currently available options in London are doctor-led PRP, topical minoxidil 2% or 5%, spironolactone (an oral anti-androgen prescribed off-label in suitable cases), investigation and correction of iron and thyroid status, and where appropriate, a hair restoration transplant referral.
Speak to a doctor about female hair loss: WhatsApp +44 7961 280835
What will clascoterone cost in the UK when it launches?
There is no published UK price for clascoterone 5% solution because it is not approved. Reasonable estimates can be made by triangulating from:
Winlevi 1% cream UK private prescription: £80 to £130 per 60g tube, lasting 30 days.
Anticipated 5% concentration twice-daily scalp dosing: approximately 90 ml per month based on the 1.5 ml twice-daily dose used in trials.
Comparable topical AGA treatments in the UK: topical finasteride from £30 to £80/month, branded minoxidil from £20 to £45/month.
Realistic ballpark for clascoterone 5% solution in the UK after launch: £100 to £200 per month, ongoing. Like all AGA treatments, the cost compounds over years because stopping the drug leads to regression.
This makes the total lifetime cost comparison interesting:
TreatmentApproximate monthly cost (UK private)10-year costGeneric oral finasteride 1mg£15 to £30£1,800 to £3,600Topical finasteride 0.25%£30 to £80£3,600 to £9,600Topical minoxidil 5%£20 to £45£2,400 to £5,400Estimated clascoterone 5%£100 to £200£12,000 to £24,000PRP maintenance (1 session every 6 months after course)£91 (averaged monthly)£10,950Hair transplant (one-off)n/a£4,000 to £15,000 (lifetime)
The economics of clascoterone will likely make it a second-line option for patients who cannot tolerate finasteride, or a combination addition rather than a standalone replacement for less expensive proven therapies.
What should I do right now, before clascoterone is approved?
This is the most actionable question for any patient reading this article. The honest answer depends on where you are in your hair loss journey.
If you are in the early stages (Norwood I to II, or noticing thinning): act now. The biggest predictor of outcome with every AGA treatment, including clascoterone when it eventually arrives, is starting before significant miniaturisation has occurred. Doctor-led assessment, treatment of any reversible drivers (iron, thyroid, hormones), and a regimen of finasteride or topical anti-androgen plus PRP or GFC is the strongest evidence-based protocol available today.
If you are in moderate stages (Norwood III to IV): there is still substantial follicular reserve to protect. PRP, GFC, or ExoRevive can reverse some miniaturisation. Adding medical therapy (oral or topical) protects the follicles you save. Waiting another two to three years for clascoterone means losing follicles that could have been preserved.
If you are in advanced stages (Norwood V to VII): medical therapy and PRP can stabilise remaining hair, but the follicles that have been lost will not return without surgical hair transplantation. We refer patients in this group to trusted hair transplant surgeons and provide PRP support before and after the procedure to maximise outcomes.
If you have tried oral finasteride and could not tolerate it: topical finasteride, topical minoxidil, and PRP are your best evidence-backed options today. Clascoterone, when approved, will be a strong addition to this regimen. There is no clinical case for an untested off-label "clascoterone" formulation in the meantime.
Start your free assessment with a GMC-registered doctor: WhatsApp us | Email: team@thewellnesslondon.com | Call: +44 20 3951 3429
Why choose The London PRP Clinic by The Wellness for your hair restoration
The London PRP Clinic by The Wellness is the only doctor-led, diagnosis-first PRP clinic in central London with two locations (Marylebone and Canary Wharf), an integrated GP service for blood-test investigation of underlying hair loss drivers, and a clinical outcome track record of 87% success and 32% average density increase across 1,200+ patients, supported by 187+ five-star verified reviews.
What sets us apart from the 60+ clinics offering PRP in London:
GMC-registered doctors perform every treatment, not nurses or aestheticians.
Advanced dual-spin centrifuge technology producing 5 to 8x platelet concentration, compared with the 1.5 to 2x concentration achieved by basic systems used in budget clinics.
Diagnosis-first protocol. Blood tests, scalp assessment, and identification of any underlying drivers before PRP is recommended. About 30% of patients we see have a reversible medical driver of hair loss.
Complete treatment ecosystem. PRP (£545/session, £1,455 for course of three), GFC (£495), ExoRevive exosome therapy (£445), combined PRP and ExoRevive (£500/session), with seamless referral to The Online GP by The Wellness for medical therapy prescribing and to trusted transplant surgeons where surgical hair restoration is the right answer.
Transparent pricing. No hidden fees. Consultation, treatment, supplements, follow-up, and photography are included in the session price.
Clascoterone-readiness. When the 5% scalp solution receives MHRA approval, our existing patients will be first in line to integrate it into their protocol. We follow the regulatory science closely and update our clinical guidance the moment new evidence is published.
Book your free hair restoration consultation in Marylebone or Canary Wharf: Message us on WhatsApp | Email:team@thewellnesslondon.com | Call: +44 20 3951 3429
Frequently asked questions
Is clascoterone safe?
The 12-month Phase 3 data published on 15 April 2026 showed a safety profile comparable to placebo in 1,465 men, with no meaningful systemic absorption at the 5% scalp concentration. Application-site irritation was the most common adverse event. A small number of trial subjects showed reversible HPA axis suppression that normalised within 4 weeks of stopping the drug. Long-term real-world safety beyond 12 months remains to be characterised.
When will clascoterone be available in the UK?
Cosmo Pharmaceuticals plans to file with the FDA in early 2027 and with the EMA in parallel. The MHRA approved the 1% Winlevi acne formulation five years after the FDA, suggesting a realistic UK approval timeline for the 5% scalp solution of 2028 at the earliest and possibly later. There is no scenario in which clascoterone is licensed for hair loss in the UK in 2026 or 2027.
Is clascoterone better than finasteride?
There is no head-to-head trial. Clascoterone showed a 168 to 539% TAHC improvement versus vehicle in Phase 3, comparable to or larger than the historical TAHC improvements reported for finasteride. Finasteride has 28 years of post-approval safety data and decades of long-term efficacy evidence. Clascoterone has 12 months of Phase 3 data. For men who tolerate finasteride well, there is no clinical reason to wait. For men who experience finasteride side effects, clascoterone is the most plausible alternative once it is approved.
Can I buy clascoterone for hair loss online?
We strongly advise against this. Any online product marketed as "clascoterone hair loss solution" is either Winlevi 1% acne cream repurposed (wrong concentration and formulation), an unregulated compounded preparation of unknown quality, or fraudulent. The 5% solution used in the SCALP trials is not commercially available anywhere in the world as of May 2026.
Can I use Winlevi for hair loss?
Winlevi 1% cream is approved for acne, not hair loss. The 1% concentration is five times lower than what was tested in the Phase 3 hair loss trials, and the cream formulation is designed for facial skin, not scalp follicle penetration. There is no published evidence of efficacy for Winlevi at 1% for hair regrowth, and we do not recommend it for that purpose.
Will clascoterone be available on the NHS?
Extremely unlikely. The NHS does not fund any medical treatment for androgenetic alopecia because it is classified as a cosmetic condition, not a clinical priority. Clascoterone will almost certainly be a private prescription product when launched, similar to topical finasteride and branded minoxidil today.
Can women use clascoterone for hair loss?
The Phase 3 SCALP programme enrolled men only. Earlier small studies in women showed minoxidil performed at least as well as clascoterone. Minoxidil 2% remains the first-line topical option for female pattern hair loss in 2026, often combined with doctor-led PRP, spironolactone, and investigation of iron and thyroid status.
How much will clascoterone cost in the UK?
There is no published UK price. A reasonable estimate based on the dosing used in trials and pricing of comparable AGA topicals is £100 to £200 per month. Like all AGA therapies, the cost compounds because stopping the drug leads to hair loss regression.
Does clascoterone work better than PRP?
They are not directly comparable. Clascoterone protects against DHT damage at the follicle receptor. PRP stimulates the follicle with concentrated growth factors. They address different parts of the same problem and are likely to be complementary rather than competing. The London PRP Clinic's documented 87% success rate and 32% average density increase across 1,200+ patients are among the strongest real-world outcomes published for any non-surgical hair loss treatment in the UK.
How do I get a hair loss assessment at The London PRP Clinic by The Wellness?
Message us on WhatsApp at +44 7961 280835, email team@thewellnesslondon.com, or call +44 20 3951 3429. Free consultations are available in our Marylebone (2 minutes from Baker Street) and Canary Wharf locations. We assess underlying drivers, build a personalised plan, and follow you through treatment with standardised clinical photography and outcome tracking.
References
Cosmo Pharmaceuticals N.V. Phase III 12-Month Data for Clascoterone 5% Topical Solution Confirm Positive Safety for Chronic Use and Continued Hair Growth. Press release, 15 April 2026.
Cosmo Pharmaceuticals N.V. Cosmo Announces Breakthrough Phase III Topline Results for Clascoterone 5% Solution in Male Androgenetic Alopecia. Press release, 3 December 2025.
SCALP 1 trial registration: NCT05910450. ClinicalTrials.gov.
SCALP 2 trial registration: NCT05914805. ClinicalTrials.gov.
Anitua E, et al. Platelet-rich plasma for androgenetic alopecia: a systematic review and meta-analysis of 43 randomised controlled trials. Dermatology and Therapy, 2025.
Trink A, et al. A randomised, double-blind, placebo and active-controlled, half-head study to evaluate the effects of platelet rich plasma on alopecia areata. British Journal of Dermatology.
MHRA. Winlevi 10mg/g cream: Summary of Product Characteristics. Updated January 2025.
British Association of Dermatologists. Androgenetic alopecia: clinical guideline. 2024 update.
Hordinsky M, et al. Phase 3 SCALP 1 and SCALP 2 trial results: clascoterone 5% topical solution for male androgenetic alopecia. Presented at clinical updates, 2025-2026.
General Medical Council. Good practice in prescribing and managing medicines and devices. Updated 2024.
Medical disclaimer
This article is for informational purposes and does not constitute medical advice. Hair loss is a clinical condition with multiple possible causes, and any treatment decision should follow assessment by a registered medical professional. The London PRP Clinic by The Wellness is operated by GMC-registered doctors at our Marylebone (W1) and Canary Wharf (E14) locations. All clinical outcome statistics referenced (87% success rate, 32% average density increase, 187+ five-star reviews) reflect real-world patient outcomes documented through standardised clinical photography and patient-reported outcome tracking. Individual results vary. Clascoterone 5% topical solution is not licensed for the treatment of hair loss in the United Kingdom or in any other jurisdiction as of May 2026.
Ready to start your hair restoration? Message us on WhatsApp | Email: team@thewellnesslondon.com | Call: +44 20 3951 3429
The London PRP Clinic by The Wellness, Marylebone and Belgavia
