Drug

Tovorafenib

As of the edition of 20 October 2026, Tovorafenib is a small molecule: marketed, first approved in 2024 (US); acts on ARAF, BRAF and RAF1; US protection ends in 2031.

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

The drug

Status
Marketed; latest approval 2026
Kind
Small molecule
Brand name
Ojemda
First approved
23 April 2024 (US)
Approvals on record
5 in 3 regions
Holder of the most recent approval
Ipsen; 2 holders in all
Registered trials
15, 3 stopped early
Disease areas
Cancer; Skin and connective tissue; Lungs and airways; Blood and lymph; Digestive system; Hormones

US protection

US protection ends in 2031.

The last listed US drug-substance patent ends in 2031. The application that gives this date is held by Servier.

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

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

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Companies that need a new molecule because of this drug

6 company-target rows on route B because of this drug.

Companies on route B for this drug

In the product

6 company-target rows are on route B because of Tovorafenib.

Targets

GeneProteinUniProt
RAF1RAF proto-oncogene serine/threonine-protein kinaseP04049
ARAFSerine/threonine-protein kinase A-RafP10398
BRAFSerine/threonine-protein kinase B-rafP15056

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1000
Phase 17322
Phase 26051
Phase 31010
All trials15

Who has held its approvals

CompanyRoleYears
ServierOriginator and Lead sponsor of trials2022 to now
IpsenApplicant2026 to now