Wednesday, July 8, 2026

Drug profile · INN

lactulose

lactulose (ACILAC) is a colonic bacteria substrate. Associated with Teva Pharma GmbH. Route of administration: oral, rectal. Current US regulatory status: approved.

FDA: approved NMPA: clinical trials
US status approved
Patents linked 2
Pipeline programs 6
News articles 0
Drug details — lactulose
US status
approved
Class
Route
ORAL, RECTAL
Patents
2
Programs
6
Data quality
0.89

Quick answer

lactulose (ACILAC) is a colonic bacteria substrate. Associated with Teva Pharma GmbH. Route of administration: oral, rectal. Current US regulatory status: approved.

Key facts

INN lactulose
Brand ACILAC
Mechanism Colonic bacteria substrate
Route ORAL, RECTAL
Formulation SOLUTION

Mechanism of action

Colonic bacteria substrate

Approval history

Authority Status Date
FDA approved
NMPA clinical trials

Pipeline programs

  1. 90 grams of Crystalline Lactulose Phase 2 · Cumberland Pharmaceuticals · Colonoscopy Preparation
  2. Crystalline Lactulose Phase 2 · Cumberland Pharmaceuticals · Colonoscopy
  3. Lactulose Phase 2 · Chinese Academy of · Constipation
  4. lactulose Phase 2 · Ultragenyx UK · Portal Hypertension
  5. lactulose (Kristalose®) Approved · Cumberland Pharmaceuticals · Constipation
  6. Lactulose Unknown · First People's Hospital · Colon Disease
  1. US 9375441

    Lactulose for bowel evacuation

    Expires Mon Jun 23 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 8778907

    Lactulose for bowel evacuation

    Expires Mon Jul 10 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is lactulose?

lactulose (ACILAC) is a colonic bacteria substrate. Associated with Teva Pharma GmbH. Route of administration: oral, rectal. Current US regulatory status: approved.

What is the brand name for lactulose?

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

What is the US approval status of lactulose?

lactulose 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.