New Psoriasis Medications: 11 Drugs Seeking FDA Approval

Your skin contributes to your appearance — color, wrinkles, freckles, and all. But it also supports your health. It protects you from germs and keeps your body at a stable temperature. That’s why protecting your skin is so important.

Yet, even with the best skin care routine, it’s hard to have perfect skin. Many things are out of your control. Inflammatory health conditions, such as psoriasis, can arise and disrupt your life. It can take many trips to the dermatologist and trying various moisturizers and medications before finding a treatment plan that works for you.

And that’s because there are quite a few options to choose from. Researchers have been developing and improving psoriasis medications for decades. The FDA has approved dozens of new psoriasis medications since the turn of the century alone — with a big focus on biologic medications. Health experts are expecting to see even more approved in the coming months and years.

Here, we’ll highlight 11 new psoriasis medications in advanced stages of clinical trials. This isn’t an exhaustive list.

1. Picankibart

Picankibart (IBI112) is a monoclonal antibody in development for plaque psoriasis. This under-the-skin injection interferes with an inflammatory protein called interleukin-23 (IL-23). This is comparable to psoriasis medications like Skyrizi (risankizumab) and Tremfya (guselkumab).

Blocking IL-23 appears to be an effective treatment strategy for many people. Up to 86% of people receiving the medication in a phase 2 study achieved at least 90% symptom improvement after 1 year of treatment. More recent phase 3 study data also demonstrated positive results.

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The company that makes picankibart is actively seeking approval in China. An FDA approval application may come next..

2. Icotrokinra

Icotrokinra (JNJ-2113) is an oral pill being studied for moderate-to-severe plaque psoriasis. Unlike many other potential psoriasis medications, which are injectable biologics, icotrokinra is a small-molecule oral peptide that blocks IL-23.

In a recent phase 3 clinical trial, icotrokinra helped nearly 75% of people achieve clear or almost clear skin after 24 weeks (about 6 months). Side effects were similar between people who received icotrokinra or placebo, suggesting the medication is both effective and well-tolerated for treating psoriasis.

Other phase 3 trials are now in process. They’re scheduled to run through 2027. If results remain positive, icotrokinra could become the first oral IL-23 inhibitor approved for psoriasis.

3. Ebdarokimab

Ebdarokimab (AK 101) is a monoclonal antibody medication that treats plaque psoriasis by targeting two inflammatory proteins, interleukin 12 (IL-12) and IL-23. This is similar to how Stelara (ustekinumab) works. It's given as a once-monthly, under-the-skin injection.

A phase 3 study found that people who received ebdarokimab for psoriasis saw significant improvement in their skin symptoms. After 1 year, around 80% of people who received the medication achieved at least a 75% reduction in psoriasis severity.

This treatment is now in advanced stages of development. It has already finished two phase 3 studies in China, and its manufacturer applied for Chinese approval in August 2023. It’s not fully clear if or when they intend to apply for FDA approval.

4. Imsidolimab

Imsidolimab (ANB019) aims to treat a different form of psoriasis: generalized pustular psoriasis (GPP). People with GPP develop pus-filled bumps on different parts of their body. Imsidolimab works by blocking the interleukin-36 (IL-36) receptor, a protein that causes inflammation in GPP.

People with GPP can experience sudden and dangerous skin flare-ups. Phase 2 study results published in July 2023 found that this intravenous (IV) medication may provide quick and lasting relief. Some people experienced an improvement in their symptoms in as little as 3 days. These positive effects lasted for up to 3 months at a time.

A phase 3 study found that over half of people who received a single IV dose achieved clear or almost clear skin after 4 weeks (compared to 13% who received a placebo). In a follow-up study, 100% of people who continued monthly treatment maintained clear skin.

Imsidolimab’s manufacturer is preparing an FDA approval application in 2025. If it’s approved, imsidolimab would likely be the second FDA-approved medication for GPP. The first one was Spevigo (spesolimab).

5. Vunakizumab

Vunakizumab (SHR-1314) is an under-the-skin, monoclonal antibody injection that blocks the inflammatory protein interleukin-17 (IL-17). 

Its psoriasis study results have been positive, too. Phase 3 data published in January 2025 suggests that vunakizumab is safe and effective for treating moderate-to-severe plaque psoriasis. After 12 weeks (3 months) of treatment, over 70% of people experienced significant skin improvement. These benefits were generally maintained through 1 year of treatment. 

Vunakizumab was approved in China in August 2024, but its manufacturer has not submitted a U.S. approval application to the FDA.

6. Piclidenoson

Piclidenoson (CF101) is a twice-daily tablet in the works for plaque psoriasis. It’s a type of A3 adenosine receptor (A3AR) agonist. Piclidenoson attaches to A3AR, which is a protein that’s often found on unwanted inflammatory cells in the skin. It destroys the cells after it attaches. No psoriasis medications that are currently approved work this way.

So far, phase 3 study data found that piclidenoson was significantly better than placebo at helping people achieve 75% symptom improvement within 4 months of treatment.

Another phase 3 study is now on deck for piclidenoson. It’s scheduled to start in March 2025, and it should run until 2028. The company that makes piclidenoson is expected to submit an FDA-approval application once its phase 3 trial program is complete.

7. ESK-001

ESK-001 is an oral medication being developed for moderate-to-severe plaque psoriasis. It belongs to a class of medications called TYK2 inhibitors, which work by blocking a specific pathway involved in immune system inflammation. This is similar to how Sotyktu (deucravacitinib) works, but ESK-001 is designed to be more selective — potentially improving its effectiveness and safety profile.

Early study results are promising. In a phase 2 study, people who took ESK-001 daily experienced significant skin improvement, with many achieving at least 75% symptom relief. 

Multiple phase 3 trials are now underway to further evaluate ESK-001’s effectiveness. Initial data is expected in 2026.

8. ICP-488

ICP-488 is another TYK2 inhibitor in development for plaque psoriasis. It works by targeting the TYK2 protein, similar in style to Sotyktu and ESK-001.

So far, phase 2 trials suggest that ICP-488 significantly reduces psoriasis symptoms in people with moderate-to-severe symptoms. Over three-fourths of participants who received the medication achieved at least 75% symptom improvement within 12 weeks of starting the medication.

A phase 3 trial is set to begin in 2025 to confirm these findings. If ICP-488 continues to show strong results, it could become another oral alternative to biologics for psoriasis.

9. Vibozilimod

Vibozilimod (SCD-044) is another oral medication in development for moderate-to-severe psoriasis. It’s not a TYK2 inhibitor, though. It’s a S1P1 receptor-1 agonist. This mechanism helps reduce inflammation in psoriasis while maintaining immune function.

Early studies suggest that vibozilimod has the potential to effectively reduce psoriasis symptoms. A pair of phase 2 trials are currently underway, and they're set to end in early 2025. A phase 3 study would come next.

10. Roflumilast foam

Roflumilast isn’t a new medication. It’s available in different forms and under various brand names. For example, FDA-approved Zoryve (roflumilast) cream treats plaque psoriasis, while Daliresp (roflumilast) tablets treat chronic obstructive pulmonary disease.

Roflumilast foam may be available for adult and adolescent psoriasis soon, too. This PDE-4 inhibitor is applied to the skin once daily. But where it’s applied on the body is what makes it unique. Because it’s a foam, it’s easier to apply to hairy areas of the body — especially the scalp.

The FDA is expected to make an approval decision on roflumilast foam for body and scalp psoriasis by May 2025. This foam is already approved to treat seborrheic dermatitis.

11. Biosimilars to current psoriasis treatments

A biosimilar is a “highly similar” version of another biologic. It’s meant to be a more affordable, yet equally-beneficial, alternative. It’s like a generic version of a brand-name drug.

Several biosimilars are available for use in the U.S., including some for plaque psoriasis. For instance, you may receive a Humira (adalimumab) biosimilar or a Remicade (infliximab) biosimilar instead of the original product — depending on your health insurance and infusion center. Several Stelara biosimilars have also been approved over the past year or so.

Even more biosimilars for psoriasis are slated to become available in the coming years. Keep an eye out for products such as BAT2306, which is a proposed Cosentyx (secukinumab) biosimilar.

Which medications are already approved to treat psoriasis?

No matter what type of psoriasis you have, how severe it is, or what your treatment goals are, you have several psoriasis treatment options to pick from.

Topicals

Many people can treat psoriasis with topical medications alone, such as creams, ointments, and gels. Common options include:

• Over-the-counter products like salicylic acid, coal tar, or calamine

• Topical steroids like hydrocortisone, clobetasol, or triamcinolone

• Vitamin D-based products like Vectical (calcitriol) or Dovonex (calcipotriene)

• Tazorac (tazarotene)

• Vtama (tapinarof)

• Zoryve

• Combination creams, such as those that combine a steroid with calcipotriene

Oral medications

Topical medications aren’t always enough. You may need an oral medication, too. You may take them alone or in combination with other treatments.

Tablets, capsules, and liquids such as these can treat moderate to severe psoriasis:

• Methotrexate

• Acitretin

• Neoral (cyclosporine)

• Sotyktu

• Otezla (apremilast)

Biologics

Biologic injections manage psoriasis symptoms by targeting specific parts of your immune system. You may receive a biologic by itself or in combination with other psoriasis treatments. Some are infused into a vein, while others are injected under your skin:

• Humira

• Cimzia (certolizumab pegol)

• Enbrel (etanercept)

• Remicade

• Cosentyx

• Bimzelx (bimekizumab)

• Siliq (brodalumab)

• Taltz (ixekizumab)

• Ilumya (tildrakizumab)

• Skyrizi 

• Tremfya

• Stelara (ustekinumab)

• Spevigo

Why trust our experts?

Written by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

Reviewed by:

Maria Robinson, MD, MBA

Maria Robinson, MD, MBA, is a board-certified dermatologist and dermatopathologist who has practiced dermatology and dermatopathology for over 10 years across private practice, academic, and telehealth settings. She is a fellow of the American Academy of Dermatology and the American Society of Dermatopathology.

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