Data updated: Nov 8, 2026
CABOZANTINIB S-MALATE · Cipla
Approved 2012-11-29
CABOZANTINIB S-MALATE is FDA-approved to treat 5 conditions (same as CABOMETYX).
Source: FDA Label
2
Indications
--
Phase 3 Trials
13
Years on Market
Details
- Status
- Prescription
- First Approved
- 2012-11-29
- Routes
- ORAL
- Dosage Forms
- TABLET
CABOZANTINIB S-MALATE Approval History
Original
New Indication
New Form
Label Update
6 FDA actions from 2026 to 2026
Oct 2026 ORIGINAL
Update
What CABOZANTINIB S-MALATE Treats
5 indicationsCABOZANTINIB S-MALATE is approved for 5 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Advanced renal cell carcinoma
- Hepatocellular carcinoma previously treated with sorafenib
- Locally advanced or metastatic differentiated thyroid cancer
- Well-differentiated pancreatic neuroendocrine tumors
- Well-differentiated extra-pancreatic neuroendocrine tumors
Same approved indications as CABOMETYX (same active ingredient).
Source: FDA Label
Cipla's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
📋
Clinical Trial Registry
39 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04310007 | NCI-2020-01541 NCI-2020-01541, EA5191 | Ph 2 | active not recruiting | Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer |
| NCT04071223 | NCI-2019-05619 NCI-2019-05619, A031801 | Ph 2 | active not recruiting | Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, RadiCaL Study |
| NCT05111574 | NCI-2021-11794 NCI-2021-11794, A091903 | Ph 2 | active not recruiting | Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery |
| NCT02496208 | NCI-2014-02379 NCI-2014-02379, 15-C-0160 | Ph 1 | active not recruiting | Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors |
| NCT05136196 | NCI-2021-12653 NCI-2021-12653, S2101 | Ph 2 | recruiting | BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study |
| NCT05691478 | NCI-2022-08567 NCI-2022-08567, AOST2032 | Ph 2, Ph 3 | suspended | A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma |
| NCT03866382 | NCI-2019-01266 NCI-2019-01266, A031702 | Ph 2 | recruiting | Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors |
| NCT06811116 | NCI-2025-00837 NCI-2025-00837, 25-082 | Ph 1, Ph 2 | recruiting | Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial |
| NCT05904080 | NCI-2023-04469 NCI-2023-04469, A092105 | Ph 2 | suspended | Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer |
| NCT05411081 | NCI-2022-04668 NCI-2022-04668, S2200 | Ph 2 | active not recruiting | Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer, PAPMET2 Trial |
| NCT05092958 | NCI-2021-11166 NCI-2021-11166, A032001 | Ph 3 | active not recruiting | Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study |
| NCT04339738 results posted | NCI-2020-02153 NCI-2020-02153, A091902 | Ph 2 | active not recruiting | Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma |
| NCT03375320 results posted | NCI-2017-02297 NCI-2017-02297, A021602 | Ph 3 | active not recruiting | Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors |
| NCT01708954 results posted | NCI-2012-01938 NCI-2012-01938, ECOG-E1512 | Ph 2 | active not recruiting | Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer |
| NCT04878029 | STUDY00002329 NCI-2021-01365, STUDY00002329 | Ph 1 | recruiting | Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer |
| NCT03367741 results posted | NCI-2017-02211 NCI-2017-02211, PHL-099 | Ph 2 | active not recruiting | Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer |
| NCT02243605 results posted | NCI-2014-01927 NCI-2014-01927, CABONE | Ph 2 | active not recruiting | Cabozantinib S-malate in Treating Patients With Relapsed Osteosarcoma or Ewing Sarcoma |
| NCT02867592 results posted | NCI-2016-01258 NCI-2016-01258, ADVL1622 | Ph 2 | active not recruiting | Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors |
| NCT03914300 results posted | NCI-2019-02220 NCI-2019-02220, OSU-19088 | Ph 2 | active not recruiting | Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer |
| NCT04079712 results posted | NCI-2019-05864 NCI-2019-05864, 10315 | Ph 2 | active not recruiting | Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors |
| NCT04514484 results posted | NCI-2020-05956 NCI-2020-05956, 2020-12258 | Ph 1 | active not recruiting | Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV |
| NCT05122546 | 21133 NCI-2021-05559, 21133 | Ph 1 | active not recruiting | CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer |
| NCT06006013 | STUDY00005532 NCI-2023-04952, STUDY00005532 | Ph 2 | recruiting | Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Cancer |
| NCT05092373 | 2021-0299 NCI-2021-11360, 2021-0299 | Ph 1 | recruiting | Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax |
| NCT01935934 results posted | NCI-2013-00890 NCI-2013-00890, PHL-086 | Ph 2 | completed | Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer |
| NCT02302833 results posted | 2014-0081 NCI-2014-02607, 2014-0081 | Ph 2 | completed | Cabozantinib S-malate in Treating Patients With Metastatic Pheochromocytomas or Paragangliomas That Cannot Be Removed by Surgery |
| NCT04220229 results posted | RG1003562 NCI-2019-08661, 10051 | Ph 1, Ph 2 | terminated | Cabozantinib With Radiation Therapy for the Treatment of Sarcomas of the Extremities |
| NCT05168618 AtezoCab | 143814 NCI-2021-13110, HCI143814 | Ph 2 | active not recruiting | Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer |
| NCT02761057 results posted | NCI-2015-01707 NCI-2015-01707, S1500 | Ph 2 | completed | Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed |
| NCT01709435 results posted | NCI-2012-01890 NCI-2012-01890, P121149 | Ph 1 | completed | Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors |
| NCT04442581 results posted | RG1007034 NCI-2020-03968, 10548 | Ph 2 | terminated | Cabozantinib and Pembrolizumab for the First-Line Treatment of Advanced Liver Cancer |
| NCT01822522 results posted | NCI-2013-00740 NCI-2013-00740, AMC-087 | Ph 1 | completed | Cabozantinib S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus |
| NCT05327738 | STUDY00023365 NCI-2022-01840, STUDY00023365 | Ph 2 | withdrawn | Yttrium Y 90 Glass Microspheres, Atezolizumab, and Cabozantinib for the Treatment of Unresectable or Locally Advanced Hepatocellular Carcinoma |
| NCT01835145 results posted | NCI-2013-00821 NCI-2013-00821, CALGB-A091201 | Ph 2 | completed | Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery |
| NCT01835158 results posted | NCI-2013-00820 NCI-2013-00820, A031203 | Ph 2 | completed | Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer |
| NCT02315430 results posted | NCI-2014-02411 NCI-2014-02411, NRG-GY001 | Ph 2 | completed | Cabozantinib-S-Malate in Treating Patients With Recurrent or Progressive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
| NCT01716715 results posted | NCI-2012-02058 NCI-2012-02058, GOG-0186K | Ph 2 | completed | Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer |
| NCT01866410 results posted | NCI-2013-01085 NCI-2013-01085, PHII-125 | Ph 2 | completed | Cabozantinib-S-Malate and Erlotinib Hydrochloride in Treating Patients With Previously Treated Metastatic Non-Small Cell Lung Cancer |
| NCT01811212 results posted | NCI-2013-00554 NCI-2013-00554, 2012C0101 | Ph 2 | completed | Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CABOZANTINIB S-MALATE FDA Label Details
Indications & Usage
CABOZANTINIB S-MALATE is FDA-approved to treat 5 conditions — same approved indications as CABOMETYX.
Looking for the branded version?
CABOMETYX
Full clinical data, patents, trials, and competitive landscape for cabozantinib s-malate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.