New IBD Treatments in 2026: What Patients Should Know

Between 2022 and 2025, the FDA approved several newer IBD treatments for Crohn's disease and ulcerative colitis, including IL-23 inhibitors, an oral JAK inhibitor, an oral S1P modulator, and the first subcutaneous form of infliximab, though these are newer mechanisms and delivery methods rather than cures (1).

The last few years have brought one of the busiest stretches of drug approvals that inflammatory bowel disease (IBD) has ever seen. Between 2022 and 2025, the U.S. Food and Drug Administration (FDA) approved several new options for Crohn's disease and ulcerative colitis, expanded existing drugs to cover both conditions, and cleared the first under-the-skin (subcutaneous) version of an older infusion medicine. If you live with Crohn's or colitis, you may have heard brand names like Skyrizi, Rinvoq, Omvoh, Velsipity, Zymfentra, or Tremfya and wondered what they actually are and whether they could matter for you.

Key Takeaways

• Risankizumab (Skyrizi), an IL-23 inhibitor, was FDA approved for Crohn's disease in 2022 and for ulcerative colitis in June 2024 (1)(2).
• Mirikizumab (Omvoh), another IL-23 inhibitor, was approved for ulcerative colitis in October 2023 and for Crohn's disease in 2025 (3)(4).
• Guselkumab (Tremfya) was approved for ulcerative colitis in September 2024 and for Crohn's disease in March 2025 (5)(6).
• Etrasimod (Velsipity), an oral S1P modulator, was approved for ulcerative colitis on October 13, 2023, joining ozanimod (Zeposia), approved for UC in 2021 (7)(8).
• Zymfentra, the first FDA-approved subcutaneous form of infliximab, was approved in October 2023 for maintenance therapy in both Crohn's disease and ulcerative colitis (9).
• IBD treatment is an actively evolving field; approvals, formulations, and indication wording change over time, so always confirm current status with your gastroenterologist (10).

IL-23 Inhibitors: A Growing Class for Crohn's and Colitis

Interleukin-23 (IL-23) is a signaling protein that drives much of the inflammation in IBD. A newer group of medicines blocks the p19 subunit of IL-23 specifically, and this class has expanded quickly. See our overview of IL-23 inhibitors for Crohn's disease for how they compare.

Risankizumab (Skyrizi) was the first specific IL-23 inhibitor approved for moderately to severely active Crohn's disease in adults, cleared by the FDA in 2022 (2). It later gained approval for moderately to severely active ulcerative colitis on June 18, 2024, supported by the Phase 3 INSPIRE induction study and the COMMAND maintenance study (1). If you are weighing IL-23 options, our comparison of Skyrizi versus Stelara for Crohn's disease walks through how these mechanisms differ.

Mirikizumab (Omvoh) was FDA approved for moderately to severely active ulcerative colitis in October 2023 and later for Crohn's disease in 2025; its Crohn's approval was based on the VIVID-1 trial (3)(4). It is a humanized antibody that binds the p19 subunit of IL-23 (3).

Guselkumab (Tremfya), already used for psoriasis and psoriatic arthritis, was approved for ulcerative colitis in September 2024 (based on the Phase 3 QUASAR study) and for Crohn's disease in March 2025 (5)(6). It is notable for offering both subcutaneous and intravenous induction options (6).

JAK Inhibitors: Oral Pills That Work Inside Cells

Janus kinase (JAK) inhibitors are small-molecule pills that block inflammatory signaling pathways from inside immune cells. Because they are oral rather than injected or infused, some patients find them more convenient.

Upadacitinib (Rinvoq) is the most prominent JAK inhibitor in IBD. It was FDA approved for moderately to severely active ulcerative colitis in March 2022 and for moderately to severely active Crohn's disease in May 2023, with the Crohn's approval supported by the U-EXCEED, U-EXCEL, and U-ENDURE trials (10). In October 2025, the FDA approved an updated indication statement clarifying where upadacitinib fits relative to other therapies in IBD (10). JAK inhibitors carry boxed safety warnings about risks such as serious infections, blood clots, and cardiovascular events, so they are typically used after other treatments and require careful monitoring (10). Our detailed guide to Rinvoq (upadacitinib) for Crohn's disease covers what to expect in more depth.

S1P Modulators: A Newer Oral Option for Ulcerative Colitis

Sphingosine-1-phosphate (S1P) receptor modulators are oral medicines that keep certain inflammatory immune cells from leaving the lymph nodes and reaching the gut.

Etrasimod (Velsipity) was approved by the FDA on October 13, 2023, for adults with moderately to severely active ulcerative colitis, with a recommended dose of 2 mg once daily; approval was based on the ELEVATE UC 52 and ELEVATE UC 12 trials (7). It became the second S1P modulator for ulcerative colitis, following ozanimod (Zeposia), which the FDA approved for moderately to severely active UC in May 2021 (7)(8). As of 2026, S1P modulators in this class are approved for ulcerative colitis rather than Crohn's disease (7).

New Delivery: Subcutaneous Infliximab

Infliximab has been a cornerstone IBD medicine for years, but it has traditionally required intravenous infusions at a clinic. A newer formulation changed that.

Zymfentra (infliximab-dyyb) is the first and only FDA-approved subcutaneous form of infliximab, approved in October 2023 for maintenance treatment of adults with moderately to severely active Crohn's disease and ulcerative colitis (9). The recommended maintenance dose is 120 mg every two weeks, given as an injection after intravenous induction, and approval was based on the LIBERTY-CD and LIBERTY-UC studies (9). For some patients, an at-home injection can be more convenient than scheduled infusions. See our full guide to subcutaneous infliximab (Zymfentra) for Crohn's disease.

Biosimilars: More Choice and Often Lower Cost

Biosimilars are highly similar versions of existing biologic drugs, approved after the original loses patent protection. Several infliximab biosimilars (for example, infliximab-dyyb, infliximab-abda, and infliximab-axxq) and multiple adalimumab biosimilars are now available, and Humira (adalimumab) biosimilars expanded broadly in the U.S. starting in 2023 (11). Biosimilars are generally priced lower than the original biologic, and some carry an interchangeable designation that allows pharmacy-level substitution under state law (11). If your doctor mentions switching, our patient guide to biosimilars for Crohn's disease explains what that means for you.

Verified Approvals at a Glance

| Drug (brand) | Class / mechanism | Condition approved | Approval year | | --- | --- | --- | --- | | Risankizumab (Skyrizi) | IL-23 inhibitor | Crohn's disease | 2022 (2) | | Risankizumab (Skyrizi) | IL-23 inhibitor | Ulcerative colitis | 2024 (1) | | Mirikizumab (Omvoh) | IL-23 inhibitor | Ulcerative colitis | 2023 (3) | | Mirikizumab (Omvoh) | IL-23 inhibitor | Crohn's disease | 2025 (4) | | Guselkumab (Tremfya) | IL-23 inhibitor | Ulcerative colitis | 2024 (5) | | Guselkumab (Tremfya) | IL-23 inhibitor | Crohn's disease | 2025 (6) | | Upadacitinib (Rinvoq) | JAK inhibitor (oral) | Ulcerative colitis | 2022 (10) | | Upadacitinib (Rinvoq) | JAK inhibitor (oral) | Crohn's disease | 2023 (10) | | Etrasimod (Velsipity) | S1P modulator (oral) | Ulcerative colitis | 2023 (7) | | Ozanimod (Zeposia) | S1P modulator (oral) | Ulcerative colitis | 2021 (8) | | Infliximab-dyyb (Zymfentra) | Subcutaneous anti-TNF | Crohn's and UC (maintenance) | 2023 (9) |

What Do These New Treatments Mean for Patients?

The short version is that you now have more options than IBD patients did even a few years ago, and those options span different mechanisms and delivery methods. That matters because IBD does not respond the same way in everyone. A medicine that works well for one person may not help another, and having multiple classes (IL-23 inhibitors, JAK inhibitors, S1P modulators, and anti-TNF drugs in new formulations) gives you and your doctor more paths to try if one does not work or stops working.

It is important to be realistic. None of these are cures. They aim to reduce inflammation, induce and maintain remission, and improve quality of life. Each carries its own benefits, side effects, and monitoring requirements. Newer does not automatically mean better for your situation, and many people do well on well-established therapies. Cost, insurance coverage, how the drug is given, and your prior treatment history all factor into the decision.

How Should You Discuss New Treatments With Your GI Doctor?

Bringing up newer therapies with your gastroenterologist is reasonable and welcome. A few practical points can make the conversation productive:

• Ask which class your current treatment belongs to and what the next logical option would be if it stops working.
• Ask whether a specific drug is approved for your condition (Crohn's versus ulcerative colitis), since several drugs are approved for one but not always both.
• Ask how the medicine is given (pill, self-injection, or infusion) and what monitoring or lab tests it requires.
• Ask about known risks and boxed warnings, especially for JAK inhibitors.
• Ask about cost, biosimilar options, and what your insurance is likely to cover.

Write your questions down beforehand and bring a list of every treatment you have tried and how you responded. That history strongly shapes which newer option may be appropriate.

Frequently Asked Questions

What are the newest FDA-approved IBD treatments in 2026?

Recent FDA approvals include the IL-23 inhibitors risankizumab (Skyrizi), mirikizumab (Omvoh), and guselkumab (Tremfya); the JAK inhibitor upadacitinib (Rinvoq); the S1P modulator etrasimod (Velsipity); and subcutaneous infliximab (Zymfentra). Several were approved or expanded between 2022 and 2025 (1)(3)(6)(9).

Is there a cure for Crohn's disease or ulcerative colitis yet?

No. As of 2026, there is no cure for Crohn's disease or ulcerative colitis. The newer treatments aim to reduce inflammation, induce and maintain remission, and improve quality of life, but they manage the disease rather than eliminate it (1).

What is the difference between IL-23 inhibitors and JAK inhibitors?

IL-23 inhibitors such as risankizumab and mirikizumab are injected or infused antibodies that block a specific inflammatory protein (the p19 subunit of IL-23) (3). JAK inhibitors such as upadacitinib are oral pills that block inflammatory signaling inside immune cells and carry boxed safety warnings (10).

Can I take an IBD medicine as a pill instead of an injection?

Some newer treatments are oral. Upadacitinib (Rinvoq) is a JAK inhibitor pill approved for both Crohn's and ulcerative colitis, and etrasimod (Velsipity) and ozanimod (Zeposia) are oral S1P modulators approved for ulcerative colitis (7)(8)(10).

What is subcutaneous infliximab and how is it different?

Subcutaneous infliximab (Zymfentra) is an under-the-skin injection version of infliximab approved in 2023 for maintenance therapy in Crohn's disease and ulcerative colitis, given as 120 mg every two weeks after intravenous induction. It can be administered at home rather than requiring a clinic infusion (9).

Are biosimilars as effective as the original biologic drugs?

Biosimilars are highly similar to their reference biologic and must meet FDA standards for safety and effectiveness. Several infliximab and adalimumab biosimilars are available for IBD, are typically priced lower, and some are designated interchangeable (11).

Which new drug is best for my IBD?

There is no single best drug. The right option depends on whether you have Crohn's disease or ulcerative colitis, your disease severity, prior treatments, other health conditions, and insurance coverage. This is a decision to make with your gastroenterologist (10).

This article is for general educational purposes only and is not medical advice. It does not replace consultation with a qualified healthcare professional. Drug approvals, indications, and safety information change over time. Always discuss treatment decisions with your gastroenterologist or healthcare provider before starting, stopping, or changing any medication.

References

1. AbbVie. U.S. FDA Approves SKYRIZI (risankizumab-rzaa) for Ulcerative Colitis. June 18, 2024. https://news.abbvie.com/2024-06-18-U-S-FDA-Approves-SKYRIZI-R-risankizumab-rzaa-for-Ulcerative-Colitis,-Expanding-AbbVies-Portfolio-Across-Inflammatory-Bowel-Disease
2. AbbVie / PR Newswire. SKYRIZI (risankizumab-rzaa) Receives FDA Approval as the First and Only Specific IL-23 to Treat Crohn's Disease in Adults. 2022. https://www.prnewswire.com/news-releases/skyrizi-risankizumab-rzaa-receives-fda-approval-as-the-first-and-only-specific-interleukin-23-il-23-to-treat-moderately-to-severely-active-crohns-disease-in-adults-301570300.html
3. Eli Lilly and Company. Lilly's Omvoh (mirikizumab-mrkz) approved by U.S. FDA for adults with ulcerative colitis. 2023. https://lilly.gcs-web.com/news-releases/news-release-details/lillys-omvoh-mirikizumab-mrkz-approved-us-fda-single-injection
4. Eli Lilly and Company. FDA approves Lilly's Omvoh (mirikizumab-mrkz) for Crohn's disease. 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohr-mirikizumab-mrkz-crohns-disease
5. Johnson and Johnson. TREMFYA (guselkumab) U.S. approval for ulcerative colitis. 2024. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-achieves-u-s-approval-for-subcutaneous-induction-in-adults-with-ulcerative-colitis-now-the-first-and-only-il-23-inhibitor-with-a-fully-subcutaneous-regimen
6. Johnson and Johnson. U.S. FDA approves TREMFYA (guselkumab) for adults with moderately to severely active Crohn's disease. March 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-tremfya-guselkumab-the-first-and-only-il-23-inhibitor-offering-both-subcutaneous-and-intravenous-induction-options-for-adult-patients-with-moderately-to-severely-active-crohns-disease
7. Pfizer. U.S. FDA Approves Pfizer's VELSIPITY (etrasimod) for Adults with Moderately to Severely Active Ulcerative Colitis. October 13, 2023. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-velsipitytm-adults-moderately
8. Drugs.com. Velsipity (etrasimod) FDA Approval History (includes Zeposia/ozanimod UC context). https://www.drugs.com/history/velsipity.html
9. Celltrion / PR Newswire. ZYMFENTRA (infliximab-dyyb), the first and only FDA-approved subcutaneous infliximab. 2023. https://www.prnewswire.com/news-releases/zymfentrainfliximab-dyyb-the-first-and-only-fda-approved-subcutaneous-infliximab-now-commercially-available-in-the-us-302090981.html
10. AbbVie. FDA Approves Updated Indication Statement for RINVOQ (upadacitinib) for the Treatment of Inflammatory Bowel Disease. October 13, 2025. https://news.abbvie.com/2025-10-13-U-S-Food-and-Drug-Administration-FDA-Approves-Updated-Indication-Statement-for-RINVOQ-R-upadacitinib-for-the-Treatment-of-Inflammatory-Bowel-Disease
11. Frontiers in Pharmacology. Anti-TNF-alpha in inflammatory bowel disease: from originators to biosimilars. 2024. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1424606/full