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Ga-PSMA-11
Ga-PSMA-11 is a Radiopharmaceutical; PET imaging agent Small molecule drug developed by University of Colorado, Denver. It is currently in Phase 3 development for PET imaging of PSMA-positive lesions in men with prostate cancer, Staging and restaging of prostate cancer.
Ga-PSMA-11 is a gallium-68 labeled imaging agent that binds to prostate-specific membrane antigen (PSMA) on prostate cancer cells to enable PET imaging detection.
Ga-PSMA-11 is a gallium-68 labeled imaging agent that binds to prostate-specific membrane antigen (PSMA) on prostate cancer cells to enable PET imaging detection. Used for PET imaging of PSMA-positive lesions in men with prostate cancer, Staging and restaging of prostate cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Ga-PSMA-11 |
|---|---|
| Sponsor | University of Colorado, Denver |
| Drug class | Radiopharmaceutical; PET imaging agent |
| Target | PSMA (prostate-specific membrane antigen) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Ga-PSMA-11 consists of gallium-68, a positron-emitting radioisotope, conjugated to a small molecule ligand that specifically targets PSMA, a transmembrane protein highly expressed on prostate cancer cells. When injected intravenously, it accumulates at sites of PSMA expression and emits positrons that are detected by PET imaging, allowing visualization and localization of prostate cancer lesions. This enables improved staging, restaging, and monitoring of prostate cancer patients.
Approved indications
- PET imaging of PSMA-positive lesions in men with prostate cancer
- Staging and restaging of prostate cancer
Common side effects
- Injection site reactions
- Radiation exposure (expected from PET imaging)
Key clinical trials
- A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (PHASE2)
- Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (PHASE2)
- NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (PHASE1)
- Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT) (PHASE2)
- PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN)
- A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC (PHASE2)
- Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy (EARLY_PHASE1)
- Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ga-PSMA-11 CI brief — competitive landscape report
- Ga-PSMA-11 updates RSS · CI watch RSS
- University of Colorado, Denver portfolio CI
Frequently asked questions about Ga-PSMA-11
What is Ga-PSMA-11?
How does Ga-PSMA-11 work?
What is Ga-PSMA-11 used for?
Who makes Ga-PSMA-11?
What drug class is Ga-PSMA-11 in?
What development phase is Ga-PSMA-11 in?
What are the side effects of Ga-PSMA-11?
What does Ga-PSMA-11 target?
Related
- Drug class: All Radiopharmaceutical; PET imaging agent drugs
- Target: All drugs targeting PSMA (prostate-specific membrane antigen)
- Manufacturer: University of Colorado, Denver — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for PET imaging of PSMA-positive lesions in men with prostate cancer
- Indication: Drugs for Staging and restaging of prostate cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing