Simethicone
As of the edition of 20 October 2026, Simethicone is a drug: marketed, first approved in 1963 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Unknown
- Brand name
- Imodium Multi-Symptom Relief
- First approved
- 31 December 1963 (CA)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Kenvue Brands; 3 holders in all
- Registered trials
- 25, 1 stopped early
- Disease areas
- Digestive system; Cancer; Ear, nose and throat; 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 | 5 | 4 | 0 | 0 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 2 | 1 | 0 | 0 |
| Phase 3 | 7 | 5 | 0 | 0 |
| Phase 4 | 8 | 6 | 1 | 0 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Church & Dwight | Applicant | 1963 to now |