{ "vercy": "1.0-draft", "publication": { "status": "research-draft", "adjudicationStatus": "unreviewed", "publishableCanonical": false, "generatedAt": "2026-09-12T09:40:27Z", "providers": [ "Codex" ], "breadth": "recalled by Codex without web access - no source was read", "missingProviders": [], "pass": 2, "cost": { "grok": { "seconds": 19.4, "error": "Reading additional input from stdin...\nOpenAI Codex v0.153.4\n--------\nworkdir: R:\\02_PROJECTS\\02_Meta_Models_Platforms\\Ver.cy\\current\\thing-registry-backlog\nmodel: gpt-6-astra\nprovider: openai\napproval: never\nsandbox: read-only\nreasoning effort: none\nreasoning summaries: none\nsession id: 01a094fc-1d8d-7c01-a62d-075421a49633\n--------\nuser\nDescribe what is already known about one registered thing. Answer as JSON only, no prose around it.\n\nThing: fenspiride\nSense to describe: (none recorded)\nDomain code: PHY.MAT\nAlso known as: (none)\n\n\nContext for this batch of 1001 things:\n# Batch 043: 1001 regi", "usd": 0.0, "recall": true }, "codex": { "seconds": 82.4, "error": "Reading additional input from stdin...\nOpenAI Codex v0.153.4\n--------\nworkdir: R:\\02_PROJECTS\\02_Meta_Models_Platforms\\Ver.cy\\current\\thing-registry-backlog\nmodel: gpt-6-astra\nprovider: openai\napproval: never\nsandbox: read-only\nreasoning effort: none\nreasoning summaries: none\nsession id: 01a094fc-1d9c-7501-8387-07265cc219d2\n--------\nuser\nYou are drafting a Vercy meta-model for one registered thing. Answer as JSON only, no prose around it.\n\nThing: fenspiride\nRegistry id: vr.tr.fenspiride\nPlane / domain: PHY / PHY.MAT\nRegistry definition: (none recorded)\nNames folded into this entry: (none)\n\n\nCo" } }, "enrichment": { "pass": 3, "engine": "claude", "producedAt": "2026-10-06T12:00:00Z", "ingestedAt": "2026-10-06T08:54:14+00:00", "fields": [ "agent_conduct", "ethics", "failure_modes_and_hazards", "owners", "visual_identification" ] }, "gate": { "passed": true, "version": "1.0", "at": "2026-10-07T10:10:31+00:00", "evidence": [ "completeness 1.00", "sense: Wikidata description", "2 live sources", "review by codex: pass" ] } }, "metaModel": { "id": "THING-Q518027", "registryId": "vr.tr.fenspiride", "name": "fenspiride", "version": "0.1.0-research.1", "entryKind": "thing", "family": "Thing Registry", "domain": [ "PHY.MAT" ], "status": "research-draft" }, "canonicalUrl": "https://ver.cy/models/thing/q518027/", "model": { "registry_id": "vr.tr.fenspiride", "name": "fenspiride", "purpose": "Enable an agent to recognise fenspiride, assess the identity and condition of a material sample, and determine which handling or use decisions require chemical, safety or regulatory evidence.", "definition": "Fenspiride is a synthetic spirocyclic pharmaceutical substance formerly used for respiratory symptoms because of its anti-inflammatory and bronchoconstriction-reducing effects, but withdrawn in the European Union because of cardiac rhythm risks.", "scope_statement": "This model owns the substance identity of fenspiride under vr.tr.fenspiride in PHY / PHY.MAT, including material form, quality, measured properties, biological evidence and substance-level restrictions; salts and preparations remain explicitly related forms rather than interchangeable identities.", "in_scope": [ "Fenspiride molecular identity and evidence-backed identifier mappings", "Free-base versus salt form, composition, purity and analytical identity", "Physical state, solubility, thermal behaviour and storage stability under recorded conditions", "Substance-level pharmacological and cardiac safety evidence", "Jurisdiction-, date- and activity-specific restrictions relevant to handling or use" ], "out_of_scope": [ "Finished medicine formulations, brands, packaging and product authorisations as independent entities", "Patient diagnosis, prescribing, dosing and treatment selection", "Manufacturing routes, production equipment and process optimisation", "Respiratory diseases and cardiac disorders as disease models", "Independent models for impurities, metabolites and analytical reference materials" ], "distinguishing_features": [ "Match molecular connectivity to 8-(2-phenylethyl)-1-oxa-3,8-diazaspiro[4.5]decan-2-one rather than accepting a respiratory-drug label as identity. [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/Fenspiride)", "For the neutral parent, check agreement with formula C15H20N2O2, PubChem CID 3344 and InChIKey FVNFBBAOMBJTST-UHFFFAOYSA-N; formula alone is insufficient. [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/Fenspiride)", "Distinguish the parent from fenspiride hydrochloride by counterion evidence: PubChem represents the hydrochloride separately as CID 68626 with formula C15H21ClN2O2. [PubChem hydrochloride](https://pubchem.ncbi.nlm.nih.gov/compound/68626)", "Distinguish isolated fenspiride material from a containing medicine by the presence of excipients, other ingredients and a finished-product identity." ], "characteristics": [ { "name": "Molecular identity", "kind": "category", "unit_or_values": "Verified structure identifier and parent-compound identifier; matched, conflicting or unresolved", "why_it_matters": "Prevents names, related compounds and salt records from being treated as sufficient proof of identity." }, { "name": "Material form", "kind": "category", "unit_or_values": "Free base, hydrochloride, other evidenced salt, mixture or unresolved; hydration and solvation recorded separately", "why_it_matters": "Determines which composition, property values and analytical calculations apply." }, { "name": "Fenspiride content", "kind": "measurement", "unit_or_values": "% mass fraction or mg/g, with as-is or dry basis and parent-equivalent or salt basis", "why_it_matters": "Makes assay results comparable without confusing salt mass, water content and active-moiety mass." }, { "name": "Impurity and residual-solvent profile", "kind": "measurement", "unit_or_values": "Identity and concentration in % or mg/kg, with method, detection limits and unidentified components", "why_it_matters": "Supports assessment of material suitability beyond a single nominal purity value." }, { "name": "Physical and solid-state condition", "kind": "state", "unit_or_values": "Observed phase, crystalline or amorphous character, evidenced solid form, temperature in °C and pressure in kPa", "why_it_matters": "Keeps observations tied to the actual sample and conditions." }, { "name": "Conditional solubility and ionisation", "kind": "measurement", "unit_or_values": "Solubility in mg/mL or mol/L with solvent, pH, temperature and material form; pKa with method and conditions", "why_it_matters": "Supports preparation and interpretation of solutions without transferring values between incompatible forms." }, { "name": "Thermal behaviour", "kind": "measurement", "unit_or_values": "Melting, transition or decomposition temperature in °C with method; boiling point only if experimentally applicable", "why_it_matters": "Prevents a decomposition event or salt-specific value from being presented as a universal constant." }, { "name": "Stability qualification", "kind": "state", "unit_or_values": "Supported within tested conditions, changed, outside qualification or unknown; linked storage history and retest date", "why_it_matters": "Determines whether earlier identity and assay evidence still supports the present material." }, { "name": "Biological evidence context", "kind": "relation", "unit_or_values": "Linked study, endpoint, test system, concentration or exposure, material form and evidence limitations", "why_it_matters": "Separates measured biological effects from proposed mechanisms and clinical conclusions." }, { "name": "Handling hazard classification", "kind": "category", "unit_or_values": "Form-specific GHS classification, jurisdiction, source and revision date; exposure limit with units or explicitly unestablished", "why_it_matters": "Clinical cardiac risk does not itself establish a laboratory hazard classification or occupational exposure limit." }, { "name": "Regulatory applicability", "kind": "relation", "unit_or_values": "Authority, jurisdiction, affected product or substance, activity, decision, effective date and verification date", "why_it_matters": "Separates medicinal marketing decisions from restrictions on research, possession, transport or disposal." } ], "affordances": [ "Resolve a name or supplier record to the parent structure and flag salt or identifier conflicts.", "Compare analytical results with a stated material specification and identify missing identity or quality evidence.", "Convert salt-basis content to parent-equivalent content when composition, stoichiometry and assay basis are established.", "Select form- and condition-matched property evidence for a proposed analysis or solution preparation.", "Flag proposed uses requiring review of cardiac safety evidence or jurisdiction-specific restrictions.", "Route uncertain, degraded or out-of-specification material for further testing, quarantine or an applicable disposal procedure." ], "agent_conduct": { "may": [ "Describe fenspiride's former uses and why it was withdrawn in the European Union.", "Warn people who still hold old stock that it is no longer recommended." ], "must_not": [ "Recommend, supply or dose it for anyone, including children.", "Help obtain it from sources where it has been withdrawn.", "Downplay the heart rhythm risk behind its withdrawal." ], "requires_human": [ "Any decision about treating cough or respiratory illness." ] }, "ethics": { "considerations": [ "It was widely given to children for minor illness; withdrawal shows the duty to act on safety signals." ], "affected_parties": [ "Children and parents", "Patients", "Pharmacists" ] }, "owners": { "steward": "Medicines regulators decide its status; marketing authorisation holders answer for stock where it remains licensed.", "master_systems": [ "National medicines registers" ] }, "visual_identification": [ "Was supplied as syrups or tablets; identity is confirmed by label and pharmacy records." ], "failure_modes_and_hazards": [ "Can prolong the QT interval and trigger dangerous heart rhythms." ], "what_it_is_for": [ "Fenspiride is encountered in historical pharmaceutical records, analytical reference materials and research on substances formerly used for respiratory symptoms.", "Its identity matters when examining legacy medicinal products or studying the cardiac safety concerns associated with its withdrawal." ], "standards_and_regulation": [ "The Anatomical Therapeutic Chemical classification maintained by the WHO Collaborating Centre for Drug Statistics Methodology assigns fenspiride code R03DX03 under other systemic drugs for obstructive airway diseases." ] }, "sources": [ { "id": "wikidata", "title": "Wikidata item Q518027: fenspiride", "url": "https://www.wikidata.org/wiki/Q518027", "url_status": "live", "what_it_supports": "identity and sense of the item", "checked_by": "wikidata-api" }, { "id": "wikipedia-en", "title": "Wikipedia: Fenspiride", "url": "https://en.wikipedia.org/wiki/Fenspiride", "url_status": "live", "what_it_supports": "general description of the item", "checked_by": "wikidata-api sitelink" } ], "structure": { "bundles": [ { "id": "fenspiride-identity-and-form", "name": "Fenspiride identity and form", "description": "Establish which molecular entity and material form a fenspiride record represents.", "rationale": "Parent-compound, hydrochloride and medicine names can otherwise collapse into one ambiguous identity.", "layers": [ { "id": "parent-structure", "name": "Parent structure", "description": "Anchor the registry entry to molecular connectivity.", "findings": [ { "id": "structure-backed-identification", "name": "Structure-backed identification", "description": "Recognition requires agreement between the claimed fenspiride identity, a structural reference and sample evidence appropriate to the task.", "questions": [ { "text": "Which structural identifier anchors this record to the fenspiride parent?", "kind": "definition", "id": "structure-backed-identification-q01" }, { "text": "Which analytical evidence supports the sample's claimed molecular identity?", "kind": "measurement", "id": "structure-backed-identification-q02" } ] } ] }, { "id": "salt-and-product-boundaries", "name": "Salt and product boundaries", "description": "Keep material form and containing products explicit.", "findings": [ { "id": "counterion-and-composition", "name": "Counterion and composition", "description": "Counterions, water, solvents and excipients must be distinguished from the parent molecular identity.", "questions": [ { "text": "Is the material the free base, hydrochloride or another analytically established form?", "kind": "boundary", "id": "counterion-and-composition-q01" }, { "text": "Does the record describe isolated substance material or a finished preparation requiring a linked product model?", "kind": "boundary", "id": "counterion-and-composition-q02" } ] } ] } ] }, { "id": "fenspiride-material-quality", "name": "Fenspiride material quality", "description": "Assess what a particular material lot contains and whether its evidence supports the intended use.", "rationale": "Nominal fenspiride identity does not establish assay basis, impurity content or suitability.", "layers": [ { "id": "assay-and-equivalence", "name": "Assay and equivalence", "description": "Interpret content measurements against the actual material composition.", "findings": [ { "id": "explicit-content-basis", "name": "Explicit content basis", "description": "Keep measured mass content separate from chromatographic area percentage and make salt-to-parent conversions auditable.", "questions": [ { "text": "Does the reported assay measure mass content, molar content or chromatographic area percentage?", "kind": "measurement", "id": "explicit-content-basis-q01" }, { "text": "Which counterion stoichiometry, water correction and reference-standard assignment support any parent-equivalent calculation?", "kind": "provenance", "id": "explicit-content-basis-q02" } ] } ] }, { "id": "impurities-and-suitability", "name": "Impurities and suitability", "description": "Connect impurity evidence to a defined intended use.", "findings": [ { "id": "qualified-lot-assessment", "name": "Qualified lot assessment", "description": "Suitability depends on documented criteria and the method's ability to detect relevant non-fenspiride components.", "questions": [ { "text": "Which impurities, residual solvents and unidentified peaks were measured, and with what reporting limits?", "kind": "measurement", "id": "qualified-lot-assessment-q01" }, { "text": "Which specification supports accepting this lot for the proposed analytical or research use?", "kind": "action", "id": "qualified-lot-assessment-q02" } ] } ] } ] }, { "id": "fenspiride-physical-state-and-stability", "name": "Fenspiride physical state and stability", "description": "Capture properties and changes of the identified material under explicit conditions.", "rationale": "Solubility, thermal measurements and storage conclusions require form-specific evidence.", "layers": [ { "id": "conditional-physical-properties", "name": "Conditional physical properties", "description": "Describe solid-state, thermal and solution behaviour without merging incompatible measurements.", "findings": [ { "id": "form-matched-property-evidence", "name": "Form-matched property evidence", "description": "A property value is usable only when its material form, conditions and measurement status are known.", "questions": [ { "text": "Which solid form and experimental conditions underlie each thermal or solubility value?", "kind": "measurement", "id": "form-matched-property-evidence-q01" }, { "text": "Were pH-dependent solution properties measured for the parent, the hydrochloride or another preparation?", "kind": "boundary", "id": "form-matched-property-evidence-q02" } ] } ] }, { "id": "storage-and-change", "name": "Storage and change", "description": "Determine whether current material remains covered by earlier quality evidence.", "findings": [ { "id": "evidence-supported-retest", "name": "Evidence-supported retest", "description": "Storage decisions require documented exposure history and appropriate evidence of chemical or physical change.", "questions": [ { "text": "What stability data support the assigned storage conditions and retest interval for this form?", "kind": "provenance", "id": "evidence-supported-retest-q01" }, { "text": "Which observed changes or storage excursions require repeat identity, assay or impurity testing?", "kind": "action", "id": "evidence-supported-retest-q02" } ] } ] } ] }, { "id": "fenspiride-biological-and-cardiac-evidence", "name": "Fenspiride biological and cardiac evidence", "description": "Represent biological claims and cardiac safety findings with their experimental and clinical limits.", "rationale": "Historical respiratory use and cardiac safety evidence materially affect how an agent interprets proposed uses.", "layers": [ { "id": "pharmacological-claim-context", "name": "Pharmacological claim context", "description": "Separate measured effects, proposed mechanisms and historical therapeutic uses.", "findings": [ { "id": "traceable-biological-claims", "name": "Traceable biological claims", "description": "Each pharmacological claim needs its own endpoint, material identity and evidence context.", "questions": [ { "text": "Which primary studies support each proposed receptor, anti-inflammatory or respiratory effect?", "kind": "provenance", "id": "traceable-biological-claims-q01" }, { "text": "What test system, material form and concentration or exposure produced the reported effect?", "kind": "measurement", "id": "traceable-biological-claims-q02" } ] } ] }, { "id": "cardiac-safety-signal", "name": "Cardiac safety signal", "description": "Preserve evidence relevant to repolarisation and arrhythmia risk.", "findings": [ { "id": "qt-and-proarrhythmia-evidence", "name": "QT and proarrhythmia evidence", "description": "EMA's review linked fenspiride to QT prolongation and proarrhythmic potential, including torsades de pointes, drawing on clinical reports and nonclinical evidence including hERG studies. [EMA referral](https://www.ema.europa.eu/en/medicines/human/referrals/fenspiride-containing-medicinal-products)", "questions": [ { "text": "Which clinical reports and nonclinical studies support each cardiac endpoint, and what limitations do they report?", "kind": "provenance", "id": "qt-and-proarrhythmia-evidence-q01" }, { "text": "How should the documented cardiac signal constrain evaluation of the proposed use without inventing a safe exposure threshold?", "kind": "action", "id": "qt-and-proarrhythmia-evidence-q02" } ] } ] } ] }, { "id": "fenspiride-restrictions-and-handling", "name": "Fenspiride restrictions and handling", "description": "Connect regulatory history and material hazards to the exact proposed activity.", "rationale": "Medicinal withdrawal and laboratory handling requirements concern different decisions and need separately applicable evidence.", "layers": [ { "id": "medicinal-regulatory-history", "name": "Medicinal regulatory history", "description": "Record dated decisions and the products and activities they cover.", "findings": [ { "id": "jurisdiction-specific-withdrawal", "name": "Jurisdiction-specific withdrawal", "description": "In May 2019, EMA's safety committee recommended revoking marketing authorisations for fenspiride medicines because of heart rhythm risks; the record must preserve the decision's jurisdiction, procedural stage and product scope. [EMA referral](https://www.ema.europa.eu/en/medicines/human/referrals/fenspiride-containing-medicinal-products)", "questions": [ { "text": "Which authoritative decision establishes the applicable status, effective date and affected products in the target jurisdiction?", "kind": "provenance", "id": "jurisdiction-specific-withdrawal-q01" }, { "text": "Does that decision govern the proposed activity, or is separate evidence needed for research supply, import or possession?", "kind": "boundary", "id": "jurisdiction-specific-withdrawal-q02" } ] } ] }, { "id": "material-handling-controls", "name": "Material handling controls", "description": "Determine applicable controls for the identified form and condition.", "findings": [ { "id": "form-specific-hazard-evidence", "name": "Form-specific hazard evidence", "description": "Use current, applicable hazard documentation for the material rather than inferring GHS classes or occupational limits from medicinal safety findings.", "questions": [ { "text": "Which current safety data sheet and authoritative classification apply to this form, concentration and jurisdiction?", "kind": "provenance", "id": "form-specific-hazard-evidence-q01" }, { "text": "Which documented controls govern handling, storage, transport and disposal for the proposed activity?", "kind": "action", "id": "form-specific-hazard-evidence-q02" } ] } ] } ] }, { "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.", "rationale": "A model that cannot be lined up against existing standards, identifiers and practice cannot be adopted by anyone who already uses them.", "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.", "evidence": [ "This account is recalled knowledge, without source consultation.", "Verify exact historical indications and present regulatory status separately for each jurisdiction.", "Physical constants, purity specifications, GHS classification and occupational exposure limits are omitted because they are not confidently recalled." ], "questions": [ { "id": "evidence-confidence-notes-q01", "text": "Which of these check these first hold for the sense of fenspiride this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-kinds", "name": "Kinds and varieties", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "Fenspiride free base", "Fenspiride hydrochloride" ], "questions": [ { "id": "evidence-kinds-q01", "text": "Which of these kinds and varieties hold for the sense of fenspiride this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-identifiers", "name": "Identifiers and schemes", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ { "scheme": "International Nonproprietary Name (INN)", "value_or_pattern": "fenspiride", "note": "Names the active substance rather than a particular medicinal product." }, { "scheme": "CAS Registry Number", "value_or_pattern": "5053-06-5", "note": "Identifies fenspiride free base; the hydrochloride has a separate registry identity." }, { "scheme": "Molecular formula", "value_or_pattern": "C15H20N2O2", "note": "Formula of the free base, excluding hydrochloride and any solvation." } ], "questions": [ { "id": "evidence-identifiers-q01", "text": "Which of these identifiers and schemes hold for the sense of fenspiride this model covers, and on what evidence?", "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.", "evidence": [ "Following an EMA safety review, EU marketing authorisations for fenspiride-containing medicines were revoked in 2019 because of QT prolongation and torsades de pointes risk." ], "questions": [ { "id": "evidence-standards-and-regulation-q01", "text": "Which of these standards and regulation hold for the sense of fenspiride this model covers, and on what evidence?", "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.", "evidence": [ "Historical use in oral medicines for symptomatic treatment of cough associated with respiratory disease.", "Use as the hydrochloride salt in medicinal formulations." ], "questions": [ { "id": "evidence-real-world-use-q01", "text": "Which of these real-world use hold for the sense of fenspiride this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-measurements", "name": "Typical measurements", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ { "quantity": "Molar mass of the free base", "typical_range": "260.33", "unit": "g/mol" } ], "questions": [ { "id": "evidence-measurements-q01", "text": "Which of these typical measurements hold for the sense of fenspiride this model covers, and on what evidence?", "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.", "evidence": [ "Prolongation of the cardiac QT interval.", "Risk of torsades de pointes, a potentially fatal ventricular arrhythmia.", "Confusing free-base quantities with hydrochloride quantities can introduce errors in composition or dose calculations." ], "questions": [ { "id": "evidence-failure-modes-and-hazards-q01", "text": "Which of these failure modes and hazards hold for the sense of fenspiride this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-regional-variation", "name": "Regional variation", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "The EU withdrawal is a jurisdiction-specific regulatory action; availability and authorisation elsewhere require separate verification." ], "questions": [ { "id": "evidence-regional-variation-q01", "text": "Which of these regional variation hold for the sense of fenspiride this model covers, and on what evidence?", "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.", "evidence": [ { "name": "Fenspiride hydrochloride", "difference": "The hydrochloride is a salt of fenspiride with a chloride counterion and a different formula mass from the free base." }, { "name": "Fenspiride-containing medicine", "difference": "A medicine is a formulated product with a specified strength, dosage form and excipients; fenspiride is its active substance." } ], "questions": [ { "id": "evidence-neighbours-q01", "text": "Which of these neighbouring kinds and how to tell them apart hold for the sense of fenspiride this model covers, and on what evidence?", "kind": "provenance" } ] } ] } ] } ] }, "openQuestions": [ "Which authoritative CAS and EC identifier mappings distinguish the parent from the hydrochloride and resolve conflicting synonym records?", "Which measured melting or decomposition temperatures, solubilities, pKa values and solid forms are supported by primary evidence for each material form?", "Which validated analytical methods, impurity criteria and stability data support material qualification for the intended use?", "Which primary pharmacology and cardiac studies establish exposure-response relationships, and which mechanistic interpretations remain uncertain?", "What current medicinal, research-supply, import, GHS and occupational-exposure requirements apply in the intended jurisdiction, and where are authoritative values absent?" ], "statistics": { "bundles": 6, "layers": 11, "findings": 19, "questions": 29 } }