Drug

Cabozantinib

As of the edition of 20 October 2026, Cabozantinib is a small molecule: marketed, first approved in 2012 (US); acts on KDR; US protection ends in 2032.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2020
Kind
Small molecule
Brand name
Cometriq
First approved
29 November 2012 (US)
Approvals on record
14 in 4 regions
Holder of the most recent approval
Takeda; 3 holders in all
Registered trials
249, 33 stopped early
Disease areas
Cancer; Urinary and reproductive; Pregnancy and women's health; Digestive system; Hormones; Lungs and airways

US protection

US protection ends in 2032.

The last listed US exclusivity ends in 2032. The application that gives this date is held by Exelixis.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

24 listings count towards this date. The exact date and each listing are in the product.

See the exact date and the 24 listings behind itRequest access. Nothing is shown until you do.

Companies that need a new molecule because of this drug

2 companies on route B because of this drug.

Companies on route B for this drug

In the product

2 companies are on route B because of Cabozantinib.

Target

GeneProteinUniProt
KDRVascular endothelial growth factor receptor 2P35968

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated10800
Phase 14626173
Phase 2165576628
Phase 3236142
Phase 45140
All trials249

Who has held its approvals

CompanyRoleYears
ExelixisOriginator and Lead sponsor of trials2012 to now
IpsenApplicant2014 to now
TakedaApplicant and Lead sponsor of trials2017 to now