For delayed methotrexate clearance (plasma methotrexate concentrations greater than 2…. Sold as Voraxaze. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Glucarpidase (sold as Voraxaze), first approved Jan 17, 2012, with 0 new uses approved and 0 published complete response letters.
| Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate CancerMetastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 · National Cancer Institute (NCI) | Phase 2 | Not yet recruiting | Nov 4, 2026 |
| Pluvicto for the Treatment of African American Men With Metastatic Castration-Resistant Prostate CancerMetastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 · Emory University | Phase 2 | Not yet recruiting | Oct 6, 2026 |
| Measuring Circulating Tumor Deoxyribonucleic Acid Tumor Fraction to Guide Early 177Lu-PSMA-617 Treatment Discontinuation in Patients With Metastatic Castration-Resistant Prostate Cancer, DYNAMO TrialMetastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 · University of Washington | Phase 2 | Recruiting | Jul 13, 2026 |
| Focal Radiation Therapy (HDR-Brachytherapy) for the Treatment of Prostate CancerProstate Adenocarcinoma, Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8 · Jonsson Comprehensive Cancer Center | Not applicable | Recruiting | Mar 13, 2026 |
| 177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate CancerMetastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 · City of Hope Medical Center | Phase 1 | Recruiting | Oct 21, 2025 |
| Targeted Treatment for Metastatic Prostate Cancer, The PREDICT TrialCastration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8 · Alliance for Clinical Trials in Oncology | Phase 2 | Recruiting | Oct 9, 2024 |
| Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) for Response Monitoring to Neoadjuvant AbirateroneHigh Risk Prostate Carcinoma, Prostate Cancer · Ivan de Kouchkovsky, MD | Phase 2 | Active, not recruiting | Apr 25, 2024 |
| Phase 2 Randomized Trial of Flexible Dosing Schedule of 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer (FLEX-MRT)Prostate Carcinoma, Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) v8 · Jonsson Comprehensive Cancer Center | Phase 2 | Recruiting | Jan 22, 2024 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jan 17, 2012 | VoraxazeBLA 125327 · New molecular entity | Btg International Inc | 2 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA