Ontunisertib in Crohn Disease: NCT07672574 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Recruiting
Recruitment status
8
Planned enrollment
2026-09-26
Primary-completion proxy
Executive view
NCT07672574 evaluates Ontunisertib in Crohn Disease. The disclosed sponsor is Sponsor not reported, the design is Interventional, and the geographic footprint is United Kingdom. The first listed primary endpoint is Absolute bioavailability of ontunisertib following oral and IV administration, assessed over Through study completion, an average of 8 days.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07672574 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Crohn Disease landscape. Drug & Asset MCP drug_fetch was queried for Ontunisertib, while Company & Deal Intelligence MCP organization_fetch was queried for Sponsor not reported.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07672574 | Ontunisertib | Phase 1 / Recruiting | Sponsor not reported | United Kingdom | Absolute bioavailability of ontunisertib following oral and IV administration Through study completion, an average of 8 days | 2026-09-26 |
| NCT07692165 | INT-210 | Phase 1/2 / Recruiting | Sponsor not reported | China | The incidence of treatment-emergent adverse events From enrollment through the safety follow-up visit on Day 92 | 2028-06-01 |
| NCT07686757 | IL-12 (SYTE) | Phase 4 / Enrolling by invitation | Sponsor not reported | United States | Proportion of Patients Requiring an Increase in IBD Disease Management Up to 18 months following initiation of therapy | 2028-06-01 |
| NCT07683325 | Ontunisertib | Phase 2 / Recruiting | Sponsor not reported | United States | Proportion of participants achieving endoscopic passability of the ileal index stricture At week 24 | 2028-12-31 |
| NCT07632573 | BDHK-2009 | Phase 1 / Recruiting | Sponsor not reported | China | To evaluate the safety and tolerability of a single dose/multiple doses of BDHK-2009 in healthy participants. From enrollment to the end of treatment at week 4. | 2026-12-31 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07672574 is a Phase 1, recruiting study with 8 planned participants. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Sequential Assignment.
The primary endpoint is “Absolute bioavailability of ontunisertib following oral and IV administration” over “Through study completion, an average of 8 days.” The retrieved endpoint description is: Part 1: To determine the absolute oral bioavailability of ontunisertib.
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 8 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Crohn Disease. These records do not establish direct evidence for NCT07672574 unless the registration number matches.
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moder…
Phase 3; n=636; Proportion of Subjects Who Achieve Clinical Remission Per Modified Mayo Score at Week 8 = 10 Participants ; Proportion of Subjects Who Achieve Clinical Remission Per Modified Mayo Score at Week 8 = 63 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05507216
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of ABX464 Once Daily for Induction Treatment in Subjects With Moder…
Phase 3; n=639; Proportion of Subjects Who Achieve Clinical Remission Per Modified Mayo Score at Week 8 = 4 Participants ; Proportion of Subjects Who Achieve Clinical Remission Per Modified Mayo Score at Week 8 = 69 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05507203
Efficacy and safety of duvakitug in patients with Crohn's disease (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial
Phase 2; n=139; Endoscopic Response(14-week) = 22.0 Pts ; Endoscopic Response(14-week) = 12.0 Pts Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42462749/
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Ontunisertib is indexed as Small molecule drug with ALK5 biology and a global stage of Phase 2. The asset profile lists AgomAb Therapeutics NV as an originator or developer.
No exact Company & Deal Intelligence profile was returned for Sponsor not reported. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Ontunisertib is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07672574
Protocol source: https://clinicaltrials.gov/study/NCT07672574
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 18 September 2026.
Ontunisertib in Crohn Disease is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Absolute bioavailability of ontunisertib following oral and IV administration and 2026-09-26 the leading decision points.
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