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PIFLUFOLASTAT — Competitive Intelligence Brief

PIFLUFOLASTAT (PIFLUFOLASTAT) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Radioactive Diagnostic Agent [EPC].

marketed Radioactive Diagnostic Agent [EPC] PSMA Small molecule Live · refreshed every 30 min

Target snapshot

PIFLUFOLASTAT (PIFLUFOLASTAT). Piflufolastat F 18 binds to PSMA-expressing cells, including prostate cancer cells, and emits positrons for imaging.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
PIFLUFOLASTAT TARGET PIFLUFOLASTAT marketed Radioactive Diagnostic Agent [EPC] PSMA 2021-01-01
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN marketed Radioligand Therapeutic Agent [EPC] PSMA 2022-01-01
[Ga-68]PSMA [Ga-68]PSMA Norbert Avril, M.D. marketed PET imaging agent / radiopharmaceutical PSMA (prostate-specific membrane antigen)
18F-rhPSMA-7.3 18F-rhPSMA-7.3 Hackensack Meridian Health marketed PET imaging agent / radiopharmaceutical PSMA (prostate-specific membrane antigen)
piflufolastat (18F) piflufolastat (18F) Blue Earth Diagnostics marketed PSMA-targeting PET imaging agent PSMA (prostate-specific membrane antigen)
64Cu-SAR-bisPSMA 64Cu-SAR-bisPSMA Clarity Pharmaceuticals Ltd phase 3 Radiopharmaceutical; PET imaging agent PSMA (prostate-specific membrane antigen)
68Ga-PSMA-11 68Ga-PSMA-11 Weill Medical College of Cornell University phase 3 PET imaging agent / radiopharmaceutical PSMA (prostate-specific membrane antigen)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Radioactive Diagnostic Agent [EPC] class)

  1. · 6 drugs in this class
  2. GE HealthCare · 3 drugs in this class
  3. Blue Earth · 2 drugs in this class
  4. Avid Radiopharms Inc · 2 drugs in this class
  5. Ge Hlthcare Inc · 2 drugs in this class
  6. Ge Healthcare · 1 drug in this class
  7. Ge Hlthcare · 1 drug in this class
  8. Lantheus Medical Imaging · 1 drug in this class
  9. Life Molecular · 1 drug in this class
  10. Mcprf · 1 drug in this class

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Cite this brief

Drug Landscape (2026). PIFLUFOLASTAT — Competitive Intelligence Brief. https://druglandscape.com/ci/piflufolastat. Accessed 2026-05-14.

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