{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT06126354","title":"Dexamethasone/Pancreatic Clamp P&F","sponsor":"Columbia University","phases":["PHASE1"],"status":"WITHDRAWN","indication":null,"disease":"Insulin resistance"},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"no","detail":"None of INSR, SSTR5, SSTR2, SSTR4, GCGR, GHR has somatic-mutation evidence in Insulin resistance","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets: INSR in Insulin resistance","url":"https://platform.opentargets.org/evidence/ENSG00000171105/HP_0000855","date":"2026-11-11T23:32:24.735Z"},"context":[]},{"id":"human_genetic","label":"Human genetic evidence","value":"yes","detail":"INSR: germline","rule":"Any germline or somatic human genetic evidence for the target in this cancer, counted apart from animal-model and literature evidence","source":{"label":"Open Targets: INSR in Insulin resistance","url":"https://platform.opentargets.org/evidence/ENSG00000171105/HP_0000855","date":"2026-11-11T23:32:24.735Z"},"context":[{"figure":"2.6× relative probability of success, phase 1 to launch, with human genetic support","dataset":"Minikel et al., Nature 2024","years":"drug programs to 2023","caveat":"All therapy areas, mostly germline evidence; not a probability for this program."}]},{"id":"pediatric_target","label":"Pediatric target","value":"no","detail":"Not on the FDA list","rule":"Target is on FDA's Pediatric Molecular Target List (relevant targets); membership alone neither requires nor waives a study","source":{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"},"context":[]},{"id":"haematologic","label":"Haematologic cancer","value":"no","detail":"Solid tumour","rule":"From the indication, or the registry conditions when no indication matches","source":{"label":"ClinicalTrials.gov NCT06126354","url":"https://clinicaltrials.gov/study/NCT06126354","date":"2026-11-11T23:32:24.735Z"},"context":[{"figure":"Likelihood of approval from phase 1: 7.5% haematologic vs 4.6% solid","dataset":"BIO / Informa / QLS 2021","years":"2011–2020","caveat":"Population-level, not a prediction."}]}],"facts":[{"label":"INSR (via Insulin human)","text":"Evidence types in Insulin resistance: literature, genetic_association, clinical; literature listed separately from human genetics. Datasources: eva, europepmc, clinical_precedence.","source":{"label":"Open Targets: INSR in Insulin resistance","url":"https://platform.opentargets.org/evidence/ENSG00000171105/HP_0000855","date":"2026-11-11T23:32:24.735Z"}},{"label":"SSTR5 (via Octreotide Acetate)","text":"Evidence types in Insulin resistance: literature; literature listed separately from human genetics. Datasources: europepmc.","source":{"label":"Open Targets: SSTR5 in Insulin resistance","url":"https://platform.opentargets.org/evidence/ENSG00000162009/HP_0000855","date":"2026-11-11T23:32:24.735Z"}},{"label":"SSTR2 (via Octreotide Acetate)","text":"Evidence types in Insulin resistance: literature; literature listed separately from human genetics. Datasources: europepmc.","source":{"label":"Open Targets: SSTR2 in Insulin resistance","url":"https://platform.opentargets.org/evidence/ENSG00000180616/HP_0000855","date":"2026-11-11T23:32:24.735Z"}},{"label":"SSTR4 (via Octreotide Acetate)","text":"Open Targets has no association between SSTR4 and Insulin resistance.","source":{"label":"Open Targets: SSTR4 in Insulin resistance","url":"https://platform.opentargets.org/evidence/ENSG00000132671/HP_0000855","date":"2026-11-11T23:32:24.735Z"}},{"label":"GCGR (via Glucagon)","text":"Evidence types in Insulin resistance: literature, clinical; literature listed separately from human genetics. Datasources: clinical_precedence, europepmc.","source":{"label":"Open Targets: GCGR in Insulin resistance","url":"https://platform.opentargets.org/evidence/ENSG00000215644/HP_0000855","date":"2026-11-11T23:32:24.735Z"}},{"label":"GHR (via Human Growth Hormone)","text":"Evidence types in Insulin resistance: literature, clinical; literature listed separately from human genetics. Datasources: clinical_precedence, europepmc.","source":{"label":"Open Targets: GHR in Insulin resistance","url":"https://platform.opentargets.org/evidence/ENSG00000112964/HP_0000855","date":"2026-11-11T23:32:24.735Z"}}],"pending":[{"what":"Normal-tissue expression in vital organs","source":"Human Protein Atlas (ticket 36)"},{"what":"Pan-essential in cell lines","source":"DepMap (ticket 36)"},{"what":"Approved drug on this target","source":"Drugs@FDA (ticket 30)"}]},{"n":2,"question":"Can the result be trusted?","flags":[{"id":"randomised","label":"Randomised","value":"yes","detail":"Randomised allocation","rule":"Registry allocation field","source":{"label":"ClinicalTrials.gov NCT06126354","url":"https://clinicaltrials.gov/study/NCT06126354","date":"2026-11-11T23:32:24.735Z"},"context":[]},{"id":"small_denominator","label":"Small denominator","value":"yes","detail":"0 enrolled; each patient moves a rate by 100 ÷ 0 = – points","rule":"Enrolment under 30; the arithmetic is shown, not a benchmark","source":{"label":"ClinicalTrials.gov NCT06126354","url":"https://clinicaltrials.gov/study/NCT06126354","date":"2026-11-11T23:32:24.735Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"no","detail":"Absolute values of plasma glucose; Relative change in plasma glucose; Absolute values of serum insulin (and 3 more)","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT06126354","url":"https://clinicaltrials.gov/study/NCT06126354","date":"2026-11-11T23:32:24.735Z"},"context":[{"figure":"Non-OS primary endpoint: odds ratio 2.79 for a positive phase 3","dataset":"Otsuka 2021, 400 phase 3 oncology trials","years":"to 2020","caveat":"Shown with the next figure: a surrogate is easier to hit, and often a weak guide to survival."},{"figure":"52% of surrogate-to-OS correlations are low","dataset":"Prasad 2015","years":"published to 2014","caveat":"Shown with the figure above."}]},{"id":"results_overdue","label":"Results overdue","value":"no","detail":"Primary completion expected 2025-11-30; not yet due","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT06126354","url":"https://clinicaltrials.gov/study/NCT06126354","date":"2026-11-11T23:32:24.735Z"},"context":[]}],"facts":[],"pending":[{"what":"Treated and evaluable counts, assessor, confirmed response, follow-up and data cutoff","source":"Readout extraction (ticket 32)"},{"what":"Primary endpoint changed between registry versions","source":"Registry versions in the store (ticket 32)"}]},{"n":3,"question":"What must it beat?","flags":[],"facts":[],"pending":[{"what":"Control-arm result and approved therapies for the same segment, with label links","source":"Drugs@FDA, FDA labels and readouts (tickets 30, 32)"}]},{"n":4,"question":"Too crowded, or too late?","flags":[],"facts":[{"label":"Stopped on this target","text":"57 terminated, withdrawn or suspended trials of drugs against INSR; 11 give no reason. Reasons are quoted as the registry gives them on the target page.","source":{"label":"INSR: what already stopped","url":"/target/ENSG00000171105#stopped","date":"2026-11-11T23:32:24.775Z"}}],"pending":[{"what":"Programs on the target by phase and months behind the leader","source":"Programs and Drugs@FDA (ticket 33)"}]},{"n":5,"question":"Can it be approved, and stay approved?","flags":[{"id":"single_country","label":"Single-country","value":"yes","detail":"The only site is in United States","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT06126354","url":"https://clinicaltrials.gov/study/NCT06126354?tab=locations","date":"2026-11-11T23:32:24.735Z"},"context":[]},{"id":"eu_pip","label":"EU paediatric investigation plan","value":"yes","detail":"EMEA-002116-PIP01-17-M01 (Insulin human (NTRA-2112), Treatment of intestinal malabsorption in preterm infants): PM: decision on the application for modification of an agreed PIP, 28 Oct 2022; EMEA-001657-PIP01-14-M01 (Glucagon, Treatment of hypoglycaemia): PM: decision on the application for modification of an agreed PIP, 12 Aug 2020; compliance positive 18 Oct 2024","rule":"An EMA PIP decision (agreement, modification or waiver) lists the drug as its active substance, exact name","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-paediatric_investigation_plans-output-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_orphan","label":"EU orphan designation","value":"yes","detail":"EU/3/25/3093 positive 18 Jul 2025: Treatment of autosomal dominant polycystic kidney disease; EU/3/09/645 withdrawn 12 Jun 2009: Treatment of acromegaly; EU/3/13/1170 withdrawn 5 Aug 2013: Treatment of acromegaly; EU/3/24/2984 positive 10 Nov 2024: Treatment of autosomal dominant polycystic liver disease; +10 more","rule":"An EU orphan designation lists the drug as its active substance (exact name) or belongs to a medicine that does; withdrawn and expired designations are listed with their status","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-orphan_designations-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_authorised","label":"Authorised in the EU","value":"yes","detail":"Oczyesa: authorised since 30 Jun 2025; Insuman: authorised since 21 Feb 1997; Insulin Human Rechon: application withdrawn; Ogluo: authorised since 11 Feb 2021; +20 more","rule":"An EMA medicine record lists the drug as its active substance or INN, exact name; national-only authorisations are not in this file","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"fda_orphan","label":"FDA orphan designation","value":"not published","detail":"FDA's orphan designation database turns away automated requests, so this app does not read it; search it by hand at the link","rule":"Would be: an FDA orphan designation names the drug","source":{"label":"FDA orphan designations search","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/","date":""},"context":[]},{"id":"fda_ped_approval","label":"FDA pediatric oncology approval","value":"no","detail":"FDA's table lists no pediatric approval of Insulin human, Octreotide Acetate, Glucagon, Human Growth Hormone","rule":"FDA's Pediatric Oncology Drug Approvals table names the drug","source":{"label":"FDA Pediatric Oncology Drug Approvals (content current as of 2026-03-03)","url":"https://www.fda.gov/about-fda/oncology-center-excellence/pediatric-oncology-drug-approvals","date":"2026-11-11T23:32:24.783Z"},"context":[]},{"id":"studies_under_18","label":"Registered studies open to children","value":"yes","detail":"1310 interventional studies of Insulin human, Octreotide Acetate, Glucagon, Human Growth Hormone include patients under 18; 148 are recruiting, not yet recruiting or active","rule":"The registry's age group includes Child (birth to 17 years), which also counts studies that set no minimum age","source":{"label":"ClinicalTrials.gov search","url":"https://clinicaltrials.gov/search?intr=%22Insulin+human%22+OR+%22Octreotide+Acetate%22+OR+%22Glucagon%22+OR+%22Human+Growth+Hormone%22&aggFilters=ages%3Achild%2CstudyType%3Aint","date":"2026-11-11T23:32:24.789Z"},"context":[]}],"facts":[{"label":"Caveat","text":"Site counts are not patients per country, and trials registered only outside ClinicalTrials.gov are not covered. Where the sites are is a fact about the record, not a judgement of its quality."},{"label":"Rare pediatric disease voucher","text":"FDA, content current as of 29 Apr 2026: “As of February 3, 2026, enactment of the Consolidated Appropriations Act, 2026, the rare pediatric disease PRV program will sunset after September 30, 2029. FDA may not award any PRVs under this program after September 30, 2029.” Voucher sale prices are not shown here; they appear only as company-reported news.","source":{"label":"FDA: Rare Pediatric Disease Designation and Priority Review Voucher Programs","url":"https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs","date":"2026-11-11"}}],"pending":[{"what":"Precedent approvals for target, modality and endpoint; accelerated-approval status","source":"Drugs@FDA and FDA accelerated-approval tables (ticket 30)"}]},{"n":6,"question":"Can the sponsor finish?","flags":[],"facts":[{"label":"Sponsor","text":"Columbia University (academic or other)","source":{"label":"ClinicalTrials.gov NCT06126354","url":"https://clinicaltrials.gov/study/NCT06126354","date":"2026-11-11T23:32:24.735Z"}},{"label":"principal investigator","text":"Joshua R Cook, MD, PhD, Columbia University","source":{"label":"Person page","url":"/person/Joshua%20R%20Cook%2C%20MD%2C%20PhD","date":"2026-11-11T23:32:24.735Z"}}],"pending":[{"what":"Filed cash, quarterly spend and the runway arithmetic","source":"SEC XBRL company facts (ticket 37)"},{"what":"Sponsor's completed vs stopped oncology trials and results-reporting record","source":"Registry, by company (ticket 37)"}]}],"limits":"Public records cannot show: sales forecasts; a probability of success for this asset; full deal terms and net prices; FDA designations and action dates before approval (shown only as company-reported); clinical holds unless the company disclosed them; manufacturing; patents on unapproved drugs; whether preclinical findings have been replicated.","sources":[{"label":"ClinicalTrials.gov NCT06126354","url":"https://clinicaltrials.gov/study/NCT06126354","date":"2026-11-11T23:32:24.735Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T23:32:24.735Z"},{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"}]},"source":"ClinicalTrials.gov + Open Targets","fetchedAt":"2026-11-11T23:32:24.731Z"}