Posluma

(Flotufolastat F-18 Gallium)

Phase 2Radiopharmaceutical

Posluma is one of 38 small molecule programs targeting Biochemically Recurrent Prostate Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Biochemically Recurrent Prostate CarcinomaRecruiting

Prostate CarcinomaRecruiting

Biochemically Recurrent Prostate CarcinomaPhase 1

Recruiting

Prostate CarcinomaPhase 2

Recruiting

Competition

Competitive Landscape

39 competitors in Prostate Carcinoma

#DrugCompanyPhaseTrials

Erleada

Johnson & Johnson

Approved

2 2

Nubeqa

Bayer

Approved

1 3

Xtandi

Astellas

Approved

—4

Lupron

Sun Pharmaceutical Industries, Inc.

Lynparza

Estrace

Balversa

Jevtana

Farxiga

Ritalin

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2029

Phase 2Recruiting

Prostate Carcinoma

NCT06865768

Q1 2032

Phase 1Recruiting

Biochemically Recurrent Prostate Carcinoma

NCT06813898

Clinical

Trials by Indication[1]

Prostate Carcinoma1 trial

Prospective Phase II Validation of the Performance of a Prostate-Specific Membrane Antigen (PSMA) Radiotracer for Positron Emission Tomography-Multiparametric Magnetic Resonance (PET-mpMR) Imaging to Target Prostate Biopsy Via Transrectal Ultrasound (TRUS) -Magnetic Resonance Imaging (MRI) Fusion Technique

Recruiting·EEmory University·Phase 2·NCT06865768·90 enrolled

Biochemically Recurrent Prostate Carcinoma1 trial

ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging

Recruiting·NNorthwestern University·Phase 1·NCT06813898·27 enrolled

Regulatory

FDA Approval Timeline[4]

May 25, 2023

POSLUMA

NDA NDA216023

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Flotufolastat F-18 Gallium. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Flotufolastat F-18 Gallium compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Flotufolastat F-18 Gallium. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216023). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Posluma. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Blue Earth Diagnostics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Radiopharmaceutical[2]
Highest Phase: Phase 2[1]
Company: BBlue Earth Diagnostics

Patent Landscape[5]

Patent Cliff

Aug 23, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12390540Aug 23, 2038

11413360Nov 22, 2038

12357711Nov 22, 2038

12377176Nov 22, 2038

12036290Nov 27, 2041

1 more patents

12427207Nov 27, 2041

Posluma

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2029

Q1 2032

Trials by Indication[1]

Prostate Carcinoma1 trial

Biochemically Recurrent Prostate Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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