Speaker A
In the last 40 to 50 years, the FDA has approved exactly two drugs for pattern hair loss: finasteride and minoxidil. That's the entire list.
Explore 7 promising non-approved hair loss treatments, including pyrilutamide and clascoterone, with insights on their science and timelines.
Key Takeaways
- New topical anti-androgens like pyrilutamide and clascoterone offer hope but are not yet superior to existing treatments.
- Systemic side effects are a key concern with oral DHT blockers; topical options aim to minimize these.
- Several promising treatments are in clinical trials but may take years to reach the market.
- Some widely discussed compounds lack strong clinical backing or have stalled in development.
- Precision-targeted formulations like dutasteride are currently available and may provide effective alternatives.
What the video covers
- Only two FDA-approved drugs exist for pattern hair loss: finasteride and minoxidil.
- Seven non-approved treatments are reviewed, focusing on their mechanisms and clinical progress.
- Pyrilutamide (KX-826) is a topical androgen receptor antagonist showing moderate hair regrowth in recent trials.
- Clascoterone (Breezula) is another topical anti-androgen with positive phase three results but likely less effective than finasteride.
- Precision dutasteride is a follicle-targeting formulation available now, offering an alternative to waiting for new drugs.
- PP405, a mitochondrial pyruvate carrier blocker, is highly hyped and considered a novel approach to hair loss treatment.
- JAK inhibitors are not recommended for typical pattern hair loss but may help other alopecias.
- RU58841 is a popular topical anti-androgen in forums, likely effective but weaker than dutasteride.
- Some treatments like FOL-005 have shifted focus to cosmetic use rather than drug development.
- The video also teases a bonus section on treatments frequently discussed but excluded from the main list.
Chapters
- 00:00Introduction and FDA-approved treatments overview
- 01:35Pyrilutamide (KX-826): mechanism and clinical trials
- 04:14Clascoterone (Breezula): development and efficacy
- 06:44Precision dutasteride: available follicle-targeting treatment
- 08:27PP405: innovative mitochondrial pyruvate carrier blocker
- 09:57JAK inhibitors and their limited role in pattern hair loss
- 14:47RU58841 and other topical anti-androgens in community use
- 22:58Summary and bonus treatments discussion
Full Transcript — Download SRT & Markdown
Speaker A
But we're probably closer to the next generation of hair loss treatments than most people realize. Several new treatments are already showing genuine promise, even though they haven't made it through the approval process yet. And that's what we're covering today.
Speaker A
I'm walking you through seven non-approved treatments that just might work, and exactly where the real science stands on each one. So, stick around until the end because I also have a bonus section covering a couple of treatments that come up constantly but
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didn't make the main list for very different reasons. Let's start with the two treatments that are probably going to reach patients first. Treatment number one, pyrilutamide, also known as KX-826, is a topical androgen receptor antagonist. Let me unpack that because
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it's the whole reason people are excited about it. An androgen receptor antagonist works by sitting on the receptor and blocking it. So, DHT cannot dock and shrink the follicle. It does that locally, right on your scalp, and it doesn't lower your circulating DHT
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throughout the rest of your body. That matters because DHT isn't only a hair loss villain. It does real work elsewhere in the body, including in your brain and in your sexual function. So, when you take oral finasteride or oral
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dutasteride, you're lowering DHT across the entire body. And for some men, that comes with neurological or sexual side effects. Pyrilutamide is trying to get that upside of blocking DHT at the follicle without paying that same systemic price. You're not turning your
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body's DHT down everywhere, you're just blocking the receptor in that one place that's costing you hair. So, a topical anti-androgen that leaves your systemic DHT alone is a genuinely appealing idea.
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And that's why this whole class of drugs gets so much attention in the first place. Now, I don't want to oversell it too much because blocking the androgen receptor has its own potential downsides. The androgen receptor is the
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same lock that both testosterone and DHT use. So, if enough of the drug reaches your bloodstream, you're blocking both of them at once, and that can be even more disruptive than simply lowering DHT on its own. And anecdotally, some people
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who are sensitive to finasteride also report issues with topical anti-androgens. So, a topical that completely spares you from the systemic effects is still more of a hope than a proven fact. But pyrilutamide has had a pretty rocky journey so far. The US
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phase two trial did not hit its main goal. The first China phase three in 2023 did not hit its goal, either. It wasn't until March 2026 in a new China phase three trial testing 1% and 0.5% KX-826 that they finally got a positive
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result. That trial included 666 men. The 1% dose improved hair count by about 10 and 2/3 hairs per square centimeter over placebo at 24 weeks, and the half percent dose was just a little bit behind it, a little bit under 10
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follicles per square centimeter. So, yes, that is a positive result. But at the same time, you have to be careful comparing hair counts across completely different studies. So, our view is still that pyrilutamide will not perform as well as finasteride. If it eventually
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reaches the market, I would think of it as a treatment that gives you moderate regrowth and helps slow down hair loss, but this is not a Norwood five becoming a Norwood two again. Before we go on, a couple quick caveats. Right now, it
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isn't approved as an actual drug anywhere. Kintor is pursuing approval in China after that positive phase three, and any US approval is still likely years away. Kintor, the company behind pyrilutamide, has also not fully earned our community's trust. And if you see
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pyrilutamide sold as a 0.5% solution on Amazon, that is a cosmetic drug, not the approved drug, and not the 1% version that Kintor is trying to take through approvals. The feedback so far on the Amazon products has generally been
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pretty underwhelming, so keep that in mind. You'll also hear that pyrilutamide binds the androgen receptor about 180 times stronger than clascoterone. I actually do think pyrilutamide is the stronger of the two, and the lab data, of course, backs that up,
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but I would just be careful with using that exact number as 180 times in a dish almost certainly does not translate to 180 times stronger regrowth on your scalp. So, the direction is right, but I would not take that magnitude of
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difference literally. And that brings me to the second treatment. Treatment number two, clascoterone slash Breezula. Clascoterone is already sold as Winlevi for acne, while the hair loss version is being developed under the name Breezula. It's the same molecule
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just at different concentrations and for two different conditions. Like pyrilutamide, it's a topical androgen receptor blocker. The idea is that it breaks down quickly in the skin into an inactive molecule called cortexolone, which may limit how much of the active
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drug actually reaches the rest of your body. In December 2025, the company announced positive phase three top-line results in men with mild to moderate pattern hair loss. The 12-month safety data should wrap up in 2026 with regulatory filings expected after that.
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Even if everything goes smoothly, this is still a few years away, and those timelines have moved before. That said, clascoterone is probably the closest thing we have to a new topical anti-androgen actually reaching patients. So now, what about the
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results? Here's the honest catch. The company has still not released the full absolute hair count data, only relative percentages. The best estimate we have puts the gain somewhere around 14 hairs per square centimeter, and if that holds up, clascoterone will likely
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meaningfully underperform topical 5% minoxidil and sit clearly behind finasteride and dutasteride, as well. The company likes to talk about a 539% improvement, but that's a relative number. The absolute hair count tells you much more about how a treatment
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actually performs. And by that standard, this looks like a decent option, but just not a replacement for the treatments we already have. One of the biggest reasons people are excited about clascoterone is safety. Compared to oral finasteride and oral dutasteride, it
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does appear to have a cleaner side effect profile, although I wouldn't go as far as saying none of it reaches the bloodstream. The 1% formulation showed some suppression of the body's stress hormone response, so the idea that it's
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completely systemically inert goes further than the current evidence would support. So, those are the two treatments that are closest to reaching patients. Both have shown benefits over placebo, but neither changes the standard set by the treatments we already have in terms of regrowing hair.
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But if you want something available today, rather than waiting on a phase three trial, that's why we developed precision dutasteride. It's a patent-pending follicle-targeting dutasteride formulation that's already available through Androgen. If you'd like to learn more or pick it up, you
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can do that directly through the Androgen website. The link is in the description below. Now, let's move on to the treatment that probably gets more attention than anything else on this list. Treatment number three, PP405.
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PP405 from Polage Pharmaceuticals. You've probably seen this one even if you don't follow hair loss research closely. Time named this the best invention of 2025. The company just raised $120 million in its series B.
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It's everywhere right now, and I think it's the most hyped hair loss drug probably in years. So, here's the basic idea behind PP405. It's a once-a-day topical, and the mechanism is fairly specific. PP405 blocks the mitochondrial pyruvate carrier, the doorway that
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normally feeds fuel into the cell's main energy plant. Shutting that doorway ap
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follicle stem cells towards activation. My concern with PP405 is that it may be targeting a bottleneck that isn't the primary problem in androgenetic alopecia. Here's the simplest way I'd put it. Your hair stem cells live in a part of the follicle called the bulge.
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And in pattern hair loss, the bulge stays intact. In androgenetic alopecia, the stem cell niche appears to be retained. The harder problem is downstream. The follicles struggle to turn those stem cells into progenitor cells you actually need for thick and
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healthy hair. And a big driver of that is the dermal papilla, the little control center at the base of the hair follicle, which changes its signaling and shrinks as the follicle miniaturizes. So, a drug whose whole pitch is waking up stem cells may be
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aimed at a step in the hair loss process that actually isn't the real bottleneck or driver. The human data that we have so far is still very limited. Polage's study included 78 people who used the treatment for only 4 weeks. In the men
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with a higher degree of hair loss, about 31% of those on PP405 saw their hair density increase by more than 20%, while nobody in the placebo group reached that mark. That's interesting, but it also means that most of the people in that
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study did not see that level of improvement. And honestly, the way that they're presenting this is what gives me the most pause. The standard transparent way to report a hair loss trial is target area hair count, the actual
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numbers of hairs per square centimeter people gained compared to the placebo. Instead, Polage went with this 31% of people hit more than 20% framing. And when a company reaches for a responder percentage like that instead of just telling you the average hair count, it
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usually means the straightforward number isn't as impressive as they'd like. Now, I want to be fair here. The science is genuinely interesting and somewhat new.
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And if the phase three trial eventually proves me wrong, I'll come back on here and say so on camera. In my view, $100 million and a magazine award are not the proof of efficacy that I'm looking for.
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That's my opinion, not a claim about the data itself, which still just shows a four-week trial in 78 people. So, if that one surprised you, the next one is almost the mirror image of it and appears to have stalled out. Treatment
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number four, SM04554, came from a company called Samumed, which later rebranded as Biosplice. The idea behind this treatment was very different than PP405. Instead of changing how cells produce energy, SM04554 tried to modulate Wnt signaling, a pathway involved in hair follicle
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development, regeneration, and the hair growth cycle more broadly. There was a lot of excitement around Samumed at one point. The company raised huge amounts of money and was valued at around $12 billion, although some observers were skeptical about the broader regeneration
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claims being made. The early studies showed a modest but mixed signal. The 0.15% looked better than the vehicle in their phase two, but the higher 0.25% dose did not produce a clean, stronger response. That does not automatically mean that the treatment does not work.
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Clinical trials can be messy, and biology is not always linear. But when the lower dose looks better than the higher dose, researchers usually pay close attention because it raises questions about the mechanism, the formulation, or the reliability of the
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signal. The bigger issue is what happened next. A phase three trial finished years ago, but the results were never meaningfully published or promoted. Of course, we do not know exactly what happened behind the scenes, but when a large clinical trial produces
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strong results, companies usually want people to know about it. So, at this point, I do not see much reason to be excited about SM04554.
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The story was huge a few years ago, but there is very little motion today to suggest that it is moving forward. That brings us to the fifth treatment, JAK inhibitors. JAK inhibitors, including topical ones like ruxolitinib, confuse a
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lot of people, so let me explain it simply. JAK inhibitors reduce inflammatory immune signaling that matters in alopecia areata, where the immune system attacks the hair follicles and causes patchy hair loss. When you calm that immune attack, the hair can
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then grow back. Pattern hair loss is different. It is not primarily an autoimmune disease, it is mainly driven by androgen-sensitive follicle miniaturization over time, especially through DHT signaling in susceptible follicles. So, there is not the same obvious immune target for the JAK
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inhibitor to hit. That is why the FDA-approved JAK inhibitors for hair loss today are for severe alopecia areata, not androgenetic alopecia.
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Baricitinib was approved in 2022, ritlecitinib in 2023, deuruxolitinib in 2024, but all three are oral drugs for severe alopecia areata. We still do not have an FDA-approved JAK treatment for androgenetic alopecia, and the human data for pattern hair loss is extremely
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limited. The oral versions also come with serious warnings, including infections, blood clots, cardiovascular events, and malignancies. Even topical ruxolitinib, sold as Opzelura, carries a class warning, though systemic exposure is generally expected to be lower than with oral JAK inhibitors. Opzelura
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itself is approved for conditions like eczema and vitiligo, not pattern hair loss. Some doctors and patients may experiment with topical JAK inhibitors off-label for hair loss, but the published evidence is mostly in alopecia areata or inflammatory and scarring
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alopecias, not typically male or female pattern hair loss. So, if you're dealing with typical pattern hair loss, I do not think JAK inhibitors are where you should be directing your attention. Now, the next treatment is the one that many
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of you are most emotionally invested in, and that is hair cloning. The idea behind hair cloning sounds incredible.
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Take a few healthy hair follicles, grow more of those cells in a lab, and create an unlimited supply of new hair to transplant. No donor hair limits, no running out of grafts. The problem is that people have been saying this is 5
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to 10 years away for more than 20 years. And the biggest challenge is actually pretty simple. When researchers take dermal papilla cells out of a follicle and grow them in a lab, they tend to lose their ability to create new hair
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follicles. Getting around that, and then assembling everything into a working hair follicle that you can implant at scale has been the real sticking point.
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And that's why we still don't have a commercial treatment. A lot of the companies people were excited about have also struggled in recent years. Stemson Therapeutics, a favorite of mine, shut down in December 2024 after running out of funding. They never reached human
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trials, and their best results were still only in mice. Follica is another example. Around 2020, it looked like it was getting close to a late-stage product, but the program was put on hold a few years later by its parent company.
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A lot of companies still talk about human trials happening in 2025 or 2026, but as we know, that's no longer the case. That doesn't mean the science behind it is impossible. It simply means turning that science into a real
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treatment has been much harder than many people expected. Then there's Suji's group in Japan, and this is one I take most seriously. We actually sat down with Suji for a full interview. It's right here on this channel. And out of
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everyone working on hair cloning, this is the project with the best chance of working. The goal is limitless hair transplants, which could give you hair for life. And they've talked about starting human trials somewhere between 2027 and 2029. And this group does have
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momentum, which is rare in this space. They've kept publishing their research, they've drawn real attention from major media in Japan, and they're working to move their regenerative approach out of the lab and towards the clinic rather than stalling out in the way that so
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many of these other companies have. I still want to be straight with you about those dates. Human trials haven't started yet, and timelines in this field have a long history of slipping. So, hold the years loosely. But, if any
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group on Earth pulls off hair cloning, this is probably going to be the one I'd bet on. Now, the next treatment also targets the androgen receptor, but instead of just blocking it, it removes it from the equation entirely. GT20029
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from Kintor, the same company that is bringing us pure lutamide. So, Kintor is taking two different shots at the same target. Pure lutamide sits on the androgen receptor and blocks it, the same basic idea as clascoterone. further and tags that receptor
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for destruction entirely. It's called a protec, a protein degrader, and it's a different category of drug than anything else on this list. A phase two study from China published in 2025 included 180 men and showed an improvement of
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about 6.7 hairs per square centimeter over placebo after 12 weeks. That's a decent signal, but it is still very early. The US program has only completed early safety testing, and phase three is still ahead of us. I think it's an
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interesting area of research, but right now we just don't have enough clinical data to know how useful this would actually be in the real world. So, I really wouldn't make any treatment decisions around it today. But, it's definitely something to keep an eye on
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over the next couple of years. So, where does all of this leave us? Pure lutamide and clascoterone are the two closest treatments to reaching more patients, but neither has shown the results beat minoxidil, finasteride, or dutasteride.
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CB-01-05 has generated a lot of excitement, but I'm still not convinced that it's targeting the main problem in pattern hair loss. SM04554 looked promising for a while, but we haven't seen any meaningful progress in years. JAK inhibitors work well for
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alopecia areata, but that's a completely different condition from androgenetic alopecia or male and female pattern hair loss. Hair cloning is still being worked on, but we're much further away from a real treatment than many people realize.
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AndroGene 20029 is interesting, but it's still very early with a lot of clinical testing ahead. Now, let's get to the bonus section. I want to spend most of it on the one treatment that comes up in our community more than almost anything
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else. RU58841. If you spent any time in hair loss forums, you've definitely seen this one.
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RU58841 is a topical androgen receptor antagonist, the same basic class as pure lutamide and clascoterone. It sits on the receptor and blocks both DHT and testosterone right there on the scalp.
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The most interesting part is the backstory. RU58841 goes way back. It was developed under the name PSK3841 by a company called Prostratin, which is now part of Kyowa Kirin. It appears [clears throat] to have been shelved for business or development reasons rather
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than because of a clearly published efficacy trial. So, it did reach human trials, but it never completed the normal development path, and the full human results were never published in the way you would expect for a serious drug program. We have references to
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clinical evaluation in phase two development, but we were not ever showed a proper peer-reviewed phase two paper with clear hair count data, adverse events, pharmacokinetics, and long-term follow-up. What we do have publicly is mostly older animal work and human skin
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grafts work, which looked encouraging. In those studies, RU58841 showed local anti-androgen activity on the scalp with limited evidence of systemic hormonal effects. On paper, the systemic exposure from a normal topical dose should be relatively low, but without the full human data, that is
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still not something that I would treat as proven. That mix of a plausible local effect, probably limited systemic absorption, and a drug that's been abandoned and largely forgotten by the industry for decades is exactly why RU58841 has the cult following that it
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does. A lot of people in our own community use it and report real results. Some of them are dramatic. Our honest read is that it probably does work as a topical anti-androgen, though it's likely weaker than dutasteride, and
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there are now newer, better studied receptor blockers like pyrilutamide actually going through trials for us to focus on. Here's the real issue, and it's a big one. RU58841 probably works, but it's never actually become an approved drug. Nobody is
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running the long-term human safety trials it would need. And like any androgen receptor blocker, it can block both DHT and testosterone, so without solid long-term data, nobody can really tell you what years of daily use does to the rest of your body. We even looked at
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this ourselves, and at one point we tried to buy the old RU58841 trial data from ProStrakan's successor, Kyowa Kirin, so the drug could be developed the right way, and unfortunately, they said no. For what it's worth, they may have actually lost
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the data. So for now, the only way to get RU58841 is a research chemical that people order online and mix themselves, with no regulator checking what is actually in the vial and no quality control.
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Personally, I don't think that's the position people should put themselves in, especially when we already have treatments with far stronger clinical evidence behind them. The other non-approved drug worth a quick mention is FOL-005 from a company called Follicum. The idea
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was genuinely clever. It was a peptide derived from a protein called osteopontin, but when they ran the topical phase 2A trial, it missed its primary endpoint. The treatment group, unfortunately, barely separated from the placebo. Follicum was later absorbed by
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another company, and since then the conversation around it has been primarily about cosmetic use rather than a real drug. So, at this point there really isn't much reason to count on FOL-005.
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If there's one thing I want you to take away from this video, it is this. Every number you hear today needs to be judged against the treatments we already have.
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If a press release says a new drug grows 10 hairs per square centimeter, that can sound impressive until you put it next to plain old minoxidil. In its own trials, 5% minoxidil grew roughly 15 hairs per square centimeter more than
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the placebo and over 20 from baseline. So, a lot of these newer drugs don't actually match minoxidil. They come in under it and in some cases by a wide margin. But, here's the more useful way to think about them. Several of the most
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clinically advanced new drugs work on the androgen receptor, which is a completely different pathway from how minoxidil works. So, the smartest way to use them, if they ever reach the market, is probably alongside minoxidil rather than instead of it, where two different
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mechanisms could stack and add up. Now, oral minoxidil has its own trade-offs. It was designed as a cardiovascular drug, and some of its acute side effects may be related to how quickly and how high it peaks in the bloodstream. And
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that's exactly why we developed our own lipid matrix modified release formulation called Minoxidil. Uh, we spent a considerable amount of time testing how changing the release profile affects what actually happens in human blood. The data we found in human blood
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was surprising enough that I think it deserves its own conversation. So, if you're considering minoxidil and want to understand how minx works and what we actually measured, watch the next video.
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Topics:hair losspattern hair lossfinasterideminoxidilpyrilutamideclascoteronetopical anti-androgensPP405JAK inhibitorsRU58841
