TheraRadar
Data updated: May 26, 2026

KYXATA (carboplatin)

Trial Activity: Stable 625 active trials
Oncology Approved 2025-08-08

KYXATA is a platinum-based drug used for adults with advanced ovarian carcinoma. It is often used as part of a combination regimen for patients who are starting their first round of therapy. Doctors also prescribe it as a single-agent for patients whose ovarian cancer has returned after they have already received chemotherapy.

Source: FDA Label • AVYXA HOLDINGS • Platinum-based Drug

How KYXATA Works

This drug works by binding directly to DNA to form cross-links. These cross-links prevent the cell from replicating or transcribing its DNA. This process triggers cell death, which helps stop the growth of the cancer.

Development Insights

National Cancer Institute (NCI) conducting 93 trials (6%)
1939 indications explored (Broad Platform)
non-small cell lung cancer (126 trials)
breast cancer (75 trials)
ovarian cancer (73 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-08-08
Patent Cliff
2045

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: CARBOPLATIN

KYXATA Approval History

2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2025 to 2025
Aug 2025 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer

What KYXATA Treats

1 indications

KYXATA is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Ovarian Carcinoma
Source: FDA Label

KYXATA Boxed Warning

HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity reactions, including anaphylaxis, can occur with KYXATA within minutes of administration during any cycle. Immediately discontinue KYXATA for severe hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity...

KYXATA Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in KYXATA's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications KYXATA treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to KYXATA

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

DOXIL (LIPOSOMAL)
DOXORUBICIN HYDROCHLORIDE
1 shared
Baxter
Shared indications:
Ovarian Carcinoma
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
DOXORUBICIN HYDROCHLORIDE
1 shared
Baxter
Shared indications:
Ovarian Carcinoma
📋

Clinical Trial Registry

1418 trials
Trial Sponsor ID Phase Status Title
NCT03604991 NCI-2018-01575 NCI-2018-01575, EA2174 Ph 2, Ph 3 suspended Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery
NCT07396324 NEO-ITHRAN LY2025-422-A Ph 2 recruiting Neoadjuvant QL1706 in Patients With Hormone Receptor Positive, HER2-negative Breast Cancer
NCT06172296 NCI-2023-08530 NCI-2023-08530, ANBL2131 Ph 3 recruiting Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
NCT03606967 NCI-2018-01581 NCI-2018-01581, 10146 Ph 2 recruiting Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
NCT06528691 GLOBOTRK NCI-2024-02977 Ph 2 recruiting Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
NCT07198074 NCI-2025-06974 NCI-2025-06974, NRG-GY035 Ph 3 recruiting Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
NCT06875310 CA239-0004 CA2390004 Ph 3 recruiting A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
NCT07281417 NCI-2025-09016 NCI-2025-09016, 10721 Ph 2 recruiting Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma
NCT03017326 PHITT RG_15-114 Ph 3 active not recruiting Paediatric Hepatic International Tumour Trial
NCT05019716 NCI-2021-08926 NCI-2021-08926, 10507 Ph 1, Ph 2 recruiting Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma
NCT07129993 DS1062-328 Ph 2, Ph 3 recruiting Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
NCT07221474 INTerpath-13 V940-013 V940-013, U1111-1318-2495 Ph 2 recruiting A Study of Intismeran Autogene (V940)/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)
NCT07283692 LY2025-277-A Ph 2 recruiting Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)
NCT07005102 M25-287 2024-518586-10 Ph 2, Ph 3 recruiting A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
NCT01081951 results posted D0810C00041 2009-015970-36 Ph 2 active not recruiting Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer
NCT04166409 NCI-2019-07600 NCI-2019-07600, ACNS1833 Ph 3 recruiting A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
NCT07583550 2026 049 A Ph 2 not yet recruiting Low-dose Thoracic Radiotherapy Followed by Adebrelimab Plus Chemotherapy, and Then Sequential Maintenance Therapy With Adebrelimab for Extensive-stage Small Cell Lung Cancer
NCT06524544 NCI-2024-06208 NCI-2024-06208, EA8231 Ph 3 recruiting A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitean-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
NCT06151574 1479-0008 2023-504308-27-00, U1111-1294-1407 Ph 3 active not recruiting Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
NCT07504588 NCI-2026-01998 NCI-2026-01998, NRG-GY038 Ph 2 not yet recruiting Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
NCT03793179 NCI-2018-03695 NCI-2018-03695, EA5163 Ph 3 active not recruiting Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
NCT07155174 SEZanne M24-633 2024-517490-24 Ph 2 recruiting A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer
NCT07061977 NCI-2025-04695 NCI-2025-04695, NRG-GY037 Ph 3 recruiting Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
NCT05063552 NCI-2021-10021 NCI-2021-10021, EA3202 Ph 2, Ph 3 active not recruiting Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
NCT01251874 NCI-2011-02552 NCI-2011-02552, CDR0000688990 Ph 1 active not recruiting Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer
NCT04274426 MIROVA AGO-OVAR 2.34 2018-004207-39, 2024-516959-40-00 Ph 2 active not recruiting Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer
NCT07195734 NCI-2025-06920 NCI-2025-06920, NRG-HN015 Ph 2 recruiting Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
NCT05256225 NCI-2022-01540 NCI-2022-01540, NRG-GY026 Ph 3 recruiting Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma
NCT06772623 M24-536 2024-514465-18, 2024-514465-18-00 Ph 1, Ph 2 recruiting Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations
NCT03907475 NCI-2019-01886 NCI-2019-01886, 10292 Ph 2 recruiting Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial
NCT06843447 5909-003 MK-5909-003, 2024-514674-47-00 Ph 1, Ph 2 recruiting A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
NCT05058651 NCI-2021-09851 NCI-2021-09851, S2012 Ph 2, Ph 3 recruiting Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
NCT04267848 NCI-2020-00751 NCI-2020-00751, A081801 Ph 3 recruiting Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
NCT06694454 10001609 001609-C Ph 1, Ph 2 recruiting Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)
NCT06029270 NCI-2023-06678 NCI-2023-06678, NRG-HN011 Ph 2 recruiting Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
NCT05775289 results posted BO44178 Ph 2 active not recruiting A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer
NCT06890338 M25-231 GOG-3115 Ph 2 recruiting A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
NCT05001880 NCI-2021-08573 NCI-2021-08573, A092001 Ph 2 recruiting Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma
NCT06448754 eVOLVE-01 D798KC00001 2023-509482-20-00 Ph 2 recruiting Volrustomig Priming Regimens Exploratory Phase II Platform Study
NCT05198830 NCI-2021-14403 NCI-2021-14403, CASE1522 Ph 2 recruiting Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer
NCT03337698 Morpheus Lung results posted BO39610 2017-001267-21 Ph 1, Ph 2 terminated A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
NCT06077500 DAREONᵀᴹ-8 1438-0008 Ph 1 active not recruiting DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer
NCT05420948 IRB22-0288 Ph 2 recruiting A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer
NCT04245085 ABC-lung results posted ETOP 15-19 MO40586 Ph 2 completed ABC-lung: Atezolizumab, Bevacizumab and Chemotherapy in EGFR-mutant Non-small Cell Lung Carcinoma
NCT06119581 SUNRAY-01 18612 J3M-MC-JZQB, U1111-1288-0565 Ph 3 recruiting A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
NCT07472517 1438-0012 2025-520565-51-00, U1111-1317-4955 Ph 3 recruiting DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy
NCT06132113 1438-0007 U1111-1292-1400, 2023-505870-13-00 Ph 1 recruiting DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers
NCT03819465 MAGELLAN D933IC00001 2018-001748-74 Ph 1 active not recruiting A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC
NCT02445391 results posted EA1131 NCI-2014-01820, EA1131 Ph 3 active not recruiting Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
NCT05351788 SKB264-Ⅱ-05 Ph 2 recruiting SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

Showing 50 of 1418 trials

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

KYXATA FDA Label Details

Indications & Usage

FDA Label (PDF)

KYXATA is indicated for the treatment of Ovarian Carcinoma.

⚠️ BOXED WARNING

WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity reactions, including anaphylaxis, can occur with KYXATA within minutes of administration during any cycle. Immediately discontinue KYXATA for severe hypersensitivity reactions and administer appr...

View full patent landscape →
1 OB patents · 1 families · 1 international docs across 1 countries

KYXATA Patents & Exclusivity

Latest Patent: Apr 2045

Patents (1 active)

US12427104 Expires Apr 1, 2045
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for KYXATA

Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2045
  • 9 active patents

Trial Analysis

  • 1439 total trials
  • Stage: Stable

Competitive Landscape

  • 2 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment