Midazolam
As of the edition of 20 October 2026, Midazolam is a small molecule: marketed, first approved in 1982 (CH); acts on GABRA1, GABRA2 and GABRA3 and 4 more; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Versed
- First approved
- 10 September 1982 (CH)
- Approvals on record
- 27 in 8 regions
- Holder of the most recent approval
- Maruishi Pharmaceutical Co., Ltd.; 18 holders in all
- Registered trials
- 708, 53 stopped early
- Disease areas
- Nervous system; Mental health; Cancer; Infections; Lungs and airways; Skin and connective tissue
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
UCB holds a later exclusivity on its own new formulation or combination product, which ended in 2026; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Midazolam.
See the 1 company-target row on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| GABRA1 | Gamma-aminobutyric acid receptor subunit alpha-1 | P14867 |
| GABRG2 | Gamma-aminobutyric acid receptor subunit gamma-2 | P18507 |
| GABRA5 | Gamma-aminobutyric acid receptor subunit alpha-5 | P31644 |
| GABRA3 | Gamma-aminobutyric acid receptor subunit alpha-3 | P34903 |
| GABRA2 | Gamma-aminobutyric acid receptor subunit alpha-2 | P47869 |
| GABRG1 | Gamma-aminobutyric acid receptor subunit gamma-1 | Q8N1C3 |
| GABRG3 | Gamma-aminobutyric acid receptor subunit gamma-3 | Q99928 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 119 | 74 | 12 | 13 |
| Phase 1 | 398 | 345 | 28 | 18 |
| Phase 2 | 40 | 23 | 9 | 6 |
| Phase 3 | 48 | 24 | 10 | 7 |
| Phase 4 | 103 | 59 | 6 | 9 |
| All trials | 708 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant, Earlier holder and Lead sponsor of trials | 1985 to now |
| Hlr Technology | Acquired holder | 2003 to now |
| Pfizer | Applicant, Later holder and Lead sponsor of trials | 2007 to now |
| Astellas | Later holder and Lead sponsor of trials | 2010 to now |
| UCB | Later holder and Lead sponsor of trials | 2011 to now |
| Neuraxpharm Pharmaceuticals | Applicant | 2011 to now |
| Takeda | Applicant and Lead sponsor of trials | 2013 to now |
| Inforlife | Later holder | 2021 to now |
| Rafa | Later holder and Lead sponsor of trials | 2021 to now |
| Baxter Healthcare | Later holder | 2022 to now |
| Exela Pharma Sciences | Later holder | 2022 to now |