{ "vercy": "1.0-draft", "publication": { "status": "research-draft", "adjudicationStatus": "unreviewed", "publishableCanonical": false, "generatedAt": "2026-09-12T10:58:10Z", "providers": [ "Codex" ], "breadth": "recalled by Codex without web access - no source was read", "missingProviders": [], "pass": 2, "cost": { "grok": { "seconds": 21.2, "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: 01a09543-67d2-7c70-a2e4-7205b390f61d\n--------\nuser\nDescribe what is already known about one registered thing. Answer as JSON only, no prose around it.\n\nThing: lifitegrast\nSense to describe: (none recorded)\nDomain code: PHY.MAT\nAlso known as: (none)\n\n\nContext for this batch of 1001 things:\n# Batch 044: 1001 reg", "usd": 0.0, "recall": true }, "codex": { "seconds": 73.4, "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: 01a09543-67cb-71f1-8829-8b136e857664\n--------\nuser\nYou are drafting a Vercy meta-model for one registered thing. Answer as JSON only, no prose around it.\n\nThing: lifitegrast\nRegistry id: vr.tr.lifitegrast\nPlane / domain: PHY / PHY.MAT\nRegistry definition: (none recorded)\nNames folded into this entry: (none)\n\n\n" } }, "enrichment": { "pass": 3, "engine": "claude", "producedAt": "2026-10-06T12:00:00Z", "ingestedAt": "2026-10-06T08:54:23+00:00", "fields": [ "agent_conduct", "ethics", "failure_modes_and_hazards", "owners", "visual_identification" ] }, "gate": { "passed": true, "version": "1.0", "at": "2026-10-07T10:10:28+00:00", "evidence": [ "completeness 1.00", "sense: Wikidata description", "2 live sources", "review by codex: pass" ] } }, "metaModel": { "id": "THING-Q23044263", "registryId": "vr.tr.lifitegrast", "name": "lifitegrast", "version": "0.1.0-research.1", "entryKind": "thing", "family": "Thing Registry", "domain": [ "PHY.MAT" ], "status": "research-draft" }, "canonicalUrl": "https://ver.cy/models/thing/q23044263/", "model": { "registry_id": "vr.tr.lifitegrast", "name": "lifitegrast", "purpose": "Enable an agent to identify lifitegrast, assess the identity and quality of a material lot, and determine its suitability for a specified research or pharmaceutical use.", "definition": "Lifitegrast is a small-molecule antagonist of lymphocyte function-associated antigen-1 (LFA-1) that inhibits its interaction with intercellular adhesion molecule-1 (ICAM-1) and is used in ophthalmic treatment of dry eye disease.", "scope_statement": "This model owns lifitegrast as the chemical substance registered as vr.tr.lifitegrast in PHY / PHY.MAT, including molecular identity, material forms, lot quality, physicochemical behavior and evidence-qualified biological activity.", "in_scope": [ "Molecular structure, stereochemistry and verified substance identifiers", "Free-acid identity and relationships to salts, solvates and formulated ingredients", "Lot-specific assay, impurities, grade and traceability", "Physical form, solubility and stability under recorded conditions", "LFA-1 interaction evidence and substance-level handling constraints" ], "out_of_scope": [ "Finished ophthalmic products, their containers, excipients and administration instructions", "Patient-specific diagnosis, prescribing and treatment decisions", "Dry eye disease as a clinical condition", "Manufacturing processes, facilities and their operational qualification", "LFA-1 and ICAM-1 as independently modeled biological entities" ], "distinguishing_features": [ "Match the complete molecular structure and specified S stereochemistry; a matching name or molecular formula alone cannot exclude another stereoisomer.", "Use C29H24Cl2N2O7S and molecular weight 615.5 g/mol as identity cross-checks for the parent substance, rather than applying them unchanged to salts or solvates.", "Distinguish the active substance from a lifitegrast ophthalmic solution: solution concentration, excipients and sterility describe the product.", "Require structure-based identification to distinguish lifitegrast from other dry-eye agents; shared therapeutic use or anti-inflammatory activity does not establish identity.", "Treat LFA-1 interaction as supporting functional evidence, not as a uniquely identifying chemical test." ], "characteristics": [ { "name": "Molecular identity", "kind": "category", "unit_or_values": "Stereochemistry-explicit structure, formula C29H24Cl2N2O7S and verified identifier mappings", "why_it_matters": "Prevents confusion between the parent substance, stereoisomers and related chemical forms." }, { "name": "Molecular weight", "kind": "measurement", "unit_or_values": "615.5 g/mol for the parent substance", "why_it_matters": "Supports molar calculations when the material form and assay basis are known." }, { "name": "Material form", "kind": "category", "unit_or_values": "Parent acid, identified salt, solvate or hydrate relationship; crystalline, amorphous or dissolved state", "why_it_matters": "Determines whether measurements and mass-based calculations apply to the material being assessed." }, { "name": "Lifitegrast assay", "kind": "measurement", "unit_or_values": "% w/w with as-is, dried or anhydrous basis and analytical method", "why_it_matters": "Quantifies usable parent-substance content without mistaking chromatographic area purity for mass fraction." }, { "name": "Stereochemical purity", "kind": "measurement", "unit_or_values": "Specified stereoisomer percentage or enantiomeric excess, with chiral method", "why_it_matters": "Detects stereochemical impurities that ordinary identity or achiral purity tests may miss." }, { "name": "Impurity burden", "kind": "measurement", "unit_or_values": "% or ppm by named impurity, including residual solvents, water and elemental impurities where applicable", "why_it_matters": "Supports suitability decisions against the specification for the intended use." }, { "name": "Conditional solubility", "kind": "measurement", "unit_or_values": "mg/mL or mol/L with solvent, pH, temperature, material form and equilibration method", "why_it_matters": "Supports preparation decisions while preventing transfer of formulation behavior to bulk substance." }, { "name": "LFA-1 antagonism", "kind": "relation", "unit_or_values": "Lifitegrast-LFA-1 binding and LFA-1-ICAM-1 inhibition evidence, linked to assay conditions", "why_it_matters": "Connects chemical identity to measured biological function without implying clinical efficacy from an isolated assay." }, { "name": "Lot disposition", "kind": "state", "unit_or_values": "Unassessed, quarantined, released for specified use, rejected or retest due", "why_it_matters": "Makes permitted use depend on evidence and an applicable specification." } ], "affordances": [ "Resolve a supplier label or substance identifier to lifitegrast and flag material-form mismatches.", "Compare a lot certificate and analytical results with the specification for a stated use.", "Calculate parent-substance equivalents using assay, water content and chemical-form corrections.", "Assess whether proposed dissolution and storage conditions are supported by measured evidence.", "Compare LFA-1 activity results only after reconciling assay conditions and concentration bases.", "Link qualified substance lots to downstream products while preserving the distinction between API quality and finished-product release." ], "agent_conduct": { "may": [ "Explain lifitegrast as an LFA-1 antagonist eye drop for dry eye disease, citing official labelling.", "Report approved use, warnings and side effects from the label." ], "must_not": [ "Recommend, dose or adjust lifitegrast for a specific person.", "Suggest sharing eye drop containers between people.", "Present it as a cure for all causes of dry eye.", "Advise using it with contact lenses against the label instructions." ], "requires_human": [ "Starting or changing a patient's eye treatment." ] }, "ethics": { "considerations": [ "Eye conditions affect quality of life and independence.", "Medicine costs affect who can get treatment." ], "affected_parties": [ "Patients with dry eye", "Eye care professionals", "Pharmacists" ] }, "owners": { "steward": "The prescriber and the pharmacist for each patient; medicines regulators authorize products.", "master_systems": [ "National medicines registers" ] }, "visual_identification": [ "Identified by product label, active ingredient name and pack details rather than by appearance alone." ], "failure_modes_and_hazards": [ "Eye irritation and blurred vision after use.", "Taste disturbance.", "Contamination of shared or reused containers." ], "what_it_is_for": [ "Lifitegrast is encountered in ophthalmic drug research and pharmaceutical development involving inflammation associated with dry eye disease.", "It is used to study inhibition of the interaction between LFA-1 and ICAM-1 and the resulting effects on immune cell activity.", "Material lots are evaluated in analytical, formulation and quality-control settings for their intended research or pharmaceutical use." ], "standards_and_regulation": [ "The Anatomical Therapeutic Chemical classification maintained by the WHO Collaborating Centre for Drug Statistics Methodology assigns lifitegrast code S01XA25 within other ophthalmologicals." ] }, "sources": [ { "id": "wikidata", "title": "Wikidata item Q23044263: lifitegrast", "url": "https://www.wikidata.org/wiki/Q23044263", "url_status": "live", "what_it_supports": "identity and sense of the item", "checked_by": "wikidata-api" }, { "id": "wikipedia-en", "title": "Wikipedia: Lifitegrast", "url": "https://en.wikipedia.org/wiki/Lifitegrast", "url_status": "live", "what_it_supports": "general description of the item", "checked_by": "wikidata-api sitelink" } ], "structure": { "bundles": [ { "id": "lifitegrast-chemical-identity", "name": "Lifitegrast chemical identity", "description": "Establishes the parent structure, stereochemistry and boundary between lifitegrast and related material forms.", "rationale": "Substance recognition must survive supplier naming differences without merging salts, stereoisomers or finished solutions.", "layers": [ { "id": "parent-structure", "name": "Parent structure", "description": "Defines the molecular identity against which candidate materials are checked.", "findings": [ { "id": "structure-and-stereochemistry", "name": "Structure and stereochemistry", "description": "The prescribing information identifies an S-configured parent substance with formula C29H24Cl2N2O7S and molecular weight 615.5 g/mol. [DailyMed prescribing information](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1d4b4b61-79da-4b6f-bb19-056d111bf400).", "questions": [ { "text": "Which stereochemistry-explicit structure and analytical identity tests define lifitegrast for this record?", "kind": "definition", "id": "structure-and-stereochemistry-q01" }, { "text": "Which authoritative records verify the CAS number, PubChem CID, UNII and any applicable EC identifier against that exact structure?", "kind": "provenance", "id": "structure-and-stereochemistry-q02" } ] } ] }, { "id": "related-forms-and-products", "name": "Related forms and products", "description": "Separates chemical-form variants and formulated products from the parent identity.", "findings": [ { "id": "parent-equivalent-boundary", "name": "Parent-equivalent boundary", "description": "A salt, hydrated material or ophthalmic solution requires an explicit relationship to the parent substance and a stated quantity basis.", "questions": [ { "text": "Does the material designation mean parent lifitegrast, an identified salt or solvate, or a mixture containing lifitegrast?", "kind": "boundary", "id": "parent-equivalent-boundary-q01" }, { "text": "What form-specific conversion is needed to express the reported quantity as parent lifitegrast?", "kind": "measurement", "id": "parent-equivalent-boundary-q02" } ] } ] } ] }, { "id": "lifitegrast-lot-quality", "name": "Lifitegrast lot quality", "description": "Connects measured composition and traceability to the suitability of a specific lifitegrast lot.", "rationale": "A correct substance name does not establish stereochemical purity, pharmaceutical suitability or lot release.", "layers": [ { "id": "assay-and-related-substances", "name": "Assay and related substances", "description": "Records parent content separately from stereochemical and other impurity measurements.", "findings": [ { "id": "quantified-lot-composition", "name": "Quantified lot composition", "description": "The proposed model requires assay basis, chiral purity and relevant impurity results rather than one ambiguous purity percentage.", "questions": [ { "text": "What are the lifitegrast mass assay and stereochemical purity, and which methods and reference standards support them?", "kind": "measurement", "id": "quantified-lot-composition-q01" }, { "text": "Which process-related impurities, degradation products, residual solvents and other contaminants must be controlled for the intended use?", "kind": "boundary", "id": "quantified-lot-composition-q02" } ] } ] }, { "id": "grade-and-disposition", "name": "Grade and disposition", "description": "Associates lot history and specifications with explicit release decisions.", "findings": [ { "id": "use-specific-release", "name": "Use-specific release", "description": "Research-grade and pharmaceutical-use claims need traceable evidence; neither establishes that bulk lifitegrast is ready for ocular administration.", "questions": [ { "text": "Which manufacturer, lot identifier, certificate and approved specification establish the claimed grade?", "kind": "provenance", "id": "use-specific-release-q01" }, { "text": "Do the available results justify release for the stated use, or require quarantine, rejection or retesting?", "kind": "action", "id": "use-specific-release-q02" } ] } ] } ] }, { "id": "lifitegrast-physical-behavior", "name": "Lifitegrast physical behavior", "description": "Records condition-dependent solid-state, dissolution and degradation behavior.", "rationale": "Bulk lifitegrast properties cannot be inferred from the appearance, pH or stability of a finished eye-drop formulation.", "layers": [ { "id": "solid-state-and-dissolution", "name": "Solid state and dissolution", "description": "Relates material form to thermal measurements and solution preparation.", "findings": [ { "id": "form-conditioned-properties", "name": "Form-conditioned properties", "description": "Property values require identified material form and measurement conditions; unverified constants remain unresolved.", "questions": [ { "text": "What evidence identifies the solid form and distinguishes melting, desolvation and thermal decomposition events?", "kind": "measurement", "id": "form-conditioned-properties-q01" }, { "text": "How do pH, solvent, temperature and parent-versus-salt form affect measured solubility and precipitation?", "kind": "measurement", "id": "form-conditioned-properties-q02" } ] } ] }, { "id": "stability-and-retest", "name": "Stability and retest", "description": "Connects environmental exposure and elapsed time to chemical quality.", "findings": [ { "id": "supported-storage-window", "name": "Supported storage window", "description": "Storage and retest conditions must be supported for the actual bulk material or prepared solution.", "questions": [ { "text": "Which stability-indicating results establish sensitivity to light, moisture, temperature and solution conditions?", "kind": "measurement", "id": "supported-storage-window-q01" }, { "text": "After a storage excursion or solution hold, what evidence is required before this material can be used?", "kind": "action", "id": "supported-storage-window-q02" } ] } ] } ] }, { "id": "lifitegrast-biological-function", "name": "Lifitegrast biological function", "description": "Links lifitegrast identity to target interaction and distinguishes assay evidence from clinical product claims.", "rationale": "LFA-1 antagonism is characteristic of lifitegrast, but potency and therapeutic conclusions depend on the experimental or product context.", "layers": [ { "id": "target-interaction", "name": "Target interaction", "description": "Records the biological relationship and conditions used to measure it.", "findings": [ { "id": "lfa1-icam1-interference", "name": "LFA-1-ICAM-1 interference", "description": "Lifitegrast binds LFA-1 and blocks its interaction with ICAM-1; the label states that its exact mechanism in dry eye disease is unknown. [DailyMed prescribing information](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1d4b4b61-79da-4b6f-bb19-056d111bf400).", "questions": [ { "text": "Which binding, adhesion or cellular assay supports the stated lifitegrast activity?", "kind": "provenance", "id": "lfa1-icam1-interference-q01" }, { "text": "What potency was measured, with which endpoint, biological system, concentration basis and uncertainty?", "kind": "measurement", "id": "lfa1-icam1-interference-q02" } ] } ] }, { "id": "activity-to-product-evidence", "name": "Activity to product evidence", "description": "Controls the transfer of evidence between substance assays and ophthalmic products.", "findings": [ { "id": "context-limited-extrapolation", "name": "Context-limited extrapolation", "description": "A target assay does not establish patient benefit, and product clinical findings do not qualify an arbitrary lifitegrast lot.", "questions": [ { "text": "Which claims concern isolated lifitegrast activity, and which depend on a specified ophthalmic formulation and clinical study?", "kind": "boundary", "id": "context-limited-extrapolation-q01" }, { "text": "What additional comparability evidence is needed before substituting this material in a biological assay or formulation study?", "kind": "action", "id": "context-limited-extrapolation-q02" } ] } ] } ] }, { "id": "lifitegrast-handling-and-regulatory-context", "name": "Lifitegrast handling and regulatory context", "description": "Establishes evidence-based bulk handling constraints and jurisdiction-specific links to permitted uses.", "rationale": "Patient adverse reactions, bulk chemical hazards and medicinal-product authorization answer different operational questions.", "layers": [ { "id": "bulk-exposure-and-disposal", "name": "Bulk exposure and disposal", "description": "Records hazards for the actual lifitegrast material and operation.", "findings": [ { "id": "material-specific-hazard-evidence", "name": "Material-specific hazard evidence", "description": "The model requires a matched safety data sheet and explicit uncertainty where occupational or environmental evidence is missing.", "questions": [ { "text": "Which current safety data sheet supports the GHS classification and any occupational exposure limit or internal exposure band for this material?", "kind": "provenance", "id": "material-specific-hazard-evidence-q01" }, { "text": "What containment, protective equipment and waste route are supported for weighing, dissolving or disposing of this lifitegrast lot?", "kind": "action", "id": "material-specific-hazard-evidence-q02" } ] } ] }, { "id": "jurisdiction-and-use-status", "name": "Jurisdiction and use status", "description": "Connects substance identity to dated regulatory evidence without assigning product approval to bulk material.", "findings": [ { "id": "authorization-boundary", "name": "Authorization boundary", "description": "Regulatory records must identify the jurisdiction, date, regulated entity and specific use to which they apply.", "questions": [ { "text": "Which official records establish lifitegrast substance identity and the status of relevant medicinal products in the intended jurisdiction?", "kind": "provenance", "id": "authorization-boundary-q01" }, { "text": "Which requirements attach to this bulk API and proposed use, and which belong to a finished-product authorization?", "kind": "boundary", "id": "authorization-boundary-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 description is recalled knowledge; no sources were consulted.", "Check current jurisdiction-specific prescribing information for authorization, indications and safety details.", "Solid-state forms, purity specifications, thermal properties and chemical-handling hazard classifications are not established here; the stated solution concentration describes a formulation, not the isolated substance." ], "questions": [ { "id": "evidence-confidence-notes-q01", "text": "Which of these check these first hold for the sense of lifitegrast 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": "lifitegrast", "note": "Nonproprietary name of the active pharmaceutical substance." }, { "scheme": "CAS Registry Number", "value_or_pattern": "1025967-78-5", "note": "Identifies lifitegrast as a chemical substance." }, { "scheme": "Molecular formula", "value_or_pattern": "C29H24Cl2N2O7S", "note": "Describes elemental composition, but does not uniquely specify molecular structure or stereochemistry." } ], "questions": [ { "id": "evidence-identifiers-q01", "text": "Which of these identifiers and schemes hold for the sense of lifitegrast 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": [ "Active ingredient in prescription ophthalmic solution for treating signs and symptoms of dry eye disease." ], "questions": [ { "id": "evidence-real-world-use-q01", "text": "Which of these real-world use hold for the sense of lifitegrast 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", "typical_range": "Approximately 615.48", "unit": "g/mol" }, { "quantity": "Concentration in the marketed ophthalmic solution", "typical_range": "50", "unit": "mg/mL" } ], "questions": [ { "id": "evidence-measurements-q01", "text": "Which of these typical measurements hold for the sense of lifitegrast 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": [ "Ophthalmic administration can cause instillation-site irritation.", "Altered taste, including an unpleasant taste, can occur.", "Transient reduction or blurring of vision can occur after administration.", "Hypersensitivity reactions can occur.", "Clinical response can be incomplete because dry eye disease has multiple contributing mechanisms." ], "questions": [ { "id": "evidence-failure-modes-and-hazards-q01", "text": "Which of these failure modes and hazards hold for the sense of lifitegrast 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": [ "Marketing authorization, approved indications and product availability depend on jurisdiction." ], "questions": [ { "id": "evidence-regional-variation-q01", "text": "Which of these regional variation hold for the sense of lifitegrast 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": "Xiidra", "difference": "Xiidra is a branded ophthalmic drug product containing lifitegrast; lifitegrast is the active chemical substance." }, { "name": "Cyclosporine", "difference": "Cyclosporine is a distinct immunomodulatory substance acting through calcineurin inhibition; lifitegrast targets the LFA-1-ICAM-1 interaction." }, { "name": "Artificial tears", "difference": "Artificial tears primarily lubricate or supplement the tear film; lifitegrast acts on an inflammatory cell-adhesion pathway." } ], "questions": [ { "id": "evidence-neighbours-q01", "text": "Which of these neighbouring kinds and how to tell them apart hold for the sense of lifitegrast this model covers, and on what evidence?", "kind": "provenance" } ] } ] } ] } ] }, "openQuestions": [ "Which CAS, PubChem, UNII and EC records consistently identify the parent stereochemical structure, and which instead identify related forms?", "Which solid forms, melting or decomposition measurements, pKa values and pH-dependent solubility data are supported by primary measurements?", "What validated impurity specifications and stereochemical limits apply to lifitegrast intended for pharmaceutical manufacture?", "What bulk-material stability data support storage conditions, retest periods and prepared-solution hold times?", "Which jurisdiction-specific GHS classifications, occupational exposure controls and environmental disposal requirements are substantiated for bulk lifitegrast?" ], "statistics": { "bundles": 6, "layers": 11, "findings": 17, "questions": 27 } }