All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

piflufolastat F-18 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
enzyme inhibitors	5458	1207181-29-0

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: piflufolastat F-18 pylarify

Piflufolastat F 18 binds to cells that express PSMA (prostate-specific membrane antigen), including malignant prostate cancer cells, which usually overexpress PSMA. Fluorine-18 (F 18) is a β+ emitting radionuclide that enables positron emission tomography. Molecular weight: 441.40 Formula: C18H23FN4O8 CLOGP: -0.23 LIPINSKI: 2 HAC: 12 HDO: 6 TPSA: 195.02 ALOGS: -3.36 ROTB: 13 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
July 24, 2022	EMA	Curium Pet France
May 26, 2021	FDA	PROGENICS PHARMS INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Radioisotope scan abnormal	176.93	134.39	17	19	227	34956668

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Radioisotope scan abnormal	94.15	70.24	9	10	521	79743848

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
FDA MoA	N0000175869	Positron Emitting Activity
FDA EPC	N0000177914	Radioactive Diagnostic Agent

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Positron emission tomography	indication	82918005

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
50ML (1-80mCi/ML)	PYLARIFY	PROGENICS PHARMS INC	N214793	May 26, 2021	RX	SOLUTION	INTRAVENOUS	9861713	July 31, 2029	METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) IN MEN WITH PROSTATE CANCER
50ML (1-80mCi/ML)	PYLARIFY	PROGENICS PHARMS INC	N214793	May 26, 2021	RX	SOLUTION	INTRAVENOUS	8778305	Sept. 21, 2030	METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) IN MEN WITH PROSTATE CANCER
50ML (1-80mCi/ML)	PYLARIFY	PROGENICS PHARMS INC	N214793	May 26, 2021	RX	SOLUTION	INTRAVENOUS	10947197	June 9, 2037	METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) IN MEN WITH PROSTATE CANCER

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
50ML (1-80mCi/ML)	PYLARIFY	PROGENICS PHARMS INC	N214793	May 26, 2021	RX	SOLUTION	INTRAVENOUS	May 26, 2026	NEW CHEMICAL ENTITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Glutamate carboxypeptidase 2	Enzyme	Q04609	FOLH1_HUMAN	BINDING AGENT				UNKNOWN	DRUG LABEL

External reference:

ID	Source
3934EF02T7	UNII
C3492634	UMLSCUI
CHEMBL4297334	ChEMBL_ID
52950901	PUBCHEM_CID
DB14805	DRUGBANK_ID
11870	INN_ID
018744	NDDF
2556616	RXNORM
347074	MMSL
39555	MMSL
d09750	MMSL

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
PYLARIFY	HUMAN PRESCRIPTION DRUG LABEL	1	71258-022	INJECTION	80 mCi	INTRAVENOUS	NDA	27 sections
PYLARIFY	HUMAN PRESCRIPTION DRUG LABEL	1	71258-022	INJECTION	80 mCi	INTRAVENOUS	NDA	27 sections
PYLARIFY	HUMAN PRESCRIPTION DRUG LABEL	1	71258-022	INJECTION	80 mCi	INTRAVENOUS	NDA	27 sections