{"schema":"https://ver.cy/schemas/card/1.0.0","id":"vr.tr.darolutamide","code":"thing-q25091391","url":"https://ver.cy/models/thing/q25091391/","name":"darolutamide","alternateNames":[],"kind":"thing","status":"published","version":"0.1.0-research.1","language":"en","classifiers":{"family":"Thing Registry","category":"Physical world and living systems","entryKind":"thing","plane":"PHY","domain":["PHY.MAT"],"industry":[],"navPath":"","tags":[],"facets":{}},"whatItIs":"Darolutamide is a nonsteroidal androgen receptor antagonist used as an active pharmaceutical ingredient in oral treatments for prostate cancer.","purpose":"Enable an agent to recognize darolutamide, assess the identity and condition of a material sample, and determine whether evidence supports its proposed handling or use.","scope":{"in":["Molecular and stereochemical identity, with verified identifier mappings","Darolutamide content, related substances and batch-specific purity","Solid form, solubility, stability and relevant measurement conditions","Androgen receptor activity and relationships to metabolites","Evidence governing material handling, grade and permitted use"],"out":["Nubeqa tablets, their excipients, packaging and finished-product release","Patient diagnosis, treatment selection and individualized dosing","Prostate cancer and androgen receptor biology as independent models","Manufacturing routes, equipment and production operations","Ketodarolutamide as an independently characterized substance"],"boundaries":[]},"distinguishingFeatures":["Require a structure-specific identity match; the reported formula C19H19ClN6O2 and molar mass 398.85 g/mol are supporting checks rather than unique identifiers.","Check stereochemical composition against an authenticated darolutamide reference; a matching formula or nonchiral assay alone cannot establish equivalence.","Distinguish parent darolutamide from ketodarolutamide analytically; shared androgen receptor activity does not establish chemical identity.","Distinguish bulk darolutamide from a darolutamide-containing tablet or solution by recording matrix and active-substance content.","Distinguish darolutamide from other androgen receptor inhibitors through chemical identity rather than therapeutic class."],"structure":{"bundles":[{"id":"chemical-identity","name":"Chemical identity","description":"Establish what counts as darolutamide and how a record or sample demonstrates that identity.","layers":[{"id":"molecular-reference","name":"Molecular reference","description":"Connect the registry entry to an authoritative chemical identity.","findings":[{"id":"structure-and-identifiers","name":"Structure and identifiers","description":"The FDA label supplies the chemical name, formula and molecular weight used as initial identity anchors. Identifier mappings still require verification. [FDA prescribing information, section 11](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212099s008lbl.pdf).","questions":[{"text":"Which authoritative structure representation, including specified stereochemistry, defines darolutamide for this registry entry?","id":"structure-and-identifiers-q01","kind":"definition"},{"text":"Which verified CAS, PubChem, UNII or EC records match that same substance definition?","id":"structure-and-identifiers-q02","kind":"provenance"}]}]},{"id":"stereochemical-boundary","name":"Stereochemical boundary","description":"Determine which stereochemical compositions belong to the registered substance.","findings":[{"id":"stereoisomer-acceptance","name":"Stereoisomer acceptance","description":"Record stereoisomer assignments, proportions and reference-material evidence without assuming an unverified acceptance ratio.","questions":[{"text":"Which stereoisomers and proportion limits define an acceptable darolutamide material?","id":"stereoisomer-acceptance-q01","kind":"definition"},{"text":"Which validated stereoselective method establishes the composition of this sample?","id":"stereoisomer-acceptance-q02","kind":"measurement"}]}]}]},{"id":"composition-and-quality","name":"Composition and quality","description":"Determine how much darolutamide a material contains and what accompanies it.","layers":[{"id":"content-and-matrix","name":"Content and matrix","description":"Separate active-substance quantity from solvent, moisture and formulation mass.","findings":[{"id":"assay-basis","name":"Assay basis","description":"Record darolutamide content with its calculation basis, sample matrix and uncertainty.","questions":[{"text":"What darolutamide mass fraction is measured, and is it reported as-is, dry or solvent-free?","id":"assay-basis-q01","kind":"measurement"},{"text":"Is this bulk substance, a reference preparation or a formulated product requiring a separate product record?","id":"assay-basis-q02","kind":"boundary"}]}]},{"id":"impurities-and-release","name":"Impurities and release","description":"Connect impurity evidence and supplier documentation to intended use.","findings":[{"id":"batch-fitness","name":"Batch fitness","description":"Evaluate stereochemical impurities, related organic substances, residual solvents and other specified contaminants against a documented specification.","questions":[{"text":"Which impurity identities, concentrations and detection limits are supported by this batch's analytical results?","id":"batch-fitness-q01","kind":"measurement"},{"text":"Which specification and certificate support release for the declared use, and which failures require quarantine?","id":"batch-fitness-q02","kind":"action"}]}]}]},{"id":"physical-state-and-stability","name":"Physical state and stability","description":"Represent darolutamide's material form and behavior under specified conditions.","layers":[{"id":"solid-form-and-dissolution","name":"Solid form and dissolution","description":"Relate physical characterization to solvent preparation.","findings":[{"id":"conditional-physical-properties","name":"Conditional physical properties","description":"The label describes a crystalline powder with practical aqueous insolubility; quantitative preparation decisions need condition-specific measurements. [FDA prescribing information, section 11](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212099s008lbl.pdf).","questions":[{"text":"Which diffraction or thermal measurements establish this sample's solid form?","id":"conditional-physical-properties-q01","kind":"measurement"},{"text":"What solubility is measured in the proposed medium at the relevant pH, temperature and equilibration time?","id":"conditional-physical-properties-q02","kind":"measurement"}]}]},{"id":"storage-and-change","name":"Storage and change","description":"Track whether material history has altered composition or physical form.","findings":[{"id":"stability-supported-disposition","name":"Stability-supported disposition","description":"Use bulk-substance or solution stability evidence to define storage and retest decisions; do not transfer tablet shelf-life claims automatically.","questions":[{"text":"Which studies support this darolutamide material's container, temperature, light and moisture conditions?","id":"stability-supported-disposition-q01","kind":"provenance"},{"text":"What excursion, assay change or physical-form change triggers retesting or rejection?","id":"stability-supported-disposition-q02","kind":"action"}]}]}]},{"id":"biological-activity-and-transformation","name":"Biological activity and transformation","description":"Connect chemical identity to experimentally supported activity and biological transformation.","layers":[{"id":"receptor-activity","name":"Receptor activity","description":"Record what an activity experiment establishes about the tested material.","findings":[{"id":"androgen-receptor-inhibition","name":"Androgen receptor inhibition","description":"Darolutamide inhibits androgen receptor signaling. Quantitative claims require assay context and identified test material. [FDA prescribing information, section 12.1](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212099s008lbl.pdf).","questions":[{"text":"Which receptor variant, ligand concentration and biological system underpin the reported inhibition?","id":"androgen-receptor-inhibition-q01","kind":"measurement"},{"text":"Was the tested material authenticated darolutamide, a separated stereoisomer or a mixture containing other active substances?","id":"androgen-receptor-inhibition-q02","kind":"provenance"}]}]},{"id":"parent-metabolite-separation","name":"Parent-metabolite separation","description":"Keep biological transformation relationships distinct from substance identity.","findings":[{"id":"ketodarolutamide-relationship","name":"Ketodarolutamide relationship","description":"Ketodarolutamide is an active metabolite and requires a distinct identity when interpreting analytical or activity results. [FDA prescribing information, section 12.1](https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212099s008lbl.pdf).","questions":[{"text":"Does the reported concentration distinguish darolutamide from ketodarolutamide and other measured analytes?","id":"ketodarolutamide-relationship-q01","kind":"boundary"},{"text":"Which experiment supports the transformation relationship and the contribution attributed to each analyte?","id":"ketodarolutamide-relationship-q02","kind":"provenance"}]}]}]},{"id":"handling-and-use-constraints","name":"Handling and use constraints","description":"Determine which handling and use decisions are justified for the particular darolutamide material.","layers":[{"id":"occupational-handling","name":"Occupational handling","description":"Connect hazard evidence to operations involving powder or solution.","findings":[{"id":"exposure-control-evidence","name":"Exposure control evidence","description":"Record applicable safety data and exposure assessments; clinical warnings alone do not assign a bulk-material GHS classification or occupational limit.","questions":[{"text":"Which current supplier safety data and jurisdiction-specific assessments apply to this darolutamide material?","id":"exposure-control-evidence-q01","kind":"provenance"},{"text":"What documented containment, protective equipment and waste controls apply to weighing, dissolution and spill cleanup?","id":"exposure-control-evidence-q02","kind":"action"}]}]},{"id":"regulatory-and-product-links","name":"Regulatory and product links","description":"Connect substance records to permitted uses without merging them with product authorizations.","findings":[{"id":"use-eligibility","name":"Use eligibility","description":"Keep batch qualification, supplier grade and linked medicinal-product authorization as separate evidence for a proposed use.","questions":[{"text":"Which jurisdiction, date and intended use govern this material's eligibility?","id":"use-eligibility-q01","kind":"boundary"},{"text":"What qualification evidence is required before this batch can enter the proposed research or pharmaceutical workflow?","id":"use-eligibility-q02","kind":"action"}]}]}]},{"id":"evidence-and-external-alignment","name":"Evidence and external alignment","description":"What the world already says about this thing, gathered so the model can be checked against it.","layers":[{"id":"reported-evidence","name":"Reported evidence","description":"Findings from the breadth pass, kept separate from the structural claims.","findings":[{"id":"evidence-confidence-notes","name":"Check these first","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these check these first hold for the sense of darolutamide this model covers, and on what evidence?","id":"evidence-confidence-notes-q01","kind":"provenance"}]},{"id":"evidence-identifiers","name":"Identifiers and schemes","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these identifiers and schemes hold for the sense of darolutamide this model covers, and on what evidence?","id":"evidence-identifiers-q01","kind":"provenance"}]},{"id":"evidence-standards-and-regulation","name":"Standards and regulation","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these standards and regulation hold for the sense of darolutamide this model covers, and on what evidence?","id":"evidence-standards-and-regulation-q01","kind":"provenance"}]},{"id":"evidence-real-world-use","name":"Real-world use","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these real-world use hold for the sense of darolutamide this model covers, and on what evidence?","id":"evidence-real-world-use-q01","kind":"provenance"}]},{"id":"evidence-measurements","name":"Typical measurements","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these typical measurements hold for the sense of darolutamide this model covers, and on what evidence?","id":"evidence-measurements-q01","kind":"provenance"}]},{"id":"evidence-failure-modes-and-hazards","name":"Failure modes and hazards","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these failure modes and hazards hold for the sense of darolutamide this model covers, and on what evidence?","id":"evidence-failure-modes-and-hazards-q01","kind":"provenance"}]},{"id":"evidence-regional-variation","name":"Regional variation","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these regional variation hold for the sense of darolutamide this model covers, and on what evidence?","id":"evidence-regional-variation-q01","kind":"provenance"}]},{"id":"evidence-neighbours","name":"Neighbouring kinds and how to tell them apart","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these neighbouring kinds and how to tell them apart hold for the sense of darolutamide this model covers, and on what evidence?","id":"evidence-neighbours-q01","kind":"provenance"}]}]}]}]},"agentConduct":{"may":["Explain darolutamide as an androgen receptor antagonist for prostate cancer, citing official labelling.","Report approved indications, interactions and warnings from the label."],"mustNot":["Recommend, dose or adjust darolutamide for a specific person.","Advise obtaining cancer medicines without a prescription or from unverified sellers.","Present it as a cure or as effective outside approved uses without evidence.","Advise stopping hormone therapy without a clinician."],"requiresHuman":["Starting, stopping or changing cancer treatment for a patient."]},"ethics":{"considerations":["Patients with cancer are vulnerable to false hope and counterfeit drugs.","Hormone therapy affects sexual health and quality of life; decisions need informed consent."],"affectedParties":["Patients with prostate cancer","Partners and carers","Prescribers and pharmacists"]},"owners":{"steward":"The prescriber and the pharmacist for each patient; medicines regulators authorize products.","roles":[],"masterSystems":["National medicines registers"]},"relations":[{"target":"Q11173","type":"parent","note":"registry parent class"}],"interaction":{"identity":{"applicability":"required","items":["Vercy registry: vr.tr.darolutamide","Wikidata: Q25091391 (https://www.wikidata.org/wiki/Q25091391)"]},"properties":{"applicability":"required","items":["Molecular identity: Structure representation with stereochemistry; reported formula C19H19ClN6O2","Molar mass: 398.85 g/mol","Stereochemical composition: Relative stereoisomer fractions in %, with analytical method and acceptance specification","Darolutamide assay: % mass fraction on an explicitly stated as-is, dry or solvent-free basis","Related-substance profile: Individual and total impurities in %, with quantitation limits and named analytes where identified","Physical form: Observed phase, crystallinity, assigned solid form and evidence status","Conditional solubility: mg/mL or mol/L, with solvent, pH, temperature, solid form and equilibration time","Androgen receptor inhibition: IC50 or Ki in nM where measured, with assay system, receptor variant and test-material identity","Material grade and disposition: Declared grade; quarantined, released, rejected or awaiting evidence","Substance hazard assessment: Source-specific classifications and handling limits, each with jurisdiction, date and applicability"]},"recognition":{"applicability":"required","items":["Identified by product label, active ingredient name and pack details rather than by appearance alone."]},"capabilities":{"applicability":"required","items":["Match a sample or supplier record to darolutamide using structural and analytical evidence.","Compare a batch's assay, stereochemical composition and impurities with an applicable specification.","Calculate darolutamide amount from sample mass and a verified assay basis.","Assess a proposed dissolution or storage condition against material-specific evidence.","Flag missing evidence and route a batch for testing, quarantine or qualified release review.","Link darolutamide to containing products, metabolite records and jurisdiction-specific authorizations."]},"hazards":{"applicability":"required","items":["Fatigue and other side effects.","Interactions with other medicines.","Counterfeit or diverted supply."]},"interfaces":{"applicability":"required","items":["The Anatomical Therapeutic Chemical classification maintained by the WHO Collaborating Centre for Drug Statistics Methodology assigns darolutamide code L02BB06 within anti-androgens."]},"context":{"applicability":"required","items":["Darolutamide is encountered as an active pharmaceutical ingredient in medicine development, manufacturing and quality control.","Medicines containing it are used in clinical care for specified prostate cancer indications under the applicable product authorisation."]}},"sources":[{"title":"Wikidata item Q25091391: darolutamide","url":"https://www.wikidata.org/wiki/Q25091391","note":"identity and sense of the item"},{"title":"Wikipedia: Darolutamide","url":"https://en.wikipedia.org/wiki/Darolutamide","note":"general description of the item"}],"openQuestions":["Which authoritative identifier records and stereochemical composition specifications exactly match the registry's darolutamide boundary?","Which public or qualified specifications establish assay, stereoisomer and impurity acceptance limits for each intended material grade?","What verified solid forms, melting or decomposition behavior, and condition-specific solubility measurements are available, and is a boiling-point value experimentally meaningful?","Which bulk-substance and prepared-solution stability studies support storage conditions, packaging and retest intervals?","Which current substance-specific GHS classifications, occupational exposure limits or exposure bands, and disposal requirements apply in the intended jurisdiction?"],"resources":{"spec":"/models/things/publications/thing-q25091391/spec.json"},"provenance":{"origin":"thing registry research (pass 2)","builtFrom":["models/things/publications/thing-q25091391/spec.json"],"providers":["Codex"],"researchStatus":"unreviewed","generatedAt":"2026-09-12T09:00:54Z","builder":"tools/build_cards.py@1.0.0"},"completeness":{"sections":{"classifiers":"filled","whatItIs":"filled","purpose":"filled","distinguishingFeatures":"filled","structure":"filled","agentConduct":"filled","ethics":"filled","owners":"filled","relations":"filled","interaction.identity":"filled","interaction.properties":"filled","interaction.recognition":"filled","interaction.capabilities":"filled","interaction.hazards":"filled","interaction.interfaces":"filled","interaction.context":"filled","sources":"filled"},"notes":{"_gate":"Published through the thing publication gate 1.0 on 2026-10-07T10:10:29+00:00: completeness 1.00; sense: Wikidata description; 2 live sources; review by codex: pass"},"score":1.0}}