A drug called ontunisertib, developed by Agomab Therapeutics, has received FDA fast-track designation for fibrostenosing Crohn’s disease — making it the first drug ever to earn that distinction for this particular form of the condition. Unlike existing Crohn’s treatments that target inflammation, ontunisertib is an ALK5 inhibitor that goes after fibrosis itself, the scarring and narrowing of the intestinal wall that can lead to bowel obstructions and surgery. If it clears its remaining clinical hurdles, it could become the first anti-fibrotic drug approved for Crohn’s disease, filling a gap that gastroenterologists have been trying to close for decades. But ontunisertib is far from the only recent development in Crohn’s treatment.
The past year has seen a wave of new approvals and guideline changes that are reshaping how the disease is managed. The FDA approved Eli Lilly’s Omvoh (mirikizumab) for Crohn’s in January 2025, followed by Johnson & Johnson’s Tremfya (guselkumab) in March 2025. AbbVie’s RINVOQ (upadacitinib) received an updated indication in October 2025. And in November 2025, the American Gastroenterological Association released new treatment guidelines recommending biologics as first-line therapy for moderate-to-severe Crohn’s — a significant shift from the step-up approach that had dominated clinical practice. This article breaks down what each of these drugs does, how they compare, what they cost, and what the new treatment landscape means for patients and caregivers.
Table of Contents
- What Is the New Crohn’s Drug That Got Fast-Track Approval, and What Does It Do?
- How Omvoh Changed the Crohn’s Treatment Landscape in 2025
- Tremfya Brings Flexible Dosing Options for Crohn’s Patients
- Comparing the New Crohn’s Biologics — Omvoh vs. Tremfya vs. RINVOQ
- New Treatment Guidelines Recommend Biologics as First-Line Therapy
- What Fibrostenosing Crohn’s Disease Means for Long-Term Care
- What the Next Year Looks Like for Crohn’s Treatment
- Conclusion
- Frequently Asked Questions
What Is the New Crohn’s Drug That Got Fast-Track Approval, and What Does It Do?
Ontunisertib works differently from every other Crohn’s drug on the market. While biologics like Omvoh and Tremfya suppress inflammatory pathways — specifically the IL-23 cytokine — ontunisertib targets the TGF-beta signaling pathway through ALK5 inhibition. In fibrostenosing Crohn’s disease, chronic inflammation causes scar tissue to build up in the intestinal wall, gradually narrowing the passage until food and waste can no longer move through. Current drugs can reduce the inflammation that triggers this process, but they cannot reverse fibrosis once it has formed. Ontunisertib aims to do exactly that. The drug completed its Phase IIa STENOVA study, which demonstrated safety and tolerability over 12 weeks with no treatment-emergent cardiac toxicity — a concern that had shadowed earlier TGF-beta pathway drugs. It is now advancing to a Phase IIb trial.
To be clear, ontunisertib has not been approved for use. Fast-track designation means the FDA will expedite its review process, allow rolling submissions, and potentially grant priority review. It does not guarantee approval. But the designation signals that the agency recognizes fibrostenosing Crohn’s as a serious condition with an unmet medical need, and that ontunisertib shows enough promise to warrant an accelerated path. For comparison, consider a patient who has been on an anti-inflammatory biologic for years and still develops intestinal strictures requiring surgery. That patient currently has no drug option to address the fibrosis directly. Ontunisertib, if approved, would be the first medication to offer that possibility — though Phase IIb and Phase III data will need to demonstrate not just safety but actual clinical benefit in reducing or reversing strictures.
How Omvoh Changed the Crohn’s Treatment Landscape in 2025
Omvoh (mirikizumab) earned FDA approval on January 15, 2025, for moderately to severely active Crohn’s disease in adults. It is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of IL-23, blocking the pro-inflammatory cytokines and chemokines that drive intestinal damage. What set Omvoh apart at the time of its approval was its data: it was the first biologic in more than 15 years to disclose two-year Phase 3 efficacy data at the time of FDA approval. The numbers from the Phase 3 VIVID-1 trial were notable. At one year, 53% of patients on mirikizumab achieved clinical remission compared to 36% on placebo. Endoscopic response — meaning visible healing of the intestinal lining — was seen in 46% of mirikizumab patients versus 23% on placebo.
These are meaningful differences, though they also reveal a limitation worth acknowledging: roughly half of patients on the drug did not achieve clinical remission at one year. Crohn’s disease is notoriously heterogeneous, and no single drug works for everyone. However, if cost is a concern — and it almost always is — Omvoh carries a significant price tag. The first year of treatment runs approximately $50,773, which drops to about $33,083 per year in subsequent years. The higher first-year cost reflects the induction phase: three IV infusions of 900mg at weeks 0, 4, and 8, followed by a transition to 300mg subcutaneous injections every four weeks for maintenance. In October 2025, the FDA approved a single-injection maintenance regimen, with U.S. availability expected in early 2026, which should simplify the ongoing dosing burden for patients managing this at home.
Tremfya Brings Flexible Dosing Options for Crohn’s Patients
On March 20, 2025, the FDA approved Tremfya (guselkumab) for moderately to severely active Crohn’s disease in adults. Tremfya is also an IL-23 inhibitor, but it distinguishes itself in one practical way: it is the first and only IL-23 inhibitor to offer both subcutaneous and intravenous induction options for Crohn’s. That flexibility matters for patients who cannot easily access infusion centers or who have strong preferences about how they receive treatment. In the GALAXI 2 and GALAXI 3 clinical trials, 47% of patients on Tremfya achieved clinical remission at week 12, compared to 20% on placebo in GALAXI 2 and 15% on placebo in GALAXI 3. For induction, patients can choose between subcutaneous injections of 400mg at weeks 0, 4, and 8, or intravenous infusions of 200mg on the same schedule. Maintenance dosing is either 100mg subcutaneously every 8 weeks or 200mg subcutaneously every 4 weeks.
Crohn’s was the fourth U.S. indication for Tremfya, which had already been approved for plaque psoriasis, psoriatic arthritis, and ulcerative colitis. Consider a patient living in a rural area, two hours from the nearest infusion center. With Tremfya, that patient could complete induction using self-administered subcutaneous injections at home, rather than making repeated trips for IV infusions. That is a genuine quality-of-life difference — though patients should discuss with their gastroenterologist whether the IV or SC induction route is more appropriate for their clinical situation, as the choice may depend on disease severity and individual response.
Comparing the New Crohn’s Biologics — Omvoh vs. Tremfya vs. RINVOQ
Choosing between these treatments involves tradeoffs that patients and their doctors need to weigh carefully. Omvoh and Tremfya are both IL-23 inhibitors, meaning they work on the same pathway but with different dosing schedules and administration options. RINVOQ (upadacitinib), on the other hand, is a JAK inhibitor — an oral pill rather than an injection or infusion — which was approved with an updated indication in October 2025 allowing its use after at least one systemic therapy when TNF blockers are clinically inadvisable. The practical differences are significant. Omvoh requires IV infusions during induction, then transitions to subcutaneous injections every four weeks.
Tremfya lets patients choose between IV and SC induction, with maintenance injections every four to eight weeks depending on the dose. RINVOQ is taken by mouth daily, which many patients prefer. However, JAK inhibitors as a class carry boxed warnings about cardiovascular events, blood clots, malignancy, and serious infections — risks that the IL-23 inhibitors do not share to the same degree. For a patient who has failed a TNF blocker like Humira or Remicade and whose doctor considers further TNF blockade inadvisable, RINVOQ is now explicitly indicated. For a patient who is biologic-naive or who wants an IL-23 pathway approach, the choice between Omvoh and Tremfya may come down to practical considerations: dosing frequency, injection versus infusion preferences, insurance coverage, and out-of-pocket cost. Neither drug has been tested head-to-head against the other in a clinical trial, so direct efficacy comparisons should be made cautiously.
New Treatment Guidelines Recommend Biologics as First-Line Therapy
In November 2025, the American Gastroenterological Association released updated treatment guidelines that represent a fundamental shift in how Crohn’s disease is managed. The new recommendations call for advanced therapies — biologics — to be used as first-line treatment for moderate-to-severe Crohn’s, rather than the traditional step-up approach where patients had to fail less effective therapies before gaining access to biologics. This matters because the old model often meant patients spent months or years on medications like corticosteroids and immunomodulators that were insufficient for their disease, accumulating intestinal damage while waiting to “qualify” for a biologic. The updated guidelines acknowledge what gastroenterologists have long observed: early intervention with effective therapy leads to better long-term outcomes and less structural damage to the gut.
Insurance companies are beginning to comply with these recommendations, though the pace of that compliance varies widely by payer and region. A word of caution, though. Updated guidelines do not automatically translate to immediate changes in insurance authorization. Patients may still face prior authorization hurdles, step therapy requirements, or appeals processes, particularly with older insurance plans that have not yet updated their formulary criteria. If a patient is denied first-line biologic therapy, the new AGA guidelines can serve as supporting documentation in an appeal — but it may still require advocacy from the prescribing physician and, in some cases, significant persistence from the patient or caregiver.
What Fibrostenosing Crohn’s Disease Means for Long-Term Care
Fibrostenosing Crohn’s disease is the subtype that most often leads to surgery. When chronic inflammation causes the intestinal wall to thicken and scar, it creates strictures — narrowed segments that can block the passage of food. About a third of Crohn’s patients develop stricturing disease within 10 years of diagnosis, and many require one or more bowel resection surgeries over their lifetime.
This is where ontunisertib’s fast-track designation carries particular weight. A patient who has already undergone two bowel resections and is running out of intestinal length to spare has no current drug that can address the underlying fibrosis. If ontunisertib’s Phase IIb trial demonstrates that it can reduce or stabilize strictures, it could change the trajectory for these patients. But that data is still forthcoming, and patients and caregivers should be cautious about treating fast-track designation as a guarantee of eventual approval.
What the Next Year Looks Like for Crohn’s Treatment
The convergence of new drug approvals, updated guidelines, and the first anti-fibrotic therapy in the pipeline makes this an unusually active period in Crohn’s disease treatment. Omvoh’s single-injection maintenance regimen is expected to become available in the U.S. in early 2026, simplifying long-term use. Ontunisertib’s Phase IIb trial will provide the first substantive efficacy data on anti-fibrotic therapy in Crohn’s.
And as insurance companies continue adjusting to the AGA’s first-line biologic recommendations, more patients should gain earlier access to advanced therapies. For caregivers and family members — particularly those managing the health of someone who also has cognitive decline or dementia — the evolving Crohn’s treatment landscape adds another layer of coordination. Biologic therapies require regular dosing schedules, monitoring for side effects, and consistent communication with gastroenterology teams. Keeping a clear record of which drugs have been tried, their outcomes, and any adverse effects is essential, especially when the patient may not be able to advocate for themselves.
Conclusion
The Crohn’s disease treatment landscape has shifted substantially in the past year. Omvoh and Tremfya have given patients two new IL-23 inhibitor options with strong clinical data. RINVOQ’s updated indication has expanded access for patients who cannot use TNF blockers. Ontunisertib’s fast-track designation has opened the door to the first anti-fibrotic therapy for a disease subtype that has had no drug-based solution.
And the AGA’s updated guidelines are beginning to dismantle the step-therapy barriers that delayed effective treatment for years. Patients and caregivers should bring these developments to their next gastroenterology appointment. Ask about whether an IL-23 inhibitor might be appropriate, whether the new guidelines support earlier access to biologics through your insurance plan, and whether fibrostenosing disease is a concern that warrants monitoring. The right drug depends on the individual patient’s disease characteristics, treatment history, and practical circumstances — but for the first time in years, there are meaningfully more options on the table.
Frequently Asked Questions
What is the difference between Omvoh and Tremfya for Crohn’s disease?
Both are IL-23 inhibitors, but they differ in dosing and administration. Omvoh requires IV infusions during induction followed by subcutaneous injections every four weeks. Tremfya offers both IV and subcutaneous induction options, with maintenance injections every four to eight weeks. No head-to-head trial has compared them directly.
What does FDA fast-track designation mean for ontunisertib?
Fast-track designation means the FDA will expedite the drug’s review process and allow rolling submission of clinical data. It does not mean the drug has been approved. Ontunisertib still needs to complete Phase IIb and Phase III clinical trials demonstrating efficacy and safety before it can be considered for approval.
How much does Omvoh cost per year?
Omvoh costs approximately $50,773 in the first year due to the IV induction phase, and approximately $33,083 per year in subsequent years for maintenance therapy. Actual out-of-pocket costs depend on insurance coverage and any available patient assistance programs from Eli Lilly.
Can I now get biologics as a first treatment for Crohn’s disease?
The AGA’s November 2025 guidelines recommend biologics as first-line treatment for moderate-to-severe Crohn’s. Insurance companies are beginning to update their policies accordingly, but some may still require step therapy or prior authorization. Your gastroenterologist can use the updated guidelines to support an appeal if initial coverage is denied.
Is RINVOQ an option if I have not tried a TNF blocker?
The updated October 2025 indication for RINVOQ allows its use after at least one systemic therapy when TNF blockers are clinically inadvisable. It is not currently indicated as a first-line therapy, and its use requires a clinical determination that TNF blockade is not appropriate for the patient.
