Q&A: 1-Year Efficacy Data on Clascoterone 5% in Androgenetic Alopecia, With Maria Hordinsky, MD

In April, Cosmo Pharmaceuticals released new, positive 12-month phase 3 findings on clascoterone 5% topical solution in male patients living with mild-to-moderate androgenetic alopecia (AGA), with sustained efficacy being observed with continued use in the program.1,2

The study, involving 1465 patients across 51 sites in the US and Europe, was the largest phase 3 clinical analysis effort to date for a topical drug in male patients with AGA. In light of the lack of newly-approved drugs for AGA in more than 3 decades, HCPLive spoke in an interview with Maria Hordinsky, MD, an R.W. Goltz Professor of Dermatology at the University of Minnesota and a lead investigator in the trial program, who spoke about the clinical and patient-centered implications of these data.

The following Q&A transcript summarizes Hordinsky’s responses to HCPLive’s inquiries about the new data on clascoterone 5% topical solution for patients with hair loss in the form of AGA:

HCPLive: What were the most important takeaways from this phase 3 study of clascoterone 5% topical solution for patients with androgenetic alopecia (AGA)?

Hordinsky: I'll think about this from the perspective of a patient in the clinic, and think about what patients are looking for. There hasn't been a new FDA treatment, a medical treatment, for over 30 years. It's been a long time since something has come to this point with the current medication. So, we now have the opportunity to really use a topical agent that targets the androgen receptor, one of the key players in androgenetic alopecia. Patients in this particular study, phase 2 and phase 3, have done very, very well. It looks like we're going to very soon have a new tool in our toolbox that will be able to offer male patients with androgenetic alopecia. It's actually very exciting.

HCPLive: We also wanted to go explore some of the findings. The data show continued hair growth from Month 6 to Month 12. How clinically meaningful is that sustained response for patients?

Hordinsky: That is very clinically relevant. What I would love to see…but again, the FDA did not require this. I think it'd be great, and we'll get it in real-world data, [but I’d love us] to be able to see the durability over years of use. But the fact that the durability was there at the 12-month mark and also was showing, at that time, continued improvement is, again, something very exciting.

HCPLive: Can you explain the significance of the 239% relative improvement in target area hair count and how that translates into real-world outcomes?

Hordinsky: Patients with pattern hair loss, if you talk to them about hair counts in a circle, it probably doesn't mean very much to people. You might have X number of fibers, and then you double it or triple it, and then you'll see something there. But from the patient's perspective, they're looking at the global picture, the big picture. So, the patient's perspective is really, really important. Then, when you go to that target area, you see this increase in hair counts to this particular significant number. That is really important, because that is visible and it's real.

HCPLive: What does the comparison between patients who stayed on treatment versus those who switched to vehicle tell us about the importance of continuous therapy?

Hordinsky: I think all these studies were done very well. I think it's always important to have a group of people who are treated, and then at some point in time, in a randomized manner, are switched to the placebo group, because you can see the improvement, and then you can see the decline. I think, like with most hair conditions when we treat [them], the decline is not like jumping off a cliff. It's gradual. So, in all likelihood, down the road and in the future, one will actually be able to capture that, because people sometimes get sick. You know, things happen in life. You're going to come off the medication for a bit of period of time, and I think people just have to recognize from this data that, yes, you might go backwards a little bit, but you can probably catch up.

HCPLive: Based on these findings, how do you see clascoterone solution fitting into the current treatment landscape for hair loss?

Hordinsky: Well, I think hair is hot right now in so many ways. There are so many things that are being looked at from so many different perspectives for the treatment of pattern, hair loss, this particular product, product, and tool is here at the right time, because many of the other tools are still very early in development. From a patient's perspective, there are those who just want to do something topically. They don't want to take a pill. They want something very conservative. And then some want to do everything possible and add PRP and everything to the mix of what they're doing. It will be a great tool to use for people who have pattern hair loss, who are either very conservative or want to do everything that they can.

But the other place where this really fits is that the vehicle and the delivery system are very, very nice. It's easy to use and it's something that, if you think about your 18-year-old male who's going to college, sometimes that type of person wants to take a pill by mouth, but at other times, the person, again, just wants something straightforward and simple. This is going to be something that will fit the lifestyle of that particular person. It will also be a tool for many patients who really do not want to be taking any type of anti-androgen or medication currently on the market that can affect libido or sex drive, because right now, we know with this medicine, even though it is an androgen blocking agent, a receptor blocking agent, no such side effects were detected in the clinical trials. I think that's really important.

The quotes used in the above summary were edited for the purposes of clarity.

Hordinsky has served on an advisory board for AbbVie (fees) and as an investigator receiving grants or research funding from Arcutis Biotherapeutics, Cassiopea, Concert Pharmaceuticals, Eli Lilly and Company, National Alopecia Areata Foundation, RegenLab, and Sun Pharmaceuticals. She has also received fees for other work with UpToDate, Inc.

References

1. Phase III 12-Month Data for Clascoterone 5% Topical Solution Confirm Positive Safety for Chronic Use and Continued Hair Growth, both of which Are Statistically Significant. Cosmo Pharmaceuticals. April 15, 2026. Accessed April 30, 2026. https://www.cosmohealthconfidence.com/news/98958067-clascoterone-12-month-safety-results-ende.

2. Hordinsky M. Phase 3 SCALP Study on Clascoterone for Androgenetic Alopecia, With Maria Hordinsky, MD. HCPLive. December 18, 2025. Accessed April 30, 2026. https://www.hcplive.com/view/phase-3-scalp-study-clascoterone-androgenetic-alopecia-maria-hordinsky-md.