Relugolix
As of the edition of 20 October 2026, Relugolix is a small molecule: marketed, first approved in 2019 (JP); acts on GNRHR; US protection ends in 2033.
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
- Orgovyx
- First approved
- 8 January 2019 (JP)
- Approvals on record
- 7 in 3 regions
- Holder of the most recent approval
- Accord Healthcare; 5 holders in all
- Registered trials
- 54, 3 stopped early
- Disease areas
- Urinary and reproductive; Cancer; Pregnancy and women's health; Skin and connective tissue; Hormones; Mental health
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Sumitomo Pharma.
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 product4 listings count 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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Relugolix.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GNRHR | Gonadotropin-releasing hormone receptor | P30968 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 3 | 0 |
| Phase 1 | 10 | 7 | 2 | 1 |
| Phase 2 | 20 | 6 | 12 | 1 |
| Phase 3 | 18 | 12 | 6 | 0 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 54 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Applicant and Lead sponsor of trials | 2011 to now |
| Sumitomo Pharma | Applicant, Acquired holder and Lead sponsor of trials | 2016 to now |
| ASKA Pharmaceutical | Later holder and Lead sponsor of trials | 2019 to now |
| Gedeon Richter | Applicant | 2021 to now |
| Accord Healthcare | Later holder | 2022 to now |