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A simpler GLP-1, plus big-market launches

This edition of Notable New Drugs includes another oral GLP-1, the first preventative treatment for COVID-19 and the most effective oral drug for plaque psoriasis.

March 9, 2026 | 8-minute read

In this article

Welcome to the Spring 2026 Optum Rx Notable New Drugs™ Report

In our latest edition of this ongoing series to highlight anticipated new drugs, we’ll review:  

  • Icotrokinra – The first oral IL-23 antagonist for the treatment of plaque psoriasis, a condition with multiple treatment options. It has favorable efficacy compared to available oral alternatives but is less effective than some injectable treatments.
  • Orforglipron – The second oral GLP-1 drug for weight loss, and the first that can be taken without meal-time restrictions.
  • Ensitrelvir – The first preventative treatment for COVID-19 following exposure to an infected individual.

These drugs are expected to receive Food and Drug Administration (FDA) approval during the first half of 2026.

The Optum Rx drug pipeline and surveillance team continuously monitors and evaluates medications in development and shares important details on upcoming drug approvals.

Please refer to our 1st Quarter Rx Outlook Report for additional technical background and supplemental sources.

Icotrokinra (Brand Name: TBD)

Expected FDA decision: March 2026

Therapeutic use

Icotrokinra is under review for the treatment of adult and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis and would be the first interleukin-23 (IL-23) receptor antagonist approved for this indication. IL-23 is a key protein in the immune system. A targeted antagonist can block IL-23 and reduce downstream effects including plaque psoriasis symptoms.1

Plaque psoriasis is a very common condition affecting about 8 million people in the U.S. Approximately 25% of cases are considered moderate-to-severe and are therefore eligible for treatment with biologics like icotrokinra.

Key points about icotrokinra

Why this drug matters: Icotrokinra provides the highest response rates when compared to available oral disease-modifying therapies approved for plaque psoriasis.

Trial notes: Icotrokinra demonstrated statistically significant higher response rates compared to both placebo and Sotyktu®. When compared indirectly, icotrokinra provides better response rates than other oral drugs, but lower response rates than some injectable biologics. 

Route of administration: Oral, once daily

Manufacturer: Johnson & Johnson

Estimated cost: Price unavailable. For comparison, the wholesale acquisition cost for a similar drug (Tremfya®) is approximately $87,000 per year, or more than 6 times the cost of alternative Humira® and Stelara®  biosimilars.

Competitive environment

Treatment for plaque psoriasis includes topical creams or ointments, light therapy, and systemic therapies. Systemic drugs travel through the bloodstream, reaching and affecting cells all over the body.

Systemic drugs include injectable biologics (including other IL-23 antagonists) and oral disease-modifying therapies like Sotyktu® and Otezla®. They are generally used in patients with higher disease activity or when topical therapy is challenging. 

Icotrokinra would be the first orally administered IL-23 antagonist. In head-to-head studies vs. Sotyktu, an orally administered tyrosine kinase 2 (TYK2) inhibitor, icotrokinra demonstrated a statistically significant improvement in the primary endpoints. The studies looked at both PASI90 and IGA responses, commonly used measures of psoriasis severity and improvement. PASI90 responses were about 55% to 57% with icotrokinra vs. 30% to 34% with Sotyktu and the IGA response was about 70% for icotrokinra vs. 50% to 54% with Sotyktu. These results not only demonstrate the superiority of icotrokinra vs. Sotyktu, but when compared indirectly, show that icotrokinra provided the highest response rates of any oral disease modifying therapy approved for plaque psoriasis. It was also generally well tolerated in the clinical trials with no major safety concerns.

Compared indirectly, icotrokinra provides similar efficacy to Stelara® (ustekinumab), an injectable IL-12/23 inhibitor with available biosimilars. Johnson & Johnson is hopeful that icotrokinra will provide similar or better response rates than Stelara and is conducting a head-to-head trial which is expected to complete in March 2026. 

When compared indirectly to other injectable biologics, such as Tremfya, icotrokinra provides lower response rates. For healthcare providers and patients who prefer the drug with the highest likelihood of treatment success, biologic injectables will likely still be selected. As with other drugs in this category, icotrokinra is being studied for additional indications, with psoriatic arthritis likely to follow the initial psoriasis approval.

For reference, the wholesale acquisition cost (WAC) for Tremfya, Johnson & Johnson’s injectable IL-23 antagonist, is approximately $87,000 per year. This cost estimate is more than six times that of the alternative Humira and Stelara biosimilars.

Orforglipron (Brand name TBD)

Expected FDA decision: April 10, 2026

Therapeutic use

Orforglipron is a GLP-1 (glucagon-like peptide-1 receptor agonist) that is under review to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.

Overweight or obesity is very common in the U.S., with an estimated 40% of the adult population living with obesity and more than 73% overweight (including obesity).

Key points about orforglipron

Why this drug matters: Potentially the second oral GLP-1 drug for weight loss, but the first with no meal-time restrictions. Received the FDA’s Commissioner’s National Priority Voucher for the weight loss indication, moving up its anticipated approval timeline to April. 

Trial notes: Orforglipron demonstrated significantly greater weight reductions compared to placebo. When compared indirectly, orforglipron provides similar reductions in body weight to oral Wegovy® (semaglutide) but less than injectable Zepbound® (tirzepatide).

Route of administration: Oral, once daily with or without food

Manufacturer: Eli Lilly

Estimated cost: Price unavailable. In the oral GLP-1 space, initial pricing of oral Wegovy was equivalent to the injectable. Using Eli Lilly’s injectable weight loss GLP-1, Zepbound, as an initial pricing benchmark, estimated cost could be a wholesale acquisition cost of $13,000 per year. However, orforglipron will bring competition to the oral weight loss GLP-1 space, providing additional downward pressure on direct-to-consumer strategies and competitive contracting.

Competitive environment

If approved, orforglipron would be the direct competitor to Novo Nordisk’s oral Wegovy and the second oral GLP-1 drug for weight loss. Across different studies, the weight reductions are similar for orforglipron compared to oral Wegovy. Overall, oral drugs for weight loss, including Wegovy, do not provide the amount of weight loss seen with injectable GLP-1 drugs like injectable Wegovy or Zepbound.

The primary differentiator for orforglipron is that it’s designed to be taken orally, without restrictions on food or liquid intake. Oral Wegovy must be taken in the morning on an empty stomach 30 minutes prior to food or any liquids except water.

Like other GLP-1 drugs, including semaglutide, orforglipron has been evaluated to treat type 2 diabetes. The trial results were positive, including in a head-to-head study demonstrating superiority for A1C reduction vs. oral semaglutide. Eli Lilly is expecting to apply for approval for a new indication for type 2 diabetes this year, with potential approval in late 2026.

For reference, the wholesale acquisition cost for Zepbound, Eli Lilly’s injectable GLP-1 drug for weight loss, is approximately $13,000 per year.

Xocova® (ensitrelvir)

Expected FDA decision: June 16, 2026

Therapeutic use

Xocova is under review to prevent COVID-19 following exposure to an infected individual. Xocova inhibits an enzyme of the COVID-19 virus that allows the virus to replicate.

COVID-19 related mortality has declined since the beginning of the pandemic, however there were still 20,000 deaths attributed to COVID-19 in 2025.

Key points about Xocova

Why this drug matters: First post-exposure preventive treatment for COVID-19 and potential future use as COVID-19 treatment. This is similar to the use of Tamiflu®, which can be used for influenza post-exposure.

Trial notes: Xocova demonstrated effectiveness in prevention of symptomatic COVID-19 within 72 hours of treatment with a significantly lower number of confirmed symptomatic cases of COVID-19 compared to placebo. The study found no cases of hospitalization nor death in the treatment nor placebo groups.

Route of administration: Oral, once daily for 5 days

Manufacturer: Shionogi 

Estimated cost: Price unavailable. For comparison, the wholesale acquisition cost for a similar drug used for treatment of COVID-19 (Paxlovid®) is approximately $1,500 per treatment course.

Competitive environment

Xocova would be the first preventive treatment for COVID-19 infection that would be effective after exposure. It would potentially have a similar place in therapy for COVID as antivirals like Tamiflu® have for influenza. In addition to this initial preventive indication, Xocova is approved to treat COVID-19 outside of the U.S. That could become a potential future use here in the U.S.

The key clinical study found a 67% reduction in the risk of developing symptoms of COVID-19. Nearly all the study participants had antibodies to COVID-19 before this exposure. It’s difficult to know if Xocova can provide protection against severe COVID-19 outcomes because there were no hospitalizations nor deaths in either the treatment nor placebo group. The study also required household contacts to be treated within 72 hours of exposure to a person with COVID-19, so Xocova’s ability to protect will likely be time sensitive.

The prevention indication for Xocova per the label is expected to be broad. However, its common use in practice is likely to be more concentrated in patients at high risk for severe COVID-19 outcomes (e.g., elderly patients, immunocompromised, smokers). 

For reference, the wholesale acquisition cost for Paxlovid, an antiviral approved to treat COVID-19, is approximately $1,500 per treatment course.

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Unless specified, all citations taken from Rx Outlook® 1st Quarter 2026

1. Johnson & Johnson. What is IL-23? Published April 29, 2024. Accessed February 9, 2026.

STATEMENT REGARDING FINANCIAL INFLUENCE: 
This article is directed solely to its intended audience about important developments affecting the pharmacy benefits business. It is not intended to promote the use of any drug mentioned in the article and neither the author, participants nor Optum Rx has accepted any form of compensation for the preparation or distribution of this article.