{"schema":"https://ver.cy/schemas/card/1.0.0","id":"vr.tr.galcanezumab","code":"thing-q25326707","url":"https://ver.cy/models/thing/q25326707/","name":"galcanezumab","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":"Galcanezumab is a humanized IgG4 monoclonal antibody that binds calcitonin gene-related peptide (CGRP), preventing its receptor activation, and is used to prevent migraine and treat episodic cluster headache in certain jurisdictions.","purpose":"Enable an agent to recognise galcanezumab, assess the identity and integrity of material containing it, and identify evidence-based constraints on its use.","scope":{"in":["Antibody identity, sequence reference and molecular variants","CGRP binding and functional neutralisation","Batch provenance, purity, potency and contamination","Material condition, stability and handling evidence","Jurisdiction-specific substance names and medicinal-product relationships","Substance-related safety evidence and unresolved limitations"],"out":["Emgality packaging, device mechanics and complete formulation specifications","Individual diagnosis, prescribing and treatment response","Migraine and cluster headache as diseases","Manufacturing facilities and production-process execution","CGRP biology beyond interactions needed to characterise galcanezumab"],"boundaries":[]},"distinguishingFeatures":["Identify a recombinant humanised monoclonal antibody, rather than a small-molecule CGRP antagonist; recombinant production in Chinese hamster ovary cells is documented in the [EMA product information](https://www.ema.europa.eu/en/documents/product-information/emgality-epar-product-information_en.pdf).","Require evidence of binding to the CGRP ligand rather than merely an assertion of activity somewhere in the CGRP pathway.","Require a galcanezumab-specific molecular reference: shared CGRP-neutralising activity alone cannot establish antibody identity.","Distinguish the active substance from Emgality, the medicinal product containing it, as recorded in the [EMA overview](https://www.ema.europa.eu/en/medicines/human/EPAR/emgality).","Resolve the US name galcanezumab-gnlm through its regulatory record rather than treating the suffix as evidence of a separate registry thing; see the [US prescribing information](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=33a147be-233a-40e8-a55e-e40936e28db0)."],"structure":{"bundles":[{"id":"antibody-identity","name":"Antibody identity","description":"Establish what makes a material galcanezumab.","layers":[{"id":"molecular-reference","name":"Molecular reference","description":"Anchor identity in a traceable antibody reference.","findings":[{"id":"sequence-and-variant-boundary","name":"Sequence and variant boundary","description":"Define the reference molecule and the variation compatible with its identity.","questions":[{"text":"Which authoritative heavy-chain and light-chain sequences define galcanezumab?","id":"sequence-and-variant-boundary-q01","kind":"definition"},{"text":"Which molecular variants remain within an accepted galcanezumab specification?","id":"sequence-and-variant-boundary-q02","kind":"boundary"}]}]},{"id":"name-resolution","name":"Name resolution","description":"Connect registry, scientific and regulatory names.","findings":[{"id":"substance-product-crosswalk","name":"Substance-product crosswalk","description":"Resolve aliases and identifiers while preserving the substance-product boundary.","questions":[{"text":"Which authority records connect galcanezumab, galcanezumab-gnlm and vr.tr.galcanezumab?","id":"substance-product-crosswalk-q01","kind":"provenance"},{"text":"Which verified CAS, UNII, PubChem or other identifiers denote the substance rather than a formulation?","id":"substance-product-crosswalk-q02","kind":"boundary"}]}]}]},{"id":"cgrp-neutralisation","name":"CGRP neutralisation","description":"Describe the target interaction and how retained function is demonstrated.","layers":[{"id":"ligand-recognition","name":"Ligand recognition","description":"Specify what is bound and under which conditions.","findings":[{"id":"binding-specificity","name":"Binding specificity","description":"Require direct evidence of ligand recognition and distinguish it from receptor-directed activity.","questions":[{"text":"Which CGRP forms and species variants have experimentally demonstrated binding to galcanezumab?","id":"binding-specificity-q01","kind":"definition"},{"text":"What affinity measurements are available, with ligand preparation, temperature and assay format?","id":"binding-specificity-q02","kind":"measurement"}]}]},{"id":"functional-potency","name":"Functional potency","description":"Assess whether binding produces the expected neutralising activity.","findings":[{"id":"neutralisation-assay","name":"Neutralisation assay","description":"Connect measured activity to a reference standard and a validated readout.","questions":[{"text":"Which assay demonstrates inhibition of CGRP-mediated signalling by this material?","id":"neutralisation-assay-q01","kind":"measurement"},{"text":"What reference standard and acceptance criteria support a conclusion of retained potency?","id":"neutralisation-assay-q02","kind":"action"}]}]}]},{"id":"biologic-material-quality","name":"Biologic material quality","description":"Assess the provenance and analytical quality of galcanezumab material.","layers":[{"id":"batch-and-grade","name":"Batch and grade","description":"Connect material to its origin and intended-use qualification.","findings":[{"id":"traceable-material","name":"Traceable material","description":"Separate authenticated identity from evidence permitting a particular use.","questions":[{"text":"Which manufacturer, batch record and certificate of analysis accompany the material?","id":"traceable-material-q01","kind":"provenance"},{"text":"What documentation qualifies it as research material, reference standard, drug substance or material in a released medicinal product?","id":"traceable-material-q02","kind":"boundary"}]}]},{"id":"purity-and-heterogeneity","name":"Purity and heterogeneity","description":"Characterise molecular integrity and impurities relevant to the material's stage.","findings":[{"id":"analytical-quality-profile","name":"Analytical quality profile","description":"Record aggregate, fragment, variant and contaminant results against applicable limits.","questions":[{"text":"What do validated assays show about monomer content, aggregates, fragments and molecular variants?","id":"analytical-quality-profile-q01","kind":"measurement"},{"text":"Which limits apply to host-cell residues, endotoxin and microbial contamination at this material stage?","id":"analytical-quality-profile-q02","kind":"boundary"},{"text":"Which failures or missing results require quarantine before the intended use?","id":"analytical-quality-profile-q03","kind":"action"}]}]}]},{"id":"stability-and-handling","name":"Stability and handling","description":"Determine whether a particular preparation remains within supported conditions.","layers":[{"id":"preparation-context","name":"Preparation context","description":"Identify the matrix and physical conditions governing stability.","findings":[{"id":"form-dependent-properties","name":"Form-dependent properties","description":"Attach measurements to concentration, formulation and sample state.","questions":[{"text":"Is the material bulk drug substance, an analytical preparation or part of a finished injection?","id":"form-dependent-properties-q01","kind":"boundary"},{"text":"What concentration, pH, buffer and physical state accompany each reported stability measurement?","id":"form-dependent-properties-q02","kind":"measurement"}]}]},{"id":"degradation-and-disposition","name":"Degradation and disposition","description":"Connect exposure history and integrity evidence to permitted handling.","findings":[{"id":"excursion-assessment","name":"Excursion assessment","description":"Require preparation-specific evidence before accepting exposed material.","questions":[{"text":"What temperature, light, agitation and freeze-thaw exposures are documented for this material?","id":"excursion-assessment-q01","kind":"provenance"},{"text":"Which stability study or current product instruction supports acceptance, further testing or rejection after that exposure?","id":"excursion-assessment-q02","kind":"action"}]}]}]},{"id":"authorised-use-and-safety","name":"Authorised use and safety","description":"Link galcanezumab to dated product permissions and safety evidence.","layers":[{"id":"jurisdictional-use-boundary","name":"Jurisdictional use boundary","description":"Locate use claims in a specific authorisation.","findings":[{"id":"indication-and-presentation","name":"Indication and presentation","description":"US labeling includes adult migraine prevention and episodic cluster headache treatment; the EU overview specifies migraine prophylaxis in adults with at least four migraine days monthly. Sources: [US label](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=33a147be-233a-40e8-a55e-e40936e28db0), [EMA overview](https://www.ema.europa.eu/en/medicines/human/EPAR/emgality).","questions":[{"text":"Which current local authorisation supports the proposed indication, population and product presentation?","id":"indication-and-presentation-q01","kind":"provenance"},{"text":"Does the proposed action fall within that authorisation, or require separate clinical justification?","id":"indication-and-presentation-q02","kind":"action"}]}]},{"id":"safety-evidence","name":"Safety evidence","description":"Separate treatment-related safety signals from occupational material hazards.","findings":[{"id":"clinical-safety-constraints","name":"Clinical safety constraints","description":"The June 2026 US label addresses serious hypersensitivity, constipation with serious complications, hypertension and Raynaud's phenomenon. Source: [US prescribing information](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=33a147be-233a-40e8-a55e-e40936e28db0).","questions":[{"text":"Which dated local safety statements require clinical review for the proposed use?","id":"clinical-safety-constraints-q01","kind":"action"},{"text":"What evidence distinguishes reactions to galcanezumab from reactions to excipients or administration?","id":"clinical-safety-constraints-q02","kind":"boundary"}]},{"id":"laboratory-handling-hazards","name":"Laboratory handling hazards","description":"Assess workplace precautions using documentation for the actual supplied material.","questions":[{"text":"Which supplier safety data sheet applies to this galcanezumab preparation?","id":"laboratory-handling-hazards-q01","kind":"provenance"},{"text":"Are hazard classifications and exposure limits established, absent or unassessed for that preparation?","id":"laboratory-handling-hazards-q02","kind":"definition"}]}]}]},{"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 galcanezumab 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 galcanezumab 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 galcanezumab 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 galcanezumab 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 galcanezumab 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 galcanezumab 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 galcanezumab 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 galcanezumab this model covers, and on what evidence?","id":"evidence-neighbours-q01","kind":"provenance"}]}]}]}]},"agentConduct":{"may":["Explain galcanezumab as an anti-CGRP antibody for migraine prevention, citing official labelling.","Report approved indications, injection guidance and warnings from the label."],"mustNot":["Recommend, dose or adjust galcanezumab for a specific person.","Advise using injectable biologics obtained from unverified sources.","Present it as a cure for migraine or as a treatment for acute attacks where not approved.","Advise storing or using it against the label's storage instructions."],"requiresHuman":["Starting, stopping or changing migraine treatment for a patient."]},"ethics":{"considerations":["Migraine is disabling and often dismissed; patients deserve accurate information.","High costs of biologics affect who can get treatment."],"affectedParties":["People with migraine or cluster headache","Prescribers and pharmacists","Employers and families"]},"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.galcanezumab","Wikidata: Q25326707 (https://www.wikidata.org/wiki/Q25326707)"]},"properties":{"applicability":"required","items":["Molecular identity reference: Versioned heavy-chain and light-chain sequence reference, with identity assay","Regulatory substance identity: INN, jurisdictional name and verified identifier records","CGRP binding: KD in mol/L, with ligand form, assay method and conditions","Functional neutralising potency: Relative potency against a named reference standard; assay-specific IC50 where applicable","Protein concentration: mg/mL, with sample matrix and analytical method","Monomer and aggregate content: Percent by a specified analytical method","Molecular variant profile: Assay-specific distributions of charge variants, glycans and chemical modifications","Material suitability: Unassessed, within documented specification, quarantined or rejected; tied to intended use","Storage exposure: Temperature in °C, duration in hours, freeze-thaw count and recorded light or agitation exposure","Authorised-product relationship: Product, jurisdiction, indication, population and label revision"]},"recognition":{"applicability":"required","items":["Identified by product label, active ingredient name and pack details rather than by appearance alone."]},"capabilities":{"applicability":"required","items":["Resolve galcanezumab names and identifiers against authoritative substance records.","Compare a sample's identity, purity and potency results with an applicable reference and specification.","Flag incomplete provenance or unsupported claims of clinical-grade suitability.","Evaluate documented storage excursions against formulation-specific stability evidence.","Retrieve the applicable product authorisation and safety information for a jurisdiction.","Route unresolved material-quality or clinical-use questions to the responsible specialist."]},"hazards":{"applicability":"required","items":["Injection-site reactions.","Allergic reactions.","Loss of potency if stored incorrectly."]},"interfaces":{"applicability":"required","items":["The Anatomical Therapeutic Chemical classification, maintained by the WHO Collaborating Centre for Drug Statistics Methodology, classifies galcanezumab among CGRP antagonists.","The Public Health Service Act, enacted by the United States Congress and administered for biological product licensing by the Food and Drug Administration, governs licensing of galcanezumab biological products in the United States."]},"context":{"applicability":"required","items":["Galcanezumab is encountered in injectable biological medicines used for migraine prevention and, in certain jurisdictions, episodic cluster headache treatment.","It also appears in pharmaceutical manufacturing, quality control and research concerning CGRP signaling.","Assessment of a supplied medicine depends on its authorized presentation, documented storage history and product-specific integrity requirements."]}},"sources":[{"title":"Wikidata item Q25326707: galcanezumab","url":"https://www.wikidata.org/wiki/Q25326707","note":"identity and sense of the item"},{"title":"Wikipedia: Galcanezumab","url":"https://en.wikipedia.org/wiki/Galcanezumab","note":"general description of the item"}],"openQuestions":["Which authoritative sequence reference and chemical identifier records should anchor this registry entry?","Which galcanezumab-specific potency assays, reference standards and batch acceptance limits are publicly documented?","What evidence defines acceptable molecular heterogeneity and degradation limits for bulk galcanezumab?","What preparation-specific stability and occupational hazard data exist beyond finished-product instructions, and which conventional physical constants are meaningful for this antibody?","What evidence gaps remain for pregnancy, lactation, paediatric use and long-term safety under the latest applicable regulatory reviews?"],"resources":{"spec":"/models/things/publications/thing-q25326707/spec.json"},"provenance":{"origin":"thing registry research (pass 2)","builtFrom":["models/things/publications/thing-q25326707/spec.json"],"providers":["Codex"],"researchStatus":"unreviewed","generatedAt":"2026-09-12T09:56:27Z","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}}