Drugs / 68Ga-PSMA-11
68Ga-PSMA-11
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ILLUCCIX | — | 2023-03-15 | fda.gov ↗ |
| Approved | US (FDA) | GALLIUM GA 68 GOZETOTIDE | — | 2020-12-01 | fda.gov ↗ |
Trials 47
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 08 trials | ||||||
| Phase 0 | NCT07674771 | Jul 2026 → Jun 2029 expected | castration-resistant prostate carcinoma | University of Texas Southwestern Medical Center | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06437496 | Apr → Jul 2024 | prostate cancer | First Affiliated Hospital of Fujian Medical University | Unknown | No outcome recorded |
| Phase 0 | NCT05558956 | Nov 2022 → Dec 2023 | castration-resistant prostate carcinoma | BAMF Health | Unknown | No outcome recorded |
| Phase 0 | NCT04831541 | Oct 2020 → Dec 2024 | prostate cancer | First Affiliated Hospital of Fujian Medical University | Unknown | No outcome recorded |
| Phase 0 | NCT04310540 | Jun 2020 → Nov 2023 | hepatocellular carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 0 | NCT03982407 | Jun 2019 → May 2021 | hepatocellular carcinoma | Ajit H. Goenka, MD | Completed | No outcome recorded |
| Phase 0 | NCT03768349 | Jan 2019 → Jul 2021 | prostate cancer | Mayo Clinic | Completed | No outcome recorded |
| Phase 0 | NCT02952469 | Jul 2016 → Apr 2022 | prostate cancer | University of Iowa | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT04750473 | Jul 2021 → Mar 2023 | female breast carcinoma, invasive lobular breast carcinoma | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT04279561 | Apr 2020 → Sep 2022 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Jonsson Comprehensive Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03822871 | Apr 2019 → Oct 2022 | prostate cancer | Cancer Targeted Technology | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT07117760 | Apr 2025 → Dec 2027 expected | prostate cancer | First Affiliated Hospital of Fujian Medical University | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05627778 | Nov 2021 → Dec 2022 | metastatic prostate carcinoma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT03949517 | Apr 2019 → Mar 2022 | prostate cancer | Andrei Iagaru | Completed | No outcome recorded |
| Phase 1/2 | NCT03545165 | Apr 2018 → Jul 2020 | prostate cancer | Weill Medical College of Cornell University | Terminated | No outcome recorded |
| Phase 1/2 | NCT03362359 | Oct 2017 → Jul 2020 | metastatic malignant neoplasm in the lymph nodes, metastatic prostate carcinoma | German Cancer Research Center | Completed | No outcome recorded |
| Phase 212 trials · 1 met primary | ||||||
| Phase 2 | NCT06444412 | Jan 2026 → Jul 2028 expected | grade III glioma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT06521775 | Aug 2024 → Aug 2025 | adenoid cystic carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT05670106 | May 2023 → May 2024 | prostate carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT05176223 | Jan 2022 → Dec 2025 | hepatocellular carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT04716725 | Sep 2021 → Sep 2023 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Thomas Hope | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04777071 | May 2021 → Jul 2025 overdue | prostate adenocarcinoma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04483414 | Mar 2021 → Apr 2023 | metastatic carcinoma in the bone, metastatic prostate carcinoma | Dana Mathews | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04762888 | Feb 2021 → Jun 2025 | hepatocellular carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT04264208 | Feb 2020 → Nov 2022 | prostate cancer | Andrei Iagaru | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04179968 | Jan 2020 → Sep 2021 | metastatic prostate carcinoma | Dana Mathews | Completed | No outcome recorded |
| Phase 2 | NCT03809078 | Jan 2019 → Mar 2022 | prostate cancer | Andrei Iagaru | Completed | No outcome recorded |
| Phase 2 | NCT03439033 | Apr 2018 → May 2021 | prostate cancer | Weill Medical College of Cornell University | Terminated | Met primary |
| Phase 2/35 trials | ||||||
| Phase 2/3 | NCT07209878 | Jan 2020 → Dec 2025 overdue | prostate adenocarcinoma | First Affiliated Hospital of Fujian Medical University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT02673151 | May 2017 → Apr 2018 | prostate adenocarcinoma | Andrei Iagaru | Completed | No outcome recorded |
| Phase 2/3 | NCT02919111 | Sep 2016 → Dec 2019 | prostate cancer | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2/3 | NCT02918357 | Sep 2016 → Sep 2017 | prostate cancer | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2/3 | NCT02678351 | Apr 2016 → Dec 2020 | prostate adenocarcinoma | Andrei Iagaru | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT07052214 | Aug 2025 → Jun 2026 overdue | prostate carcinoma | Telix Pharmaceuticals (Innovations) Pty Limited | Recruiting | No outcome recorded |
| Phase 3 | NCT05847348 | Jul 2023 → Dec 2025 overdue | prostate carcinoma | Telix Pharmaceuticals (Innovations) Pty Limited | Recruiting | No outcome recorded |
| Phase 3 | NCT05744115 | Jul 2021 → Apr 2022 | prostate adenocarcinoma | Timothy Hoffman | Terminated | No outcome recorded |
| Phase 3 | NCT04684628 | Dec 2020 → Jan 2025 | prostate cancer | University of Saskatchewan | Suspended | No outcome recorded |
| Phase 3 | NCT03623425 | Feb 2019 → May 2020 | prostate cancer | Central Hospital, Nancy, France | Unknown | No outcome recorded |
| Phase 3 | NCT03803475 | Oct 2018 → Aug 2020 | prostate cancer | Thomas Hope | Completed | No outcome recorded |
| Phase 3 | NCT03353740 | Sep 2017 → Sep 2020 | prostate cancer | Thomas Hope | Completed | No outcome recorded |
| Phase 3 | NCT02659527 | Jan 2016 → May 2022 | prostate cancer | Medical University of Vienna | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05324332 | Apr 2022 → Jan 2025 overdue | prostate cancer | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| — | NCT03187990 | Mar 2017 → Aug 2021 | prostate cancer | Irene Burger | Completed | No outcome recorded |
| Phase not stated4 trials | ||||||
| — | NCT04452136 | — | prostate cancer | Jeanne Link | Approved for marketing | No outcome recorded |
| — | NCT05415228 | — | prostate adenocarcinoma | Morand Piert, MD | No longer available | No outcome recorded |
| — | NCT05002465 | — | metastatic prostate carcinoma | Dana Mathews | No longer available | No outcome recorded |
| — | NCT04854369 | — | castration-resistant prostate carcinoma | Tulane University | No longer available | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT04886986 Background | Jun 2021 → Dec 2027 expected | prostate cancer | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06881823 Comparator | Jun 2026 → Mar 2030 | prostate cancer | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT03675451 Background | Feb 2017 → Jun 2018 | prostate cancer | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 3 | NCT05939414 Background | Mar 2024 → Apr 2028 expected | metastatic prostate carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05547386 Background | May 2022 → Dec 2023 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Mayo Clinic | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 47
| Date | Issuer | Release |
|---|---|---|
| 2026-09-29 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Granted FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Cancer Imaging telixpharma.com ↗
FDA Fast Track designation granted for Telix’s BiPASS® program, which is evaluating 68Ga-PSMA-PET imaging alongside MRI in the pre-biopsy prostate cancer setting. |
| 2026-07-22 | Telix Pharmaceuticals (Innovations) Pty Limited | Results TLX591-Tx ProstACT SELECT Study Published in Cancers Journal telixpharma.com ↗
Peer-reviewed publication of ProstACT SELECT[1] results confirm the utility of 68Ga (gallium)-PSMA-PET imaging to select patients for TLX591-Tx therapy using a theranostic approach[2]. |
| 2026-06-10 | Radiomedix, Inc. | Regulatory RadioMedix Announces Receiving FDA Approval of its Generic Ga-68 PSMA-11 Radiodiagnostic for Prostate Cancer radiomedix.com ↗
FDA approval of our Ga68 PSMA-11 Abbreviated New Drug Application (ANDA) represents an important milestone for RadioMedix and reinforces our commitment to expanding availability of cost effective and high-quality radiopharmaceuticals for patients, |
| 2026-04-07 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Q1 2026: Strong Revenue Growth and Therapeutics Pipeline Advancement telixpharma.com ↗
TLX591-Px[5]: NDA accepted in China by the National Medical Products Administration (NMPA)[6]. |
| 2026-01-19 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Chinese NMPA Accepts New Drug Application for Illuccix for Prostate Cancer Imaging telixpharma.com ↗
Telix today announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted the filing of a New Drug Application (NDA) for TLX591-Px (Illuccix®, Kit for the preparation of 68Ga-PSMA-11), Telix’s lead prostate cancer imaging agent. |
| 2025-12-21 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions telixpharma.com ↗
Telix is pleased to announce positive top-line results from its Phase 3 registration study of TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging in Chinese patients. |
| 2025-08-29 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix’s Illuccix® PSMA-PET Imaging Agent Approved in Spain telixpharma.com ↗
Illuccix® is now approved in all 19 countries included in Telix’s decentralized procedure (DCP) submitted in Europe. |
| 2025-07-18 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Prostate Cancer PSMA-PET Imaging Agent Approved in Austria telixpharma.com ↗
Illuccix, after radiolabelling with gallium-68, is indicated in Austria for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: |
| 2025-06-24 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix’s Illuccix® PSMA-PET Imaging Agent Approved in Italy telixpharma.com ↗
Telix today announces that its prostate cancer PET[1] imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in Italy by the AIFA[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. |
| 2025-06-23 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Prostate Cancer PSMA-PET Imaging Agent Approved in Belgium telixpharma.com ↗
This approval enables healthcare providers in Belgium to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical. |
| 2025-06-13 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Prostate Cancer PSMA-PET Imaging Agent Approved in Greece telixpharma.com ↗
This approval enhances the options available to healthcare providers across Greece for PSMA-PET[3] imaging using a clinically-validated, gallium-based radiopharmaceutical. |
| 2025-06-05 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix’s Illuccix® PSMA-PET Imaging Agent Approved in Germany telixpharma.com ↗
Telix’s Illuccix® PSMA-PET Imaging Agent Approved in Germany |
| 2025-06-04 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix’s Illuccix® PSMA-PET Imaging Agent Approved in Portugal telixpharma.com ↗
This approval enhances the options available to healthcare providers across Portugal for PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical. |
| 2025-05-05 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix’s Illuccix® PSMA-PET Imaging Agent Approved in the Czech Republic telixpharma.com ↗
New approval provides hospitals and clinics in the Czech Republic with access to a proven PSMA-PET imaging agent |
| 2025-04-30 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix Prostate Cancer PSMA-PET Imaging Agent Approved in Finland telixpharma.com ↗
Telix today announces that its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by Fimea[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. |
| 2025-04-28 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix’s Illuccix PSMA-PET Imaging Agent Approved in France telixpharma.com ↗
Telix’s Illuccix PSMA-PET Imaging Agent Approved in France |
| 2025-04-15 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Prostate Cancer PSMA-PET Imaging Agent Approved in Sweden telixpharma.com ↗
This approval enables healthcare providers in Sweden to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical. |
| 2025-03-20 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory FDA Approves New Prostate Cancer Imaging Agent Gozellix® telixpharma.com ↗
Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET imaging[1] agent for prostate cancer. |
| 2025-03-18 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Prostate Cancer PSMA-PET Imaging Agent Approved in The Netherlands telixpharma.com ↗
Telix today announces that its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by MEB[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. |
| 2025-03-17 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Approved for Prostate Cancer Imaging in Brazil: First Marketing Authorization in Latin America telixpharma.com ↗
Telix today announces that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ‘ANVISA’) has approved Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) the Company’s lead prostate cancer imaging agent. |
| 2025-02-25 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Prostate Cancer Imaging Agent Approved in Malta telixpharma.com ↗
This approval enables healthcare providers in Malta to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical. |
| 2025-02-25 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Prostate Cancer Imaging Agent Approved in Luxembourg telixpharma.com ↗
This approval enables healthcare providers in Luxembourg to offer PSMA-PET[3] imaging using a clinically validated gallium-based radiopharmaceutical. |
| 2025-02-24 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Approved in Norway telixpharma.com ↗
Telix today announces that its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by NOMA[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. |
| 2025-02-12 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Approved in the United Kingdom telixpharma.com ↗
Telix today announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application (MAA) for its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection). |
| 2025-02-11 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Approved in Denmark telixpharma.com ↗
Telix today announces that its prostate cancer PET[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been approved by the Danish Medicines Agency (Lægemiddelstyrelsen). |
| 2025-01-16 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Receives European Approval telixpharma.com ↗
Through the DCP, the RMS and all 18 European Economic Area (EEA) Concerned Member States (CMS)[3] agree that Illuccix should receive marketing authorization. |
| 2024-10-07 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Australian TGA Approves Additional Indication for Telix’s Illuccix® to Include Patient Selection for PSMA-Targeted Therapy telixpharma.com ↗
Telix today announces that the Australian Therapeutic Goods Administration (TGA) has approved the use of Illuccix® (kit for the preparation of 68Ga-PSMA-11[1] injection) to select patients for PSMA[2]-targeted radionuclide therapy. |
| 2024-10-04 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Health Canada Approves Label Expansion for Telix’s Illuccix® to Include Patient Selection for PSMA-Targeted Therapy telixpharma.com ↗
Telix today announces that Health Canada has approved the use of Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) in selecting patients for PSMA[1]-targeted radionuclide therapy. |
| 2024-07-23 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory FDA Accepts Telix NDA for New Prostate Cancer Imaging Agent telixpharma.com ↗ |
| 2023-10-18 | Telix Pharmaceuticals (Innovations) Pty Limited | Results ProstACT SELECT Study of TLX591 Interim Readout: Positive Results Confirm Safety and Tolerability telixpharma.com ↗
Consistent lesion delineation between TLX591 and 68Ga-PSMA-11 imaging, within the detection sensitivity and resolution limits of SPECT |
| 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 ↗
Telix Pharmaceuticals today announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) to enable its use for the selection of patients with metastatic prostate cancer, for whom 177Lu 177 PSMA-directed therapy is indicated. |
| 2022-10-16 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Chinese NMPA Approves Pivotal Phase III Study of TLX591-CDx for Prostate Cancer Imaging telixpharma.com ↗
Chinese NMPA Approves Pivotal Phase III Study of TLX591-CDx for Prostate Cancer Imaging |
| 2022-10-14 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Health Canada Approves Illuccix® for Prostate Cancer Imaging telixpharma.com ↗
Telix announces that Health Canada has approved Illuccix® [kit for the preparation of gallium (68Ga) gozetotide injection] for use in staging and re-staging intermediate and high-risk prostate cancer and localizing tumour tissue in recurrent prostate cancer. |
| 2022-03-23 | Novartis Pharmaceuticals | Regulatory Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer novartis.com ↗
FDA also approved complementary diagnostic imaging agent, Locametz ® , after radiolabeling with gallium-68 for the identification of PSMA-positive lesions |
| 2022-02-08 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Japanese Prostate Cancer Imaging Trial Meets Study Objectives telixpharma.com ↗
The study has met its objectives, demonstrating safety and tolerability when using TLX591-CDx (Kit for the preparation of gallium-68 (68Ga) PSMA-11 injection). |
| 2021-12-20 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory FDA Approves Telix’s Prostate Cancer Imaging Product, Illuccix® telixpharma.com ↗
Telix is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Illuccix® (TLX591-CDx), Telix’s lead prostate cancer imaging product. |
| 2021-12-01 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Illuccix® Granted Use Authorisation for Prostate Cancer Imaging in Brazil telixpharma.com ↗
The exceptional authorisation grants permission to commence selling Illuccix in Brazil, ahead of a full regulatory approval, expected next year. |
| 2021-11-02 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Australian TGA Approves Illuccix® for Prostate Cancer Imaging telixpharma.com ↗
Australian Therapeutic Goods Administration has approved Illuccix® for the diagnostic imaging of men with prostate cancer. |
| 2021-06-17 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Update on FDA New Drug Application Review for Illuccix® telixpharma.com ↗
During the meeting, the FDA indicated that there are no outstanding substantive review issues with Telix’s submission. |
| 2021-04-14 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Australian TGA Accepts Telix’s Prostate Cancer Imaging Product Submission and Commences Priority Evaluation Process telixpharma.com ↗
Telix announces the Australian Therapeutic Goods Administration has accepted its prostate cancer imaging product submission and commenced the priority evaluation process |
| 2021-02-22 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix and Kanazawa University Cleared to Commence Prostate Cancer Imaging Study in Japan telixpharma.com ↗
Telix Japan receives Clinical Trial Notification (CTN) clearance to commence a Phase I trial of its prostate cancer imaging product in Japan. |
| 2021-02-16 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Czech Republic Grants National Authorisation for the Use of Telix’s Prostate Cancer Imaging Product telixpharma.com ↗
Telix announces the Ministry of Health of the Czech Republic is the first European health authority to grant a national authorization allowing the use of TLX591-CDx |
| 2020-12-16 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Pharmaceuticals Files New Drug Submission with Health Canada for Prostate Cancer Imaging Product telixpharma.com ↗
Telix has filed a New Drug Submission (NDS) with Health Canada for TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11). |
| 2020-12-07 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Granted TGA Priority Review for Prostate Cancer Imaging telixpharma.com ↗
Telix has been granted Priority Review status for TLX591-CDx (68Ga-PSMA-11), a radiopharmaceutical for the imaging of prostate cancer using Positron Emission Tomography (PET). |
| 2020-11-24 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix New Drug Application for Prostate Cancer Imaging Product Accepted by US FDA telixpharma.com ↗
We are delighted to have achieved this significant milestone with the FDA’s acceptance for filing of the first commercial NDA for PSMA imaging in the United States. |
| 2020-09-24 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Pharmaceuticals Submits New Drug Application to US FDA for Prostate Cancer Imaging Product telixpharma.com ↗
Telix Pharmaceuticals submits NDA to US FDA for TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11) |
| 2020-05-01 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Submits European Marketing Authorisation Application for Prostate Cancer Imaging Product telixpharma.com ↗
Telix Pharmaceuticals Limited is pleased to announce that it has submitted a marketing authorisation application (MAA) in Europe for TLX591-CDx (68Ga-PSMA-11 Injection) for the imaging of prostate cancer with Positron Emission Tomography (PET). |
All press releases naming this drug 69 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 53 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 68Ga-PSMA-11 | “Administration of 68Ga-PSMA-11 followed by a PET/CT scan at 45 min after injection.” NCT04684628 ↗ |
| Known as | 68Ga PSMA-HBED-CC | “This is a study primarily comparing Magnetic Resonance Imaging (MRI) alone to Positron Emission Tomography (PET)/MRI using an experimental tracer, 68Ga-PSMA-HBED-CC, among men...” NCT03439033 ↗6“This is an expanded access program using 68Ga PSMA-HBED-CC (68Ga-PSMA-11).” NCT05415228 ↗ |
| Known as | 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11) | “68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11)” NCT02673151 ↗ |
| Known as | [68Ga]Ga-PSMA-11 | “two similar PET agents, [68Ga]Ga-P16-093 and [68Ga]Ga-PSMA-11, in the same group of primary prostate cancer (PCa) patients.” PMID 37233785 ↗ May 2023 |
| Known as | Ga-68 labeled PSMA-11 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02918357 ↗ |
| Known as | Ga-68-PSMA-11 | “The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in...” NCT03353740 ↗ |
| Known as | Gallium (68Ga) gozetotide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06881823 ↗ |
| Known as | gallium Ga 68 gozetotide | “Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11” NCT05558956 ↗ |
| Known as | Gallium-68 labeled HBED-CC PSMA | “Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) has recently been approved by the FDA for clinical use” NCT05415228 ↗ |
| Known as | Gallium-68 labeled PSMA-HBED-CC | “Subjects have one visit, during which they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical” NCT03439033 ↗ |
| Known as | Gallium-68 PSMA-11 | “This is a pilot study to investigate the evaluate to use of a drug/radiopharmaceutical called Gallium-68 PSMA-11 (68Ga-PSMA-11) for use in PET/MRI evaluation of hepatocellular carcinoma” NCT03982407 ↗ |
| Known as | Illuccix | “Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11” NCT05558956 ↗ |
| Known as | PSMA-HBED\_CC | “68Ga labeled PSMA -11 (or PSMA-HBED\_CC) PET/MRI scan” NCT03982407 ↗ |
| Modality | Diagnostic / imaging agent | “as specific PET-tracers” NCT02659527 ↗ |
| Route | Intravenous | “68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.” NCT02673151 ↗ |