Drug · Small Molecule

Vandetanib

CI-DRUG-00000632Explore in graph →NCIt C2737 CHEMBL24828 CIViC Approved

Regulatory

Approvals (6)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory6 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as CAPRELSA (DIN 02378582) under ATC L01EX04 VANDETANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 23, 2012	health-canada-dpd
CA Health Canada	—	Marketed in Canada as CAPRELSA (DIN 02378590) under ATC L01EX04 VANDETANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 23, 2012	health-canada-dpd
EU EMA	Thyroid Gland Medullary Carcinoma	Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is indicated in adults, children and adolescents aged 5 years and older. For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 14 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	3	1	9	97	6	CA, EU, US	Apr 6, 2011	2002-05
Malignant Thyroid Gland Neoplasm	Approved	Phase 4	2	1	4	12	2	EU, US	Apr 6, 2011	2004-11
Malignant Lung Neoplasm	Phase3	Phase 3	0	0	4	24	0	—	—	2002-10
Malignant Breast Neoplasm	Phase2	Phase 2	1	0	0	7	0

Curated evidence

Clinical evidence (10)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–10 of 10 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
SDHB Mutation1
Metformin + Vandetanib

Clinical trials

Trials with this intervention (99)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 99 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT01582191	Vandetanib and Everolimus in Treating Patients With Advanced or Metastatic Cancer	completed	Phase 1	123	M.D. Anderson Cancer CenterOTHER	1	Aug 28, 2026	clinicaltrials
NCT01298323	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

Molecule

Record

Kind: Small Molecule
Mechanism: Tyrosine-protein kinase SRC inhibitor; Tyrosine-protein kinase BRK inhibitor; Tyrosine-protein kinase TIE-2 inhibitor; Vascular endothelial growth factor receptor inhibitor; Tyrosine-protein kinase receptor RET inhibitor; Ephrin receptor inhibitor; Epidermal growth factor receptor inhibitor
Targets: 25 genes
UNII: YO460OQ37K
Aliases: AZD 6474, AZD6474, Caprelsa, GNF-PF-2188, Lucivand, NSC-744325, NSC-760766, Vandetanib, Zactima, ZD-64, ZD-6474, ZD6474

Data updated 22 hours agoSource updated unknown

Identifiers

Codes (7)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EX04	VANDETANIB
ATC (WHO)	L01XE	Antineoplastic and immunomodulating agents

RET Fusion2
Everolimus + VandetanibCombination	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID1622 Case report of a 74-year old woman with EGFR- and ALK-negative lung adenocarcinoma. FISH identified a deletion of 5'RET (FISH, indicating RET-gene rearrangement) and genomic testing confirmed a fusion… (full text at CIViC) PMID 25982012 · Subbiah et al., 2015 · Open in CIViC	civic
Vandetanib	Lung Adenocarcinoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID698 A case study of a patient with EGFR, KRAS, BRAF, HER2, ALK, ROS1 and MET negative adenocarcinoma of the lung. FISH analysis revealed a KIF5B-RET fusion. The RET inhibitor Vandetanib led to remission i… (full text at CIViC) PMID 23584301 · Gautschi et al., 2013 · Open in CIViC	civic

RET Fusion2
Vandetanib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID4848 RET rearrangements involving RET are found in about 1% of NSCLC and define a unique molecular subset. This study was a multi-center, open-label, phase II clinical trial to examine the safety and effi… (full text at CIViC) PMID 27803005 · Lee et al., 2017 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID4849 We aimed to assess the efficacy and safety of vandetanib in patients with advanced RET-rearranged NSCLC. In this open-label, multicentre, phase 2 trial (LURET), patients with advanced RET-rearranged N… (full text at CIViC) PMID 27825616 · Yoh et al., 2017 · Open in CIViC	civic

RET Overexpression2
Vandetanib	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	2	accepted	EID740 Vandetanib was tested in 4 murine models of patient-derived xenografts. In xenografts with high expression of EGFR or RET, vandetanib led to tumor regression, in those without high expression, vandeta… (full text at CIViC) PMID 26686064 · Hatem et al., 2016 · Open in CIViC	civic
〃	Estrogen Receptor-negative Breast CancerUNRESOLVED	Predictive	D	Supports Sensitivity Response	3	submitted	EID2992 The activity of Vandetanib was tested in vivo in three PDX models of TNBC and one model of HER2+ BC with different expression levels of RET and EGFR. Vandetanib induced tumor regression in PDX models … (full text at CIViC) PMID 26686064 · Hatem et al., 2016 · Open in CIViC	civic