Flotufolastat (18F)

Flotufolastat (¹⁸
F)

Flotufolastat F-18 gallium
Clinical data
Trade names	Posluma
Other names	18F-rhPSMA-7.3, flotufolastat F18 (USAN US)
License data	US  DailyMed:  Flotufolastat f-18
Routes of administration	Intravenous
ATC code	V09IX18 ( WHO )
Legal status
Legal status	US: ℞-only [1]
Identifiers
CAS Number	2639294-14-5
PubChem CID	166177191
DrugBank	DB17851
ChemSpider	129955303
UNII	811W19E3OL
KEGG	D12606
ChEBI	CHEBI:229675
Chemical and physical data
Formula	C63H9918FN12O25Si
Molar mass	1537.3g·mol−1
3D model (JSmol)	Interactive image Interactive image
SMILES CC(C)(C)[Si]([18F])(C1=CC=C(C=C1)C(=O)NC[C@@H](NC(=O)CC[C@H](N1CCN(CC(O)=O)CCN(CC(O)=O)CCN(CC(O)=O)CC1)C(O)=O)C(=O)N[C@H](CCCCNC(=O)CCC(=O)NCCC[C@@H](NC(=O)CC[C@H](NC(=O)N[C@@H](CCC(O)=O)C(O)=O)C(O)=O)C(O)=O)C(O)=O)C(C)(C)C CC(C)(C)[Si](C1=CC=C(C=C1)C(=O)NC[C@H](C(=O)N[C@H](CCCCNC(=O)CCC(=O)NCCC[C@H](C(=O)O)NC(=O)CC[C@@H](C(=O)O)NC(=O)N[C@@H](CCC(=O)O)C(=O)O)C(=O)O)NC(=O)CC[C@@H](C(=O)O)N2CCN(CCN(CCN(CC2)CC(=O)[O-])CC(=O)[O-])CC(=O)[O-])(C(C)(C)C)[18F].[Ga+3]
InChI InChI=1S/C63H99FN12O25Si/c1-62(2,3)102(64,63(4,5)6)39-14-12-38(13-15-39)54(89)67-34-44(69-49(80)20-18-45(60(99)100)76-32-30-74(36-52(85)86)28-26-73(35-51(83)84)27-29-75(31-33-76)37-53(87)88)55(90)70-41(57(93)94)10-7-8-24-65-46(77)21-22-47(78)66-25-9-11-40(56(91)92)68-48(79)19-16-42(58(95)96)71-61(101)72-43(59(97)98)17-23-50(81)82/h12-15,40-45H,7-11,16-37H2,1-6H3,(H,65,77)(H,66,78)(H,67,89)(H,68,79)(H,69,80)(H,70,90)(H,81,82)(H,83,84)(H,85,86)(H,87,88)(H,91,92)(H,93,94)(H,95,96)(H,97,98)(H,99,100)(H2,71,72,101)/t40-,41-,42+,43+,44-,45+/m1/s1/i64-1 Key:QMGJNAVROCDAIW-MQNQVPOESA-N InChI=1S/C63H99FN12O25Si.Ga/c1-62(2,3)102(64,63(4,5)6)39-14-12-38(13-15-39)54(89)67-34-44(69-49(80)20-18-45(60(99)100)76-32-30-74(36-52(85)86)28-26-73(35-51(83)84)27-29-75(31-33-76)37-53(87)88)55(90)70-41(57(93)94)10-7-8-24-65-46(77)21-22-47(78)66-25-9-11-40(56(91)92)68-48(79)19-16-42(58(95)96)71-61(101)72-43(59(97)98)17-23-50(81)82;/h12-15,40-45H,7-11,16-37H2,1-6H3,(H,65,77)(H,66,78)(H,67,89)(H,68,79)(H,69,80)(H,70,90)(H,81,82)(H,83,84)(H,85,86)(H,87,88)(H,91,92)(H,93,94)(H,95,96)(H,97,98)(H,99,100)(H2,71,72,101);/q;+3/p-3/t40-,41-,42+,43+,44-,45+;/m1./s1/i64-1; Key:OJPQWJNFDOFXTN-WRFPGERRSA-K

Flotufolastat (¹⁸F), sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer. ^[1] The active ingredient is flotufolastat (¹⁸F). ^[1]

Flotufolastat (¹⁸F) was approved for medical use in the United States in May 2023. ^{[1] [2]}

Medical uses

Flotufolastat (¹⁸F) is indicated for positron emission tomography of prostate-specific membrane antigen positive lesions in men with prostate cancer. ^{[1] [3]}

References

1. "Posluma- flotufolastat f-18 injection". DailyMed. 2 June 2023. Retrieved 25 June 2023.
2. "U.S. FDA Approves Blue Earth Diagnostics' Posluma (Flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer" (Press release). Blue Earth Therapeutics. 30 May 2023. Retrieved 25 June 2023– via Business Wire.
3. Heo YA (September 2023). "Flotufolastat F 18: Diagnostic First Approval". Molecular Diagnosis & Therapy. 27 (5): 631–636. doi:10.1007/s40291-023-00665-y. PMID   37439946. S2CID   259843992.

External links

• Clinical trial number NCT04186819 for "Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer (LIGHTHOUSE)" at ClinicalTrials.gov
• Clinical trial number NCT04186845 for "Imaging Study to Investigate Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Suspected Prostate Cancer Recurrence (SPOTLIGHT)" at ClinicalTrials.gov