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68Ga-PSMA-11
68Ga-PSMA-11 is a PET imaging agent / radiopharmaceutical Small molecule drug developed by Weill Medical College of Cornell University. It is currently in Phase 3 development for PET imaging of PSMA-positive lesions in prostate cancer patients for staging and restaging. Also known as: 68Ga-PSMA-HBED-CC, 68Ga-PSMA-11 injection, Illucix, gallium Ga 68 Gozetotide.
68Ga-PSMA-11 is a positron emission tomography (PET) imaging agent that binds to prostate-specific membrane antigen (PSMA) on prostate cancer cells to enable visualization and detection.
68Ga-PSMA-11 is a small molecule diagnostic agent used for imaging. It is studied in conjunction with PET/MRI scans for evaluating and diagnosing conditions such as prostate cancer, malignant brain tumors, and suspected 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 | 68Ga-PSMA-11 |
|---|---|
| Also known as | 68Ga-PSMA-HBED-CC, 68Ga-PSMA-11 injection, Illucix, gallium Ga 68 Gozetotide, 68-gallium prostate-specific membrane antigen 11 positron emission tomography/magnetic resonance imaging |
| Sponsor | Weill Medical College of Cornell University |
| Drug class | PET imaging agent / radiopharmaceutical |
| Target | PSMA (prostate-specific membrane antigen) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
68Ga-PSMA-11 consists of gallium-68 (a positron-emitting radioisotope) conjugated to a small molecule ligand that targets PSMA, a transmembrane protein highly expressed on prostate cancer cells. When injected intravenously, the agent accumulates at sites of PSMA expression, allowing PET imaging to detect and localize prostate cancer lesions, including metastases. This enables improved staging, restaging, and treatment planning in prostate cancer patients.
Approved indications
- PET imaging of PSMA-positive lesions in prostate cancer patients for staging and restaging
Common side effects
Key clinical trials
- 177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (PHASE3)
- 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)
- Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan (PHASE2)
- Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial (PHASE2)
- 68Ga-PSMA PET in the Renal Cell Carcinoma (NA)
- NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (PHASE1)
- An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) (PHASE3)
- Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT) (PHASE2)
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:
- 68Ga-PSMA-11 CI brief — competitive landscape report
- 68Ga-PSMA-11 updates RSS · CI watch RSS
- Weill Medical College of Cornell University portfolio CI
Frequently asked questions about 68Ga-PSMA-11
What is 68Ga-PSMA-11?
How does 68Ga-PSMA-11 work?
What is 68Ga-PSMA-11 used for?
Who makes 68Ga-PSMA-11?
Is 68Ga-PSMA-11 also known as anything else?
What drug class is 68Ga-PSMA-11 in?
What development phase is 68Ga-PSMA-11 in?
What does 68Ga-PSMA-11 target?
Related
- Drug class: All PET imaging agent / radiopharmaceutical drugs
- Target: All drugs targeting PSMA (prostate-specific membrane antigen)
- Manufacturer: Weill Medical College of Cornell University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for PET imaging of PSMA-positive lesions in prostate cancer patients for staging and restaging
- Also known as: 68Ga-PSMA-HBED-CC, 68Ga-PSMA-11 injection, Illucix, gallium Ga 68 Gozetotide, 68-gallium prostate-specific membrane antigen 11 positron emission tomography/magnetic resonance imaging
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing