Drugs / Ga-PSMA-11
Ga-PSMA-11
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05197257 | Sep 2021 → Apr 2022 | prostate adenocarcinoma | University of Colorado, Denver | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-09-19 | Eckert & Ziegler Radiopharma GmbH | Regulatory Eckert & Ziegler Gains Approval for GalliaPharm® in Japan ezag.com ↗
This authorization opens the door for broader use of Gallium-68–based diagnostics in Japan through the clinical use of the Novartis kit Locametz® for radiopharmaceutical preparation of 68 Ga-PSMA-11, which has also been granted approval. |
| 2023-03-16 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory FDA Approves Expanded Indication for Telix’s Illuccix® to Include Patient Selection for PSMA-Directed Radioligand Therapy telixpharma.com ↗ |
| 2021-11-12 | Eckert & Ziegler Radiopharma GmbH | Regulatory Eckert & Ziegler Announces Clinical Trial Notification for Joint Clinical Trial in Japan ezag.com ↗
Eckert & Ziegler (ISIN DE0005659700, TecDAX) announced that the Clinical Trial Notification (CTN) of a joint clinical study with Novartis Pharma K.K. (Japan) was accepted by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for 68 Ga-PSMA-11, an investigational radioligand imaging agent and 177 Lu-PSMA-617, an investigational radioligand therapy in metastatic prostate cancer. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-09-19 | Eckert & Ziegler Radiopharma GmbH | Eckert & Ziegler Gains Approval for GalliaPharm® in Japan ezag.com ↗ |
| 2023-03-16 | Telix Pharmaceuticals (Innovations) Pty Limited | FDA Approves Expanded Indication for Telix’s Illuccix® to Include Patient Selection for PSMA-Directed Radioligand Therapy telixpharma.com ↗ |
| 2021-11-12 | Eckert & Ziegler Radiopharma GmbH | Eckert & Ziegler Announces Clinical Trial Notification for Joint Clinical Trial in Japan ezag.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ga-PSMA-11 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05197257 ↗ |
| Known as | 68Ga-PSMA-11 | “The intervention is a PET scan with the radiolabelled Prostate-specific membrane antifen (PSMA) ligand, 68Ga-PSMA-11.” NCT05197257 ↗ |
| Known as | Ga-68 PSMA-11 | “AEs will be collected during injection and uptake phase (45-120 min posts infusion) of Ga-68 PSMA-11 PET/CT scan.” NCT05197257 ↗ |
| Modality | Diagnostic / imaging agent | “The intervention is a PET scan with the radiolabelled Prostate-specific membrane antifen (PSMA) ligand” NCT05197257 ↗ |
| Route | Intravenous | “One intravenous catheter will be placed for radiopharmaceutical administration.” NCT05197257 ↗ |