Flurpiridaz (18F)

Flurpiridaz (18F)
Clinical data
Trade names	Flyrcado
Other names	NMB58, BMS-747158-02, flurpiridaz F-18, flurpiridaz F 18 (USAN US)
AHFS/Drugs.com	Flyrcado
License data	US DailyMed: Flurpiridaz;
Routes of; administration	Intravenous
ATC code	None;
Legal status
Legal status	US: ℞-only;
Identifiers
	IUPAC name 2-tert-butyl-4-chloro-5-({4-[(2- [18F]fluoroethoxy)methyl]phenyl}methoxy)pyridazin-3(2H)-one;
CAS Number	863887-89-2;
PubChem CID	11405965;
DrugBank	DB18773;
ChemSpider	9580860;
UNII	TY3V24C029;
KEGG	D10009;
CompTox Dashboard (EPA)	DTXSID00235517 ;
Chemical and physical data
Formula	C18H22Cl[18F]N2O3
Molar mass	367.8
3D model (JSmol)	Interactive image;
	SMILES CC(C)(C)N1N=CC(OCC2=CC=C(COCC[18F])C=C2)=C(Cl)C1=O;
	InChI InChI=1S/C18H22ClFN2O3/c1-18(2,3)22-17(23)16(19)15(10-21-22)25-12-14-6-4-13(5-7-14)11-24-9-8-20/h4-7,10H,8-9,11-12H2,1-3H3/i20-1; Key:RMXZKEPDYBTFOS-LRFGSCOBSA-N;

Flurpiridaz (¹⁸F), sold under the brand name Flyrcado, is a cyclotron-produced radioactive diagnostic agent for use with positron emission tomography (PET) myocardial perfusion imaging under rest or stress (pharmacologic or exercise).^[3] Flurpiridaz (¹⁸F) It is given by intravenous injection.^[3]

The most common adverse reactions include dyspnea (shortness of breath), headache, angina pectoris (severe pain in the chest), chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia (irregular heartbeat).^[3]

Flurpiridaz (¹⁸F) was approved by the FDA for medical use evaluate for myocardial ischemia and infarction in the United States in September 2024.^[3]^[4]^[5]

Medical uses

Flurpiridaz (¹⁸F) is indicated for positron emission tomography myocardial perfusion imaging under rest or stress (pharmacologic or exercise) in adults with known or suspected coronary artery disease to evaluate for myocardial ischemia and infarction.^[2]^[3]

History

Flurpiridaz F-18 is a fluorine 18-labeled agent developed by Lantheus Medical Imaging for the diagnosis of coronary artery disease.^[6]

The efficacy and safety of flurpiridaz (¹⁸F) were evaluated in two prospective, multicenter, open-label clinical studies in adults with either suspected CAD (Study 1: NCT03354273) or known or suspected CAD (Study 2: NCT01347710).^[3] Study 1 evaluated the sensitivity (ability to designate an imaged patient with disease as positive) and specificity (ability to designate an imaged patient without disease as negative) of flurpiridaz (¹⁸F) for the detection of significant CAD in subjects with suspected CAD who were scheduled for invasive coronary angiography (ICA).^[3] Across three flurpiridaz (¹⁸F) imaging readers, estimates of sensitivity ranged from 74% to 89% and estimates of specificity ranged from 53% to 70% for CAD defined as at least 50% narrowing of an artery.^[3]

Study 2 evaluated the sensitivity and specificity of flurpiridaz (¹⁸F) for the detection of significant CAD in subjects with known or suspected CAD who had ICA without intervention within 60 days prior to imaging or were scheduled for ICA.^[3] Across three flurpiridaz (¹⁸F) imaging readers, estimates of sensitivity ranged from 63% to 77% and estimates of specificity ranged from 66% to 86% for CAD defined as at least 50% narrowing of an artery.^[3]

Society and culture

Legal status

Flurpiridaz (¹⁸F) was approved for medical use in the United States in September 2024.^[2]^[3]^[4]

Names

Flurpiridaz (¹⁸F) is the international nonproprietary name.^[7]

References

^ "Flurpiridaz F 18". AMA Finder. Retrieved 27 September 2024.
^ ^a ^b ^c ^d ^e "Flyrcado (flurpiridaz F 18) injection, for intravenous use" (PDF). U.S. Food and Drug Administration (FDA). Retrieved 27 September 2024.
^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ ^j ^k "FDA approves imaging drug for evaluation of myocardial ischemia". U.S. Food and Drug Administration. 27 September 2024. Retrieved 27 September 2024. This article incorporates text from this source, which is in the public domain.
^ ^a ^b "Flyrcado: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 27 September 2024.
^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration. 1 October 2024. Retrieved 8 November 2024.
^ "Flurpiridaz F-18". Inxight Drugs. Retrieved 27 September 2024.
^ World Health Organization (2011). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 65". WHO Drug Information. 25 (1). hdl:10665/74623.

External links

Clinical trial number NCT03354273 for "An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)" at ClinicalTrials.gov
Clinical trial number NCT01347710 for "A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD" at ClinicalTrials.gov

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[1] "Flurpiridaz F 18". AMA Finder. Retrieved 27 September 2024.

[Flyrcado_FDA_label-2] "Flyrcado (flurpiridaz F 18) injection, for intravenous use" (PDF). U.S. Food and Drug Administration (FDA). Retrieved 27 September 2024.

[FDA_Flyrcado-3] ^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ ^j ^k "FDA approves imaging drug for evaluation of myocardial ischemia". U.S. Food and Drug Administration. 27 September 2024. Retrieved 27 September 2024. This article incorporates text from this source, which is in the public domain.

[Drugs@FDA-4] "Flyrcado: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 27 September 2024.

[5] "Novel Drug Approvals for 2024". U.S. Food and Drug Administration. 1 October 2024. Retrieved 8 November 2024.

[6] "Flurpiridaz F-18". Inxight Drugs. Retrieved 27 September 2024.

[7] World Health Organization (2011). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 65". WHO Drug Information. 25 (1). hdl:10665/74623.

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