Drug

Cipepofol

As of the edition of 20 October 2026, Cipepofol is a small molecule: marketed, first approved in 2026 (US); 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
Cypsedo
First approved
27 August 2026 (US)
Approvals on record
1 in 1 region
Holder of the most recent approval
Haisco-USA Pharmaceuticals
Registered trials
81, 1 stopped early
Disease areas
Digestive system; Heart and blood vessels; Nervous system; Cancer; Lungs and airways; Mental health

US protection

US protection ends in 2031.

The last listed US exclusivity ends in 2031. The application that gives this date is held by Haisco-USA Pharmaceuticals.

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

1 listing counts towards this date. The exact date and each listing are in the product.

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Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated23380
Phase 1171401
Phase 26600
Phase 3111010
Phase 4248110
All trials81

Who has held its approvals

CompanyRoleYears
Haisco-USA PharmaceuticalsOriginator and Lead sponsor of trials2021 to now