Drugs / 18F-FET
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | low grade glioma | 2026-03-16 | “TLX101-Px, (Floretyrosine F 18 or 18F-FET): Telix has resubmitted its NDA in the U.S.” telixpharma.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01756352 | Feb 2013 → Sep 2015 | glioblastoma | Marcelo F. Di Carli, MD, FACC | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07475390 | Feb 2026 → Dec 2027 expected | brain glioma | Tomsk National Research Medical Center of the Russian Academy of Sciences | Active not recruiting | No outcome recorded |
| — | NCT07366710 | Nov 2024 → Oct 2027 expected | NAFLD1, glucose metabolism disease | Rigshospitalet, Denmark | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT05450744 Background | Apr 2023 → Jun 2026 overdue | glioblastoma | Telix Pharmaceuticals (Innovations) Pty Limited | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-09-13 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory FDA Approves Telix’s Brain Cancer Imaging Drug Pixclara telixpharma.com ↗
Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Pixclara® (floretyrosine F 18 or 18F-FET), an amino acid positron emission tomography (PET) drug for imaging gliomas (brain cancer). |
| 2026-05-01 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory TLX101-Px (Pixlumi®) MAA Accepted in Europe telixpharma.com ↗
Telix today announces that the marketing authorization application (MAA) filed in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate[1], has been validated and accepted for review. |
| 2026-04-10 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory FDA Accepts NDA for TLX101-Px (Pixclara®) telixpharma.com ↗
FDA Accepts NDA for TLX101-Px (Pixclara®) |
| 2026-04-07 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Q1 2026: Strong Revenue Growth and Therapeutics Pipeline Advancement telixpharma.com ↗
Telix has resubmitted its NDA in the U.S. with the additional clinical data and analysis as agreed with the FDA. |
| 2026-03-16 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate telixpharma.com ↗
Telix has resubmitted the NDA with the additional data requested by the FDA. |
| 2026-02-17 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Submits European Marketing Authorization Application for TLX101-Px for Brain Cancer Imaging telixpharma.com ↗
Telix today announces that it has submitted a marketing authorization application (MAA) in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate. |
| 2024-10-23 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent telixpharma.com ↗
Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara®[1]), an agent for the imaging of glioma. |
| 2024-09-03 | Telix Pharmaceuticals (Innovations) Pty Limited | Results IPAX-1 Study of TLX101 Investigational Glioblastoma Therapy Published in Neuro-Oncology Advances telixpharma.com ↗
At the 3-month follow-up, 6 patients demonstrated metabolic stable disease with 18F-FET PET imaging. |
| 2024-08-27 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Submits NDA for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent telixpharma.com ↗
Telix today announces it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-CDx |
| 2024-07-29 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Expanded Access Program Opens in the U.S. for TLX101-CDx, Telix’s Investigational Glioma (Brain Cancer) Imaging Agent telixpharma.com ↗
Telix today announces the opening of an expanded access program (EAP) in the United States (U.S.) for TLX101-CDx (Pixclara®1, 18F-floretyrosine or 18F-FET) an investigational positron emission tomography (PET) agent for imaging progressive or recurrent glioma, following U.S. Food and Drug Administration (FDA) agreement to proceed. |
| 2024-04-15 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory TLX101-CDx (Pixclara™) Granted FDA Fast Track Designation telixpharma.com ↗
Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET). |
| 2023-04-11 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药全球创新放射性核素偶联药物TLX101国内I期临床研究获批 grandpharm.com ↗
近日，远大医药(00512.HK)用于治疗胶质母细胞瘤(GBM)的全球创新放射性核素偶联药物(RDC) TLX101已获得国家药监局(NMPA)默示许可，在中国开展I期临床研究。 |
| 2023-04-10 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Chinese NMPA Approves Study of Telix Brain Cancer Therapy Candidate telixpharma.com ↗
Telix today announces the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved a Phase I study of TLX101 investigational therapy (4-L-[131I] iodo-phenylalanine, or 131I-IPA) in Chinese patients with newly diagnosed glioblastoma (GBM). |
| 2023-02-27 | GrandPharma (China) Co., Ltd. | Regulatory 新序启 | 远大医药产品收获新进展（2月篇） grandpharm.com ↗
2月，全球创新放射性核素偶联药物TLX101(131I-IPA)中国IND申请获受理，TLX101是一种用于治疗多形性胶质母细胞瘤的治疗型放射性药物，已在美国及欧洲获得孤儿药认定，有望成为胶质母细胞瘤治疗领域中的一种开拓性的治疗手段。 |
| 2023-02-06 | GrandPharma (China) Co., Ltd. | Regulatory 远大医药全球创新放射性核素偶联药物TLX101中国IND申请获受理 grandpharm.com ↗
近日，远大医药(00512.HK)用于治疗多形性胶质母细胞瘤(GBM)的全球创新放射性核素偶联药物(RDC) TLX101的新药临床试验(IND)申请已获得国家药监局(NMPA)正式受理，为本集团在核药抗肿瘤诊疗领域的重要研发进展。 |
| 2020-10-06 | Telix Pharmaceuticals (Innovations) Pty Limited | Regulatory Telix Granted FDA Orphan Drug Designation for Glioma Imaging Agent telixpharma.com ↗
Telix Pharmaceuticals Limited is pleased to announce that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for O-(2-[18F]fluoroethyl)-L-tyrosine (18F-FET), for the positron emission tomography (PET) imaging of glioma, a type of brain tumour. |
All press releases naming this drug 16 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 18F-FET | “18F-FET: injection/solution administrated intravenously” NCT05450744 ↗ |
| Known as | O-(2-\[18F\]fluoroethyl)-L-tyrosine | “Oral administration of O-(2-\[18F\]fluoroethyl)-L-tyrosine (18F-FET) for total-body PET/CT to assess gastrointestinal amino acid absorption and whole-body amino acid metabolism.” NCT07366710 ↗ |
| Modality | Diagnostic / imaging agent | “The PET radiotracer FET provides a measure of large, neutral amino acid transport.” NCT01756352 ↗ |
| Route | Intravenous | “18F-FET: injection/solution administrated intravenously” NCT05450744 ↗ |