Methotrexate
As of the edition of 20 October 2026, Methotrexate is a small molecule: marketed, first approved in 1965 (ES); acts on DHFR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Otrexup
- First approved
- 1 April 1965 (ES)
- Approvals on record
- 69 in 6 regions
- Holder of the most recent approval
- Pfizer; 17 holders in all
- Registered trials
- 1,223, 160 stopped early
- Disease areas
- Immune system; Cancer; Blood and lymph; Skin and connective tissue; Bones, joints and muscles; Infections
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.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Methotrexate.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| DHFR | Dihydrofolate reductase | P00374 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 121 | 65 | 17 | 11 |
| Phase 1 | 119 | 76 | 23 | 14 |
| Phase 2 | 549 | 290 | 93 | 101 |
| Phase 3 | 296 | 200 | 36 | 20 |
| Phase 4 | 138 | 83 | 13 | 14 |
| All trials | 1,223 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant, Acquired holder, Later holder and Lead sponsor of trials | 1997 to now |
| Halozyme Therapeutics | Later holder and Lead sponsor of trials | 2011 to now |
| medac | Later holder and Lead sponsor of trials | 2012 to now |
| Nordic | Applicant and Acquired holder | 2016 to now |
| Oresund Pharma ApS | Later holder | 2017 to now |
| Medexus Pharma | Acquired holder | 2019 to now |
| Cumberland Pharmaceuticals | Later holder | 2019 to now |
| Accord Healthcare | Later holder | 2020 to now |
| Azurity Pharmaceuticals | Acquired holder | 2020 to now |
| Shorla Pharma | Acquired holder | 2023 to now |
| Strides Pharma | Acquired holder | 2025 to now |
| Cosette Pharmaceuticals | Acquired holder | 2026 to now |
| Santen Pharmaceutical | Later holder | |
| Sawai Pharmaceutical | Later holder |