Wednesday, July 8, 2026

Drug profile · INN

lubiprostone

lubiprostone (LUBIPROSTONE) is a chloride channel protein 2 opener. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved NMPA: clinical trials
US status approved
Patents linked 0
Pipeline programs 16
News articles 0
Drug details — lubiprostone
US status
approved
Class
Route
ORAL
Patents
0
Programs
16
Data quality
0.89

Quick answer

lubiprostone (LUBIPROSTONE) is a chloride channel protein 2 opener. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN lubiprostone
Brand LUBIPROSTONE
Mechanism Chloride channel protein 2 opener
Target Chloride channel protein 2
Route ORAL
Formulation CAPSULE

Mechanism of action

Chloride channel protein 2 opener

Primary target: Chloride channel protein 2

Approval history

Authority Status Date
FDA approved
NMPA clinical trials

Pipeline programs

  1. Cohort 1: Lubiprostone Capsule, Fasted Phase 3 · Takeda · Healthy Volunteers
  2. Lubiprostone Phase 3 · Takeda · Constipation - Functional
  3. Lubiprostone Phase 3 · Takeda · Irritable Bowel Syndrome With Constipation
  4. Placebo Phase 3 · Takeda · Chronic Idiopathic Constipation
  5. Lubiprostone Phase 2 · Takeda · Irritable Bowel Syndrome
  6. Lubiprostone Phase 1 · Takeda · Chronic Constipation, Methanogenesis
  7. Lubiprostone Phase 1 · Takeda · Other Constipation
  8. Lubiprostone Approved · Takeda · Inflammatory Bowel Disease

Frequently asked questions

What is lubiprostone?

lubiprostone (LUBIPROSTONE) is a chloride channel protein 2 opener. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for lubiprostone?

LUBIPROSTONE is a marketed brand name for lubiprostone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of lubiprostone?

lubiprostone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.