Esketamine
As of the edition of 20 October 2026, Esketamine is a small molecule: marketed, first approved in 2019 (US); acts on GRIN1, GRIN2A and GRIN2B and 4 more; US protection ends in 2028.
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
- Spravato
- First approved
- 5 March 2019 (US)
- Approvals on record
- 5 in 5 regions
- Holder of the most recent approval
- LABORATOIRE RENAUDIN; 4 holders in all
- Registered trials
- 254, 12 stopped early
- Disease areas
- Mental health; Nervous system; Pregnancy and women's health; Urinary and reproductive; Cancer; Digestive system
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Johnson & Johnson.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
5 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product5 company-target rows are on route B because of Esketamine.
See the 5 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| GRIN2D | Glutamate receptor ionotropic, NMDA 2D | O15399 |
| GRIN3B | Glutamate receptor ionotropic, NMDA 3B | O60391 |
| GRIN1 | Glutamate receptor ionotropic, NMDA 1 | Q05586 |
| GRIN2A | Glutamate receptor ionotropic, NMDA 2A | Q12879 |
| GRIN2B | Glutamate receptor ionotropic, NMDA 2B | Q13224 |
| GRIN2C | Glutamate receptor ionotropic, NMDA 2C | Q14957 |
| GRIN3A | Glutamate receptor ionotropic, NMDA 3A | Q8TCU5 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 95 | 27 | 38 | 3 |
| Phase 1 | 39 | 30 | 2 | 1 |
| Phase 2 | 16 | 12 | 2 | 2 |
| Phase 3 | 31 | 21 | 6 | 3 |
| Phase 4 | 73 | 23 | 27 | 3 |
| All trials | 254 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant and Lead sponsor of trials | 2016 to now |