Drugs / 89Zr-TLX250
89Zr-TLX250
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | Zircaix | clear cell papillary renal cell carcinoma | 2025-08-27 | “On 27 August 2025, partner Telix Pharmaceuticals Limited, Melbourne, Australia (Telix) received a Complete Response Letter (CRL) from the FDA for the diagnostic agent TLX250-CDx.” heidelberg-pharma.com ↗ “Telix has recently participated in a Type A meeting to discuss the CRL it received following review of the Biologics License Application (BLA)[10] for TLX250-CDx” telixpharma.com ↗ “Zircaix®18 (TLX250-CDx, 89Zr-DFO-girentuximab): Following the receipt of a Complete Response Letter from the FDA in August 2025” telixpharma.com ↗ “Today, Telix published that it has received a Complete Response Letter (CRL) from the FDA for the BLA for TLX250-CDx” heidelberg-pharma.com ↗ “Positive Type A meeting held with the FDA to align on remediation of CMC deficiencies identified in the CRL.” telixpharma.com ↗ |
| Filed | US (FDA) | — | clear cell papillary renal cell carcinoma | 2024-06-05 | “TLX250-CDx已完成向美国FDA递交用于诊断肾透明细胞癌(ccRCC)的生物制品上市许可申请(BLA)” grandpharm.com ↗ |
| Filed | US (FDA) | — | clear cell papillary renal cell carcinoma | 2023-12-22 | “In December 2024, the Australian partner Telix Pharmaceuticals Limited, Melbourne, (Telix) completed the submission of the revised Biologics License Application (BLA) for its...” heidelberg-pharma.com ↗ “已向美国食品药品监督管理局(FDA)递交了用于诊断肾透明细胞癌(ccRCC)的全球创新RDC药物TLX250-CDx的生物制品上市许可申请(BLA)。” grandpharm.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05861778 | Jun → Nov 2023 | clear cell renal carcinoma | Telix Pharmaceuticals (Innovations) Pty Limited | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04758780 | Sep 2021 → Mar 2023 | triple-negative breast carcinoma | Institut Cancerologie de l'Ouest | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06750419 | Nov 2024 → Jun 2026 overdue | clear cell renal carcinoma | Telix Pharmaceuticals (Innovations) Pty Limited | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 31
| Date | Issuer | Release |
|---|---|---|
| 2026-05-05 | Telix Pharmaceuticals (Innovations) Pty Limited | Results New Publication Demonstrates TLX250-Px (Zircaix®) Potential in Diagnosing Kidney Cancers Beyond ccRCC telixpharma.com ↗
This analysis shows that when TLX250-Px PET/CT is positive, it is highly predictive of renal malignancy, including beyond ccRCC. |
| 2026-01-12 | GrandPharma (China) Co., Ltd. | Results 远大医药创新RDC药物TLX250-CDx的中国I期研究结果发表于《欧洲核医学与分子影像研究杂志》 grandpharm.com ↗
作者总结道，TLX250-CDx在I期研究的中国患者中具有良好的安全性和耐受性，其器官辐射剂量学和肿瘤剂量学先前在其他人群中的报告相似。 |
| 2026-01-09 | Telix Pharmaceuticals (Innovations) Pty Limited | Results ZIRDOSE-CP Study of TLX250-CDx published in EJNMMI Research: Confirms Favorable Safety and Tolerability Profile in Chinese patients telixpharma.com ↗
Authors conclude that TLX250-CDx “has a favorable safety and tolerability profile in Chinese patients, with a similar organ radiation and tumor dosimetry as previously reported in other populations”. |
| 2025-11-19 | Telix Pharmaceuticals (Innovations) Pty Limited | Results ZIRCON-X Analysis: TLX250-CDx Impacts Clinical Decision Making for Almost Half of Patients with Indeterminate Renal Masses telixpharma.com ↗
The study found that 143 patients (48.6%) would have undergone a change in clinical management if imaged with TLX250-CDx, and over 20% of these patients (31 out of 143) could have potentially avoided invasive biopsy[5]. |
| 2025-11-11 | Telix Pharmaceuticals (Innovations) Pty Limited | Results OPALESCENCE Trial Published in EJNMMI: Confirms Theranostic Potential of TLX250-CDx in Breast Cancer telixpharma.com ↗
Telix today announces that final positive results from the Phase 2 OPALESCENCE trial[1] of TLX250-CDx (89Zr-girentuximab) in metastatic triple negative breast cancer (mTNBC) have been published in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI)[2]. |
| 2025-08-28 | Heidelberg Pharma AG | Regulatory AH: Heidelberg Pharma’s Partner Telix Pharmaceuticals Gives Regulatory Update for its Imaging Agent TLX250-CDx heidelberg-pharma.com ↗
Today, Telix published that it has received a Complete Response Letter (CRL) from the FDA for the BLA for TLX250-CDx ( Telix ASX Announcement ). |
| 2025-02-25 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review telixpharma.com ↗ |
| 2024-12-29 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Files TLX250-CDx (Zircaix®) BLA for Kidney Cancer Imaging telixpharma.com ↗
Telix today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®[1], 89Zr- girentuximab) kidney cancer imaging[2]. |
| 2024-09-10 | Telix Pharmaceuticals (Innovations) Pty Limited | Results ‘Highly Accurate’: Telix’s Phase III ZIRCON Trial for Kidney Cancer Imaging Published in The Lancet Oncology telixpharma.com ↗
Authors conclude that TLX250-CDx “has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of ccRCC, which has the potential to be practice changing.” |
| 2024-06-05 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药全球创新放射性核素偶联药物TLX591及TLX250-CDx取得临床进展 grandpharm.com ↗
用于诊断肾透明细胞癌(ccRCC)的TLX250-CDx已完成向美国FDA递交生物制品上市许可申请(BLA)。 |
| 2024-05-14 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Telix Announces Abstract Presentations at BNMS Annual Spring Meeting telixpharma.com ↗
89Zr-DFO-girentuximab PET-CT imaging can accurately detect clear cell renal cell carcinoma primary and secondary lesions in patients with renal masses at conventional imaging, results from ZIRCON phase III study |
| 2023-12-22 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药全球创新放射性核素偶联药物TLX250-CDx已向美国FDA递交BLA申请 grandpharm.com ↗
近日，远大医药(0512.HK)在放射性核素偶联药物(RDC)领域的重要战略合作伙伴Telix Pharmaceuticals Limited (Telix, ASX: TLX)已向美国食品药品监督管理局(FDA)递交了用于诊断肾透明细胞癌(ccRCC)的全球创新RDC药物TLX250-CDx的生物制品上市许可申请(BLA)。 |
| 2023-12-18 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Submits Biologics License Application (BLA) for TLX250-CDx (Zircaix™) for Imaging of Kidney Cancer telixpharma.com ↗
Telix today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for its investigational positron emission tomography (PET) imaging agent TLX250-CDx (Zircaix™,[1] 89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC). |
| 2023-12-06 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Positive Topline Results from Phase II OPALESCENCE Study of TLX250-CDx in Triple Negative Breast Cancer Presented at SABCS telixpharma.com ↗
Telix announces positive topline results from the Phase II OPALESCENCE investigator-initiated trial (IIT) of its carbonic anhydrase IX (CAIX)-targeting positron emission tomography (PET) imaging candidate, TLX250-CDx (89Zr-DFO-girentuximab), in patients with triple negative breast cancer (TNBC). |
| 2023-06-26 | Telix Pharmaceuticals (Innovations) Pty Limited | Results New ZIRCON Phase III Data Presented at SNMMI: Potential Utility of TLX250-CDx in Staging and Monitoring ccRCC telixpharma.com ↗
New data demonstrates the ability of TLX250-CDx to detect extrarenal lesions, supporting potential clinical utility in the metastatic or recurrent setting, and for staging and informing treatment decisions. |
| 2023-06-22 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Telix to Showcase ZIRCON Phase III Kidney Cancer Imaging Data and Theranostic Pipeline Developments at SNMMI telixpharma.com ↗
89Zr-DFO-girentuximab PET/CT imaging can accurately detect clear cell renal cell carcinoma (ccRCC) primary and secondary lesions in patients with renal masses at conventional imaging, results from ZIRCON Phase III study |
| 2023-04-30 | Telix Pharmaceuticals (Innovations) Pty Limited | Results ZIRCON Phase III Kidney Cancer Imaging Study Presented at AUA: New Data Confirms Efficacy in Masses 2cm or Smaller telixpharma.com ↗
Telix today announces additional positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118). |
| 2023-03-13 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Telix’s ZIRCON Phase III Kidney Cancer Imaging Study Presented in “Game Changing” Session at EAU telixpharma.com ↗
Telix today announces additional positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118). |
| 2023-02-19 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Detailed Results from Telix’s ZIRCON Phase III Kidney Cancer Imaging Study Presented at ASCO GU telixpharma.com ↗
Telix today announces detailed positive results from its completed pivotal Phase III ZIRCON trial (ClinicalTrials.gov Identifier: NCT03849118)1. |
| 2022-11-07 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma’s Partner Telix Reports Positive Data on the Pivotal ZIRCON Study heidelberg-pharma.com ↗
The study has also met the key secondary endpoint, achieving 85% sensitivity and 89% specificity in detecting ccRCC in tumors <4 cm (“T1a” classification), currently a significant clinical challenge in the diagnosis of ccRCC. |
| 2022-11-06 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Telix Announces Positive Topline Results of ZIRCON Phase III Kidney Cancer Imaging Study telixpharma.com ↗
Telix today announces highly positive top-line results from the pivotal Phase III ZIRCON study (Zirconium in Renal Cancer Oncology, NCT03849118) of its investigational renal (kidney) cancer positron emission tomography (PET) imaging agent, TLX250-CDx (89Zr-DFO-girentuximab). |
| 2022-10-23 | GrandPharma (China) Co., Ltd. | Results 远大医药全球创新RDC药物TLX250-CDx两项拓展适应症临床研究取得初步数据 grandpharm.com ↗
OPALESCENCE的初步数据已证明TLX250-CDx靶向TNBC表达的CA9的可行性，并展现了该产品的应用潜力——83%的患者病灶出现CA9的高表达，使得TLX250-CDx免疫PET成像检测可行，并为进一步研究提供依据。 |
| 2022-10-17 | Telix Pharmaceuticals (Innovations) Pty Limited | Results TLX250-CDx Indication Expansion: Preliminary Data Presented at EANM telixpharma.com ↗
OPALESCENCE Phase II study of TLX250-CDx in triple-negative breast cancer reports preliminary data as a top-rated oral presentation at EANM |
| 2022-09-28 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Chinese NMPA Approves Study of Telix Kidney Cancer Imaging Candidate telixpharma.com ↗
Chinese NMPA Approves Study of Telix Kidney Cancer Imaging Candidate |
| 2022-08-11 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药全球创新RDC药物TLX591-CDx及TLX250-CDx IND申请获国家药监局受理 grandpharm.com ↗
2022年8月1日，远大医药(0512.HK)公布，集团放射性核素偶联药物(RDC)领域用于诊断前列腺癌的药物TLX591-CDx (Illuccix®, gallium Ga 68 PSMA-11)以及用于诊断透明细胞肾细胞癌(ccRCC)的药物TLX250-CDx (89Zr-DFO-girentuximab)的临床试验申请(IND)近日获得国家药监局(NMPA)正式受理。 |
| 2022-08-02 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory APAC Report: Regulatory Progress for Prostate and Kidney Cancer Imaging telixpharma.com ↗
An IND application has been submitted by Grand Pharma to the NMPA CDE (and accepted for review) |
| 2021-04-21 | Telix Pharmaceuticals (Innovations) Pty Limited | Results Japanese Renal Cancer Imaging Trial Meets Study Objectives telixpharma.com ↗
Telix announces the Company’s ZIRDAC-JP study of its renal cancer imaging product demonstrates safety and tolerability in Japanese patients. |
| 2020-07-01 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Granted FDA Breakthrough Therapy Designation for Renal Cancer Imaging Product telixpharma.com ↗
Telix Pharmaceuticals Limited is pleased to announce that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy (BT) designation for Telix’s renal cancer imaging product TLX250-CDx (89Zr-girentuximab). |
| 2020-01-23 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Granted FDA Approval for ZIRCON Renal Cancer Imaging telixpharma.com ↗
Telix Pharmaceuticals Limited has today announced that the US Food and Drug Administration has approved the ZIRCON study for recruitment of American patients. |
| 2019-12-24 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory ZIRCON Phase 3 IND Submitted to the US FDA telixpharma.com ↗
Melbourne (Australia) – 24 December 2019. Telix Pharmaceuticals Limited announces that it has submitted a Phase 3 IND application to the FDA for TLX250-CDx |
| 2019-08-30 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Cleared to Commence Renal Cancer Imaging Study in Japan telixpharma.com ↗
The Japanese Pharmaceutical and Medical Devices Agency (PMDA) has completed review of the proposed clinical trial and Telix is now permitted to proceed with the study. |
All press releases naming this drug 47 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 89Zr-TLX250 | “The study is designed to evaluate the safety, tolerability, radiation dosimetry and pharmacokinetics 89Zr-TLX250 (also known as 89Zr-DFO-girentuximab) Positron Emission...” NCT05861778 ↗ |
| Known as | girentuximab | “89Zr-TLX250, is a chimeric monoclonal antibody (INN name: girentuximab) with specificity for the CAIX (carbonic anhydrase 9) antigen, radiolabelled with the positron emitting...” NCT06750419 ↗ |
| Known as | TLX250-CDx | “[89Zr]Zr-DFO-89Zr-girentuximab (TLX250-CDx) positron emission tomography/computed tomography (PET/CT)” PMID 41174094 ↗ Nov 2025 |
| Modality | Monoclonal antibody | “a radiolabeled monoclonal antibody that recognizes carbonic anhydrase IX (CAIX)” NCT04758780 ↗ |
| Route | Intravenous | “Intravenous administration of 37±10% MBq TLX250-CDx was performed” PMID 41174094 ↗ Nov 2025 |