Drug

Tofogliflozin anhydrous

As of the edition of 20 October 2026, Tofogliflozin anhydrous is a small molecule: marketed, first approved in 2014 (JP); acts on SLC5A2.

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

The drug

Status
Marketed; latest approval 2014
Kind
Small molecule
Brand name
Apleway
First approved
24 March 2014 (JP)
Approvals on record
2 in 1 region
Holder of the most recent approval
Sanofi; 2 holders in all
Registered trials
10, 0 stopped early
Disease areas
Hormones; Nutrition and metabolism; Digestive system

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Tofogliflozin anhydrous.

Target

GeneProteinUniProt
SLC5A2Sodium/glucose cotransporter 2P31639

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 15500
Phase 23210
Phase 42200
All trials10

Who has held its approvals

CompanyRoleYears
KowaApplicant and Lead sponsor of trials2014 to now
SanofiApplicant and Lead sponsor of trials2014 to now