Lactulose
As of the edition of 20 October 2026, Lactulose 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 2018
- Kind
- Small molecule
- Brand name
- Cephulac
- First approved
- 1 May 1968 (ES)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- Sanwa Kagaku Kenkyusho; 6 holders in all
- Registered trials
- 64, 5 stopped early
- Disease areas
- Digestive system; Nutrition and metabolism; Nervous system; Infections; Pregnancy and women's health; Urinary and reproductive
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
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 22 | 10 | 6 | 1 |
| Phase 1 | 5 | 4 | 1 | 0 |
| Phase 2 | 9 | 5 | 2 | 0 |
| Phase 3 | 11 | 6 | 1 | 2 |
| Phase 4 | 17 | 9 | 2 | 2 |
| All trials | 64 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Solvay Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2002 to now |
| Sanwa Kagaku Kenkyusho | Applicant | 2018 to now |
| Hikma Pharmaceuticals | Later holder | |
| Sanofi | Applicant |