Raj Chovatiya, MD, PhD

Takeda has reported site-specific responses among patients with 

 in the scalp, nails, palms and soles with zasocitinib, an investigational once-daily oral tyrosine kinase 2 (TYK2) inhibitor, in 2 phase 3 trials.¹

LATITUDE PsO 3001 and 3002 enrolled 693 and 1,108 adults with moderate-to-severe plaque psoriasis and compared zasocitinib with placebo and apremilast.¹ The 

 has accepted the New Drug Application under Priority Review, with a target action date slated for the first quarter of 2027, Takeda announced in September 2026.¹

At Week 16, 77% of those in 3001 and 74% in 3002 attained scalp-specific Physician Global Assessment (ssPGA) scores of 0 or 1, compared with 7% and 13% with placebo (

 < .001).¹˒² The Nail Psoriasis Severity Index (NAPSI) least-squares mean shift from the point of baseline was -7.1 in 3001 and -8.6 in 3002 (

 < .001 vs placebo).¹˒² Hands and/or feet Physician Global Assessment (hfPGA) scores of 0 or 1 occurred in 71% and 69% with zasocitinib, compared with 22% and 10% with placebo, in a secondary endpoint not controlled for multiplicity.¹

In 3002, 17% of patients reached Psoriasis Area and Severity Index 75 (PASI 75) at week 4 with zasocitinib, compared with 4% with placebo (

 < .001).¹ Takeda also reported skin clearance increasing through weeks 24 and 52, with no new safety signals.¹ The open-label LATITUDE PsO 3003 study, which enrolled about 2,100 participants, is evaluating long-term safety, tolerability and efficacy.¹

Raj Chovatiya, MD, PhD, a board-certified dermatologist and associate professor at Rosalind Franklin University Chicago Medical School, also founded and directs the Center for Medical Dermatology + Immunology Research in Chicago. In the following Q&A interview discussion, Chovatiya shares his perspective on special site involvement, speed of response and once-daily dosing with zasocitinib:

HCPLive: Why are the scalp, nails, palms and soles particularly challenging areas from both a treatment and cosmetic perspective?

 In psoriasis, we talk about special sites, and what really makes them special is, number one, they seem to potentially be slightly more difficult in terms of drug penetration. So we've always wondered if you had the right type of targeting agent, could you potentially hit better efficacy? And two, individuals who may have involvement of these areas can have relatively limited extent, but they oftentimes feel the same degree of burden as somebody who might have more traditional plaque psoriasis from head to toe.

If you think about your scalp being a part of the head and neck region that you have to go about every single day, talking to folks, having people looking at you, when you think about your hands, shaking hands, going out there doing your work and day-to-day functioning, thinking about your nails, even thinking about the genital region as well, all of these are special in the sense that they're often associated with undue burden for our patients. So it's particularly exciting, beyond some of the top-line data we've seen, that zasocitinib can result in a high degree of clearance in these areas too. And I think the scientific question that's very interesting is, now with more and more small-molecule options coming about in psoriasis, might there be a pathogenic reason why we see efficacy there compared to biologic therapies?

That question isn't really known, but we wonder if there's going to be a root reason why we could potentially have better effect there, or even a target standpoint. One of the theoretical ideas with TYK2 inhibition has been, given its role in other elements of the immune system signaling pathway, could it potentially result in some different degrees of clearance in some of these sites too? And I think that's really what the next generation of research is setting us up for, as long as we have newer therapeutic options.

: With about 70% of patients achieving clear or almost clear skin at week 16, how quickly might patients see a visible difference?

 One of the nice things about the data cuts we've seen from zasocitinib so far is that it definitely doesn't appear to be slow. I think our patients are going to start seeing meaningful differences pretty early, and it seems like many of these results also continue to improve, potentially even beyond the primary period of our examination as we enter longer phases of this study. Compared to the way we've felt about oral therapies prior, and particularly in the case of our more first-generation TYK2 inhibitors, I think we're going to be able to have a reasonable discussion and balance of speed, effectiveness, as well as long-term effectiveness and durability overall.

: How might a once-daily oral option like zasocitinib change the conversation around managing visible psoriasis?

I think if somebody can get over the idea of having to use something beyond a cream, then a once-daily option you can take orally resonates with the way we've all thought about medications all of our lives. Whether you think about antibiotics or analgesics or cold medication, they're all essentially once-daily medications that you take for varying degrees of time. In this case, this one would be more of a chronic medication. But I think the idea of something you just have to take once a day as a pill continues to be an important piece in the psyche of just human beings when thinking about medications overall.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.

Takeda Pharmaceutical Company Limited. U.S. FDA accepts new drug application under priority review for Takeda's zasocitinib in moderate-to-severe plaque psoriasis, with potential to redefine oral treatment expectations. Published September 14, 2026. Accessed September 21, 2026. 

https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/

Armstrong AW, et al. Zasocitinib, a once-daily oral TYK2 inhibitor, demonstrates efficacy at high impact sites in adults with moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002). Presented at: 2026 American Academy of Dermatology Innovation Academy; July 16, 2026; New York, NY.

Articles

Takeda’s investigational once-daily oral TYK2 inhibitor zasocitinib demonstrated robust special-site efficacy in phase 3 plaque psoriasis, with high rates of scalp clearance and meaningful improvements in nail disease, plus strong hands/feet responses. Onset appeared rapid, with early PASI 75 separation by week 4 and continued gains through weeks 24 and 52, without new safety signals. FDA accepted the NDA under Priority Review with an action date anticipated in Q1 2027. Long-term safety and durability are being assessed in a large open-label extension.

Raj Chovatiya, MD, PhD, on zasocitinib results in the scalp, nails, palms and soles, speed of response and once-daily oral dosing in psoriasis.

Q&A: Zasocitinib Response in the Scalp, Nails, Palms and Soles

 accepted a New Drug Application for zasocitinib (TAK-279), an investigational once-daily oral tyrosine kinase 2 (TYK2) inhibitor, for adult patients with moderate-to-severe plaque psoriasis, Takeda announced on September 14, 2026.¹ The application received Priority Review, with a Prescription Drug User Fee Act target action date in the first quarter of 2027.¹ Additionally, the European Medicines Agency accepted a marketing authorization application.¹

The filing followed the phase 3 LATITUDE PsO 3001 and 3002 analyses, which enrolled 693 and 1108 adults across 21 countries and compared zasocitinib with placebo and apremilast.¹ At Week 16, 71% of patients in 3001 and 69% in 3002 reached a static Physician Global Assessment (sPGA) score of 0 or 1 with zasocitinib (

 < .001 vs placebo).¹˒² Response rates were 32% and 30% with apremilast and 11% and 13% with placebo.¹˒²

Psoriasis Area and Severity Index (PASI) 75 rates were 76% in 3001 and 71% in 3002 with zasocitinib, compared with 37% and 33% with apremilast and 12% with placebo in both trials.¹˒² PASI 90 rates were 61% and 52% with zasocitinib, 17% and 16% with apremilast, and 5% and 4% with placebo.¹˒²

Takeda reported no new safety signals, with upper respiratory tract infection (10.1%), acne (6.5%) and nasopharyngitis (6.2%) as the most common adverse events across the 2 trials.¹ Raj Chovatiya, MD, PhD, is an associate professor at Rosalind Franklin University Chicago Medical School and founder and director of the Center for Medical Dermatology + Immunology Research in Chicago. During this Q&A interview, Chovatiya discussed where zasocitinib may fit in the psoriasis treatment algorithm and what high clearance rates could mean for patients":

: Where do you see zasocitinib fitting into the psoriasis treatment algorithm relative to biologics and other oral options like apremilast?

It's an exciting announcement, perhaps one we should have been expecting based on the data we've seen. Your question about whether we need more in psoriasis is a good one, because we have more than a dozen options, obviously a number of biologics. Orals have now started to creep into the landscape beyond even apremilast. We had deucravacitinib a few years ago, which had its own hits and misses, and of course, most recently, icotrokinra as well. When thinking about where treatment options fit, we still continue to struggle with making sure all of our patients with moderate to severe psoriasis are on an appropriate, targeted, advanced therapeutic.

So point number 1, whether it's an injectable or an oral, is that getting somebody to the next step of treatment beyond topicals is key. That is one great place where you're going to see a medication like zasocitinib fit. 2, the debate about oral versus biologic has long slanted toward biologics if it's purely based on efficacy. Now, as we're starting to see newer biologic therapies, both small peptides and next-generation TYK2 inhibitors, there's at least more of a comparative similarity between them in terms of how many patients can get relatively clear. So at least you can offer somebody a different route or option if that's what fits in with their life.

And 3, orals have a certain innate sense in a lot of folks that these medications are very similar to something I've used before. If I'm particularly naive to taking systemic medications for most conditions, this might be a way for me to dip my toe in. So what we hope is that medications like zasocitinib may make more individuals who are just entering the systemic-ready phase, or who have more limited areas that are really burdensome, ready to take a therapy.

: How meaningful could high rates of clear or almost clear skin with zasocitinib be from an aesthetic and quality-of-life perspective?

 Immense. If patients were on the fence before, and a lot of it came down to the idea of having to use a biologic therapy, then the idea of an oral treatment that can offer patients a chance to essentially clear up their skin, get their life back, go about their day-to-day function, and perhaps believe they can be their best aesthetic and cosmetic self, that potential difference you can make in a patient's life is huge. So I think a medication like zasocitinib, with some of those high clearance rates, really speaks to what could be possible and the large gap that still remains in terms of our untreated patient population.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Chovatiya previously reported serving as an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Formation Bio, Galderma, Genentech, GSK, Incyte, LEO Pharma, L’Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer Inc., Regeneron, RAPT, Sanofi, Sitryx, and UCB.

Gooderham M, et al. Once-daily oral zasocitinib demonstrates rapid and reproducible skin clearance with a consistent safety profile in moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002). Presented at: 2026 American Academy of Dermatology Innovation Academy; July 16, 2026; New York, NY.

FDA accepted and granted Priority Review to the NDA for zasocitinib (TAK-279), a once-daily oral TYK2 inhibitor, for adults with moderate-to-severe plaque psoriasis, with a PDUFA target in Q1 2027; EMA also accepted the MAA. In phase 3 LATITUDE-PsO 3001/3002 (n=693/1108), zasocitinib significantly outperformed placebo and apremilast on sPGA 0/1 and PASI 75/90 at Week 16. No new safety signals emerged; URTI, acne, and nasopharyngitis were most common.

In this Q&A, Raj Chovatiya, MD, PhD, discusses where zasocitinib fits in the psoriasis treatment algorithm and what high clearance rates mean for patients.

Q&A: Zasocitinib's Role Beyond Topicals in Moderate to Severe Psoriasis

Chovatiya said scalp, nail, and hand psoriasis can carry heavy burden even when disease extent is limited.

He said zasocitinib does not appear slow to act, with responses that may keep improving over time.

He said a once-daily pill may help patients move beyond topical therapy.

Zasocitinib, an investigational oral tyrosine kinase 2 (TYK2) inhibitor under 

US Food and Drug Administration (FDA) priority review

 for moderate to severe plaque psoriasis, produced high levels of skin clearance in hard-to-treat and high-impact regions of the body in phase 3 trials.¹˒²

Raj Chovatiya, MD, PhD, clinical associate professor of medicine at Rosalind Franklin University Chicago Medical School and founder and director of the Center for Medical Dermatology and Immunology Research in Chicago, Illinois, spoke with the 

What Zasocitinib Data Mean for Scalp, Nail, and Hand Psoriasis

Why Are Special Sites Like the Scalp, Nails, and Hands Hard to Treat in Psoriasis?

Chovatiya said special sites are challenging for 2 reasons. Drug penetration may be somewhat harder in these areas, raising hope that the right targeted agent could deliver better efficacy. Individuals with involvement in such areas may also have limited disease extent despite feeling a burden comparable to individuals who have reported having head-to-toe plaque psoriasis.

He pointed to the scalp as part of the head and neck region that patients present to others each day, and to the hands used for handshakes and work. Nails and the genital region also carry undue burden, he noted. At week 16, scalp-specific Physician Global Assessment (PGA) scores of 0 or 1 reached 77% and 74% with zasocitinib in the 2 trials, and 71% and 69% of patients evaluated for palmoplantar involvement reached a hands and/or feet PGA of 0 or 1.¹

Chovatiya also highlighted an open scientific question: whether a pathogenic or target-related reason, such as the role of TYK2 in other immune signaling pathways, might help explain the differing clearance rates observed at these sites compared with biologics. The answer is not yet known, he noted.

How Quickly Could Patients See Visible Skin Changes With Zasocitinib?

About 70% of patients in the pair of phase 3 trials achieved clear or almost clear skin by week 16.¹ Chovatiya said data so far suggest that zasocitinib is not slow to act, and he expects patients to notice meaningful differences early. Responses also continue to improve beyond the primary period, he added, and Takeda reported clearance as early as week 4, rising through week 52.¹

Compared with earlier oral therapies, particularly first-generation TYK2 inhibitors, Chovatiya noted that with zasocitinib, clinicians may be able to discuss a balance of speed, effectiveness, and durability.

How Could a Once-Daily Oral Option Change the Conversation About Visible Psoriasis?

For patients willing to move beyond a cream, Chovatiya said a once-daily pill resonates with how people have long thought about medications, such as antibiotics, analgesics, and cold remedies. Zasocitinib would be a chronic medication, he noted, but a daily pill remains an important part of how people view treatment.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Chovatiya previously reported serving as an adviser, consultant, speaker, and/or investigator for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Formation Bio, Galderma, Genentech, GSK, Incyte, LEO Pharma, L’Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer Inc., Regeneron, RAPT, Sanofi, Sitryx, and UCB.

US FDA accepts new drug application under priority review for Takeda's zasocitinib in moderate-to-severe plaque psoriasis. News release. Takeda. September 14, 2026. Accessed September 18, 2026. 

Smith T. FDA priority review granted to zasocitinib for moderate to severe psoriasis. HCPLive. September 14, 2026. Accessed September 18, 2026. 

https://www.hcplive.com/view/fda-priority-review-granted-zasocitinib-moderate-severe-psoriasis

Videos

Raj Chovatiya, MD, PhD, discusses how the oral TYK2 inhibitor zasocitinib may affect scalp, nail, and hand psoriasis, clearance speed, and once-daily dosing.

The FDA accepted the zasocitinib NDA under priority review, with a decision expected in the first quarter of 2027.

Chovatiya said newer oral agents are narrowing the efficacy gap with biologics, giving patients another route to advanced therapy.

He said high clearance rates could ease hesitancy toward biologics and improve quality of life.

 has accepted Takeda's new drug application for zasocitinib, an investigational oral tyrosine kinase 2 (TYK2) inhibitor, under priority review for adults with moderate to severe 

.¹˒² A decision is expected in the first quarter of 2027.¹

Raj Chovatiya, MD, PhD, clinical associate professor of medicine at Rosalind Franklin University Chicago Medical School and founder and director of the Center for Medical Dermatology + Immunology Research in Chicago, Illinois, spoke with 

 about how the agent could fit into a crowded treatment landscape.

Zasocitinib NDA Acceptance: What It Means for Psoriasis Treatment

The filing rests on the phase 3 LATITUDE PsO 3001 (NCT06088043) and 3002 (NCT06108544) trials. A static Physician Global Assessment (sPGA) score of 0 or 1 at Week 16 was reached by 71% and 69% of zasocitinib-treated patients, versus 11% and 13% on placebo and 32% and 30% on apremilast (Otezla) (

Where Does Zasocitinib Fit in the Psoriasis Treatment Algorithm?

Chovatiya noted psoriasis already has more than a dozen treatment options, including many biologics and oral agents such as apremilast, deucravacitinib (Sotyktu), and icotrokinra. He said the first priority remains moving every patient with moderate to severe disease beyond topical therapy to a targeted advanced treatment, whether injectable or oral.

The oral-versus-biologic debate has long favored biologics on efficacy alone, according to Chovatiya. Newer agents, including next-generation TYK2 inhibitors and small peptides, are narrowing the gap in the proportion of patients reaching relatively clear skin. Clinicians can offer a different route based on patient preference.

Could an Oral TYK2 Inhibitor Bring More Patients to Systemic Therapy?

Chovatiya said oral medications feel familiar to many patients, which may lower the barrier for those naive to systemic therapy. He suggested zasocitinib could draw in patients entering the systemic-ready phase, along with those with limited but particularly burdensome disease areas. Scalp-specific PGA scores of 0 or 1 reached 77% and 74% with zasocitinib across the two trials.¹

Zasocitinib was generally well tolerated, and Takeda reported no new safety signals. Adverse events in at least 5% of patients included upper respiratory tract infection (10.1%), nasopharyngitis (6.2%), and acne (6.5%).¹

How Might Skin Clearance With Zasocitinib Affect Quality of Life?

Chovatiya described the potential quality-of-life effect of high clearance rates as substantial. Patients hesitant about biologics could gain a chance to clear their skin, resume daily function, and feel more confident about their appearance. He added the clearance rates show what may be possible, given the large gap among untreated patients.

Takeda. U.S. FDA accepts new drug application under priority review for Takeda's zasocitinib in moderate-to-severe plaque psoriasis. News release. September 14, 2026. Accessed September 18, 2026. 

Raj Chovatiya, MD, PhD, explains where oral TYK2 inhibitor zasocitinib may fit in psoriasis treatment after the FDA accepted its NDA under priority review.