Q&A: Research Leading to FDA Approval of Icotrokinra for Psoriasis, With Linda Stein Gold, MD

On March 18, the US Food and Drug Administration (FDA) approval of icotrokinra (Icotyde) for moderate to severe plaque psoriasis was announced for adults and adolescents aged 12 and older with a weight of at least 40 kg who are candidates for systemic therapy or phototherapy.1,2

The HCPLive interviewed Linda Stein Gold, MD, about icotrokinra’s recent FDA approval, the gaps this treatment fills for patients with psoriasis, and the significance of the drug’s approval as first oral targeted peptide to selectively block the interleukin (IL)-23 receptor.

The introduction of this new mechanistic class to the psoriasis armamentarium was highlighted in this interview. The following Q&A with HCPLive transcribes the interview in its entirety:

HCPLive: As one of the investigators on the ICONIC program, what did you observe that you think practicing dermatologists should know when thinking about where this drug fits relative to agents they're already comfortable prescribing?

Stein Gold: I think we've had a big unmet need for our moderate to severe plaque psoriasis patients. We have great biologic agents, we have good topical agents, but the oral space really needed something that had very good efficacy, very good safety, and very good tolerability. So I think that this drug fills that need, and where we see efficacy that's similar to biologic agents, yet we still have the good safety and tolerability. I think that this fits in nicely for any patient that needs systemic therapy.

HCPLive: What does the efficacy and safety picture tell a dermatologist who is deciding whether to reach for icotrokinra after topical failure, or to reserve it for patients who have already tried a systemic agent?

Stein Gold: When we look at the efficacy data, we see that this drug kicks in pretty rapidly. It was studied in in several phase three clinical trials against placebo, but it was also studied against deucravacitinib, prior to this drug, and this had the best efficacy for any of the oral drugs in that treatment space. What we see is the drug starts to kick in fairly rapidly.

We see a nice, deep slope, and there's good separation from the placebo, but also from deucravacitinib as early as Week Four. That continues over the 16 weeks, and we see up to about 70% of patients getting to clear or almost clear by Week Sixteen, and that continues through even the long term studies.

HCPLive: The approval includes adolescents aged 12 and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. For pediatric dermatologists who manage patients right at that threshold, how do the trial data and experience inform the potential of this agent in pediatric populations?

Stein Gold: The pediatric population who have moderate to severe psoriasis is a really important patient population. A lot of them would prefer an oral agent, and we need drugs that have been shown to be both safe and efficacious in the adolescent population. What we found was really good news. This drug actually performed even even better in the adolescence that it did in the adults, and it was equally well tolerated and a very good safety profile.

HCPLive: What did you observe in the trial around adherence and caregiver involvement among adolescent participants that practicing pediatric providers should factor into their own counseling?

Stein Gold: In the clinical trials, we asked the patients to take the medication once a day, generally in the morning after they wake up. For most people, it really fit in well with their activities of daily living. Some people take other pills, so they're used to taking a pill. For our adolescents, the idea that they didn't have to have a shot was good news for a lot of them. I think it's pretty easy, especially because it's a once daily dosing.

HCPLive: Based on what you saw in the trial population, what would you want a primary care clinician to take away about recognizing when a patient has outgrown what topicals can offer?

Stein Gold: We tend to have treatment inertia. When it comes to our psoriasis patients, [let’s say] we put them on a topical medication. Maybe they're not doing so well, so maybe we think about another topical medication. We don't always progress to a systemic medication, probably, as quickly as we need to. So, for those patients who aren't getting a really good treatment efficacy with topical medication, it's a good idea to start thinking about a systemic medication. Icotrokinra is an oral peptide. It's targeting the IL-23 receptor.

This is a key receptor in the key pathway in the pathogenesis of psoriasis, and we understand this pathway really well. We've seen with this medication, it's easy to take. You just take it once a day, usually on the in the morning, on an empty stomach. We saw efficacy start to kick in within the first several weeks, and continued improvements over the primary endpoint, which was Week Sixteen, and continued efficacy, even in the long term. I think that this fulfills an unmet need. A lot of our patients would prefer an oral option, so now we have one that really has that triad of efficacy, safety, and tolerability.

HCPLive: How would you encourage a primary care provider to re-open that conversation with a patient who previously said no to injectables and what from the trial gives you confidence that the oral route could change that dynamic?

Stein Gold: We have to remember that psoriasis is a systemic disease and that there's systemic inflammation, especially for those patients who have moderate to severe plaque psoriasis. I tell my patients that I really want to treat them as a whole. I want to get the disease under control, but I really think that they need a systemic medication. This drug allows us to offer an oral agent that targets at the key inflammatory pathway that we understand is at the root of the pathogenesis of psoriasis. It's been shown to kick in pretty rapidly, really, within the first several weeks.

It's been shown to be superior not only to the placebo, but also against oral deucravacitinib, which was the highest efficacy drug that we had prior to the approval of icotrokinra. I'm I have good confidence, especially because it was studied in adolescence down to age twelve. So, I love the fact that we have a new option for our adolescents as well as our adults who are systemic candidates.

HCPLive: Where do you hope that any additional research goes for icotrokinra and its use among such patients?

Stein Gold: I hope that we see continued research in psoriatic arthritis. I'd also love to see FDA approval for our younger patients. We know that the pediatric population psoriasis doesn't start at age twelve, and we can see it even younger. To have an oral option for our younger patients would be wonderful.

References

1. Campbell P. Icotrokinra, an Oral Il-23 Inhibitor, Receives FDA Approval for Psoriasis. HCPLive. March 18, 2026. Accessed March 20, 2026. https://www.hcplive.com/view/icotrokinra-receives-fda-approval-for-psoriasis.

2. Johnson and Johnson. FDA approves ICOTYDE (icotrokinra), the first and only targeted oral peptide IL-23 receptor antagonist, for the treatment of moderate-to-severe plaque psoriasis. Press release. Published March 18, 2026. Accessed March 20, 2026. https://www.jnj.com/media-center/press-releases.