What development phase is TOLRESTAT in?

TOLRESTAT is FDA-approved (marketed).

Last reviewed 2026-04-20 · How we verify

TOLRESTAT

FDA-approved withdrawn Small molecule Quality 1/100

Tolrestat is a marketed drug with a key composition patent expiring in 2028. The drug's market position and primary indication are not specified, but it maintains a foothold in its therapeutic area. The primary risk is the patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Generic name	TOLRESTAT
Modality	Small molecule
Phase	FDA-approved
First approval	1989

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
FDA label	Mechanism, indications, dosing, boxed warnings, drug interactions

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

TOLRESTAT CI brief — competitive landscape report
TOLRESTAT updates RSS · CI watch RSS