CAPRELSA (vandetanib)
Caprelsa treats medullary thyroid cancer that is either causing symptoms or actively progressing. It is used for patients with advanced disease that has spread to other parts of the body or cannot be removed through surgery. Because of the potential risks associated with the medication, healthcare providers carefully evaluate its use in patients whose cancer is stable or growing very slowly.
How CAPRELSA Works
This medication works by inhibiting several tyrosine kinases, such as EGFR, VEGFR, and RET, which play key roles in tumor growth and the formation of new blood vessels. By blocking these pathways, the drug helps reduce tumor-induced angiogenesis and limits the ability of cancer cells to grow and spread.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-04-06
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- TABLET
CAPRELSA Approval History
What CAPRELSA Treats
1 indicationsCAPRELSA is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Medullary Thyroid Cancer
CAPRELSA Boxed Warning
QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypocalcemia, hypokalemia and/or hypomagnesemia prior to CAPRELSA administration. Monitor electrolytes periodically. Avoid drugs known to prolong the QT interval [see Warnings and Precautions (5.1) ] . WARNING: QT P...
WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypocalcemia, hypokalemia and/or hypomagnesemia prior to CAPRELSA administration. Monitor electrolytes periodically. Avoid drugs known to prolong the QT interval [see Warnings and Precautions (5.1) ] . WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH See full prescribing information for complete boxed warning. CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypocalcemia, hypokalemia and/or hypomagnesemia prior to CAPRELSA administration. Monitor electrolytes periodically. Avoid drugs known to prolong the QT interval ( 5.1 ).
CAPRELSA Target & Pathway
ProTarget
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
CAPRELSA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to CAPRELSA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
34 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01298323 results posted | D4200C00088 LPS14815, 2010-023428-26 | Ph 3 | completed | Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment |
| NCT04211337 LIBRETTO-531 results posted | 17478 J2G-MC-JZJB, 2019-001978-28 | Ph 3 | active not recruiting | A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer |
| NCT01582191 | 2011-0953 NCI-2012-00782, 0953 | Ph 1 | completed | Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer |
| NCT02299999 SAFIR02_Breast | UC-0105/1304 2013-001652-36 | Ph 2 | active not recruiting | SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer |
| NCT06482086 | 202314711 | Ph 2 | recruiting | Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer |
| NCT02117167 SAFIR02_Lung | UC-0105/1305 / IFCT 1301 2013-001653-27 | Ph 2 | completed | SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients |
| NCT04760288 AcceleRET-MTC | CO42865 2020-005269-15 | Ph 3 | withdrawn | A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC). |
| NCT01934335 results posted | 201301763 | Ph 2 | terminated | Effect of Vandetanib on Cellular Markers in Invasive Breast Cancer |
| NCT03630120 results posted | MCC-19442 | Ph 2 | terminated | Adaptive Tyrosine Kinase Inhibitor (TKI) Therapy In Patients With Thyroid Cancer |
| NCT02495103 results posted | 150157 15-C-0157 | Ph 1, Ph 2 | terminated | Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma |
| NCT01183559 results posted | FCCC IRB 07-017 | Ph 1 | completed | A Trial of ZD6474, Paclitaxel, Carboplatin, 5-Fluorouracil, and Radiation Therapy Followed by Surgery |
| NCT01414426 results posted | 11-0265 NCI-2011-01246 | Ph 2 | completed | Vandetanib in Preventing Head and Neck Cancer in Patients With Precancerous Head and Neck Lesions |
| NCT01823068 | 2013-09-089-01 | Ph 2 | completed | Vandetanib in Advanced NSCLC With RET Rearrangement |
| NCT02015065 results posted | 130208 13-C-0208 | Ph 2 | completed | Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors |
| NCT01191892 | CDR0000684016 WCTU-TOUCAN, ISRCTN-68146831 | Ph 2 | completed | Carboplatin and Gemcitabine Hydrochloride With or Without Vandetanib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Urinary Tract Cancer |
| NCT00923247 results posted | 090089 09-C-0089 | Ph 1, Ph 2 | terminated | A Targeted Phase I/II Trial of ZD6474 (Vandetanib; ZACTIMA) Plus the Proteasome Inhibitor, Bortezomib (Velcade ), in Adults With Solid Tumors With a Focus on Hereditary or Sporadic, Locally Advanced or Metastatic Medullary Thyroid Cancer (MTC) |
| NCT01539655 Vandetanib | D4200C00101 | Ph 1 | completed | Study in Healthy Volunteers to Assess Effect of Omeprazole and Ranitidine on the Pharmacokinetics of Vandetanib |
| NCT00937417 | S0716 SWOG-S0716 | Ph 1 | withdrawn | S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors |
| NCT00481845 results posted | IRB-08051 BRSADJ0008, 97923 | Ph 2 | terminated | Phase 2 Anastrozole and Vandetanib (ZD6474) in Neoadjuvant Treatment of Postmenopausal Hormone Receptor-Positive Breast Cancer |
| NCT00686036 ZENITH results posted | D4200L00010 | Ph 2 | terminated | Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy |
| NCT00872989 results posted | CDR0000638595 S0904, U10CA032102 | Ph 2 | completed | S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer |
| NCT00777179 results posted | D4200C00077 | Ph 2 | completed | Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy |
| NCT00862836 ZACFAST results posted | D4200C00083 2008-005557-38 | Ph 1, Ph 2 | terminated | Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD) |
| NCT01544140 Vandetanib | D4200C00103 | Ph 1 | completed | Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam Administered Alone and in Combination With Vandetanib |
| NCT01561781 Vandetanib | D4200C00100 | Ph 1 | completed | Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of Digoxin Administered Alone and in Combination With Vandetanib |
| NCT01941849 VIBRaNT | UCL/12/0499 | Ph 1 | withdrawn | Phase I Trial of Vandetanib Combined With 131I-mIBG to Treat Patients With Advanced Phaeochromocytoma and Paraganglioma |
| NCT00720083 results posted | RTOG-0619 CDR0000599867 | Ph 2 | terminated | Chemotherapy and Radiation Therapy (RT) With or Without Vandetanib in Treating Patients With High-Risk Stage III or Stage IV Head and Neck Cancer |
| NCT00821080 | 07-396 | Ph 1 | completed | Vandetanib and Sirolimus in Patients With Recurrent Glioblastoma |
| NCT00683787 results posted | CDR0000596150 RPCI-I-106207 | Ph 2 | terminated | Docetaxel With or Without Vandetanib in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer |
| NCT00601614 | MC0615 MAYO-MC0615, MC0615 | Ph 1 | withdrawn | Vandetanib and Temozolomide in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery |
| NCT00660725 | 07-025 IRUSZACT0070, UPCI 07-025 | Ph 1 | completed | Study of GemOx and Vandetanib in Advanced Solid Malignancy |
| NCT00757692 | OZM-011 | Ph 2 | completed | Efficacy and Safety Study of Vandetanib (ZD 6474) in Combination With Bicalutamide Versus Bicalutamide Alone in Patients With Chemotherapy Naive Hormone Refractory Prostate Cancer. |
| NCT00734890 | 080087 08-C-0087, NCI-P7189 | Ph 1 | completed | Vandetanib and Bevacizumab in Treating Patients With Advanced Solid Tumors or Lymphoma |
| NCT00732745 | CASE6507 P30CA043703, CASE-6507 | Ph 1 | terminated | Vandetanib, Oxaliplatin, and Docetaxel in Advanced Cancer of the Esophagus or Gastroesophageal Junction |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
CAPRELSA FDA Label Details
Indications & Usage
FDA Label (PDF)CAPRELSA is indicated for the treatment of Medullary Thyroid Cancer.
WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypoca...
CAPRELSA Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for CAPRELSA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 4 active patents
Trial Analysis
- • 34 total trials
- • Stage: Declining
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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