Drug

Picosulfuric acid

As of the edition of 20 October 2026, Picosulfuric acid is a small molecule: marketed, first approved in 1968 (ES).

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

The drug

Status
Marketed; latest approval 2016
Kind
Small molecule
Brand name
Prepopik
First approved
1 May 1968 (ES)
Approvals on record
6 in 5 regions
Holder of the most recent approval
Ferring Pharmaceuticals; 3 holders in all
Registered trials
27, 1 stopped early
Disease areas
Digestive system; Cancer; Infections; Injuries; Mental health; Nutrition and metabolism

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.

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated6300
Phase 12110
Phase 23120
Phase 36600
Phase 410511
All trials27

Who has held its approvals

CompanyRoleYears
Ferring PharmaceuticalsApplicant and Lead sponsor of trials2004 to now