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Ontunisertib

Phase 2

Fibrostenotic Crohn's Disease | Small molecule | Gastrointestinal |AgomAb Therapeutics NV|Last Updated: Sep 4, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment328

FDA Designations

No designations recorded

Clinical trial landscape

Ontunisertib · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT07683325NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's DiseaseFibrostenotic Crohn's Disease
RECRUITING320 Analytics
PHASE2RECRUITING
NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
Fibrostenotic Crohn's Disease
NCT07683325320
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Study Endpoints

Primary Endpoints

Proportion of participants achieving endoscopic passability of the ileal index stricture
At week 24

To evaluate the efficacy and dose-response relationship of multiple doses of ontunisertib

Absolute bioavailability of ontunisertib following oral and IV administration
Through study completion, an average of 8 days

Part 1: To determine the absolute oral bioavailability of ontunisertib

Cumulative amount of total radioactivity excreted in urine and feces
Through study completion, an average of 10 days

Part 2: To determine the mass balance recovery after a single oral dose of \[14C\]ontunisertib

Chemical structure of each metabolite accounting for ≥10% of circulating total radioactivity and Metabolite profiling accounting for >80% of total radioactivity recovered in urine and/or feces
Through study completion, an average of 10 days

Part 2: To characterize the metabolite profile in plasma and excreta (urine and/or feces) after a single oral dose of \[14C\]ontunisertib

Secondary Endpoints

Proportion of participants achieving endoscopic passability of the ileal index stricture
At week 52
Change in reliable MRE imaging features (stricture length, bowel wall thickness, prestenotic dilatation diameter) of the index stricture
At week 52 compared to baseline (week 1)
Change in total SES-CD (range, 0-56 points) (Reference: https://www.giejournal.org/article/S0016-5107(04)01878-4/abstract)
At week 52 compared to baseline
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ontunisertib HighEXPERIMENTALOntunisertib high dose
Ontunisertib MediumEXPERIMENTALOntunisertib medium dose
Ontunisertib LowEXPERIMENTALOntunisertib low dose
PlaceboEXPERIMENTALMatching placebo
OntunisertibEXPERIMENTALParticipants will receive single oral dose of ontunisertib
[14C]ontunisertib solution for infusionEXPERIMENTALParticipants will receive single IV dose of \[14C\]ontunisertib
[14C]ontunisertibEXPERIMENTALParticipants will receive single oral dose of \[14C\]ontunisertib

Interventions

NameTypeDescription
OntunisertibDRUGOral capsule
PlaceboDRUGMatching oral capsule
[14C]ontunisertibDRUGIV infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of ileal or ileocolonic CD based on clinical and endoscopic or radiological evidence established at least 12 weeks prior to signing the ICF. * Presence of at least 1 endoscopically non-passable ileal stricture. * Present stricture(s) can be naïve or anastomotic, and ...

Countries:United StatesUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 4, 2026NCT07672574Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 24, 2026NCT07683325Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 24, 2026NCT07683325Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 6, 2026NCT07683325NEW_TRIAL: changed
LOWJul 6, 2026NCT07683325NEW_TRIAL: changed

Frequently asked questions about Ontunisertib

What is Ontunisertib used for?

Ontunisertib is an investigational small molecule being developed for fibrostenotic Crohn's Disease, a gastrointestinal condition characterized by intestinal scarring and narrowing. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Ontunisertib?

Ontunisertib is being developed by AgomAb Therapeutics NV, a biopharmaceutical company. The company's ticker symbol is AGMB.

What phase is Ontunisertib in?

Ontunisertib is in Phase 2 clinical development. It is currently being evaluated in a Phase 2 trial for fibrostenotic Crohn's Disease, and it remains investigational, meaning it is not yet approved for any use.

What clinical trials is Ontunisertib in?

Ontunisertib has two clinical trials. The first is NCT07683325, a Phase 2 trial called NOV-ERA, which is recruiting 320 patients with fibrostenosing Crohn's Disease in the United States. The second is NCT07672574, a Phase 1 human mass balance study in healthy volunteers in the United Kingdom.

Is Ontunisertib the same as [14C] Ontunisertib?

Ontunisertib is the same compound as [14C] Ontunisertib, which is a radiolabeled form used in a mass balance study to track the drug's absorption, distribution, metabolism, and excretion in the body. The [14C] label is a research tool, not a different drug.