Drugs / Relugolix
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ORGOVYX | — | 2024-10-18 | fda.gov ↗ |
| Approved | EU (EMA) | Ryeqo | — | 2021-07-16 | europa.eu ↗ |
| Approved | US (FDA) | ORGOVYX | — | 2020-12-18 | fda.gov ↗ |
Trials 52 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT06130995 | Dec 2024 → Jan 2029 expected | — | University of Oklahoma | Recruiting | No outcome recorded |
| Phase 1 | NCT06631521 | Oct 2024 → Jun 2026 overdue | prostate adenocarcinoma | AdventHealth | Recruiting | No outcome recorded |
| Phase 1 | NCT05679388 | Feb 2023 → Aug 2024 | prostate adenocarcinoma | University of Chicago | Terminated | No outcome recorded |
| Phase 1 | NCT04666129 | Feb 2021 → May 2024 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04714554 | Jan → Mar 2021 | — | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 1 | NCT02792062 | Jul → Aug 2016 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT04978688 | Jun → Sep 2016 | — | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 1 | NCT02396147 | Mar → Apr 2015 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02252354 | Sep → Oct 2014 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02141659 | May 2014 → Apr 2017 | prostate carcinoma | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT02093390 | Mar → Apr 2014 | endometriosis, prostate cancer | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 220 trials | ||||||
| Phase 2 | NCT07455903 | Apr 2026 → Oct 2029 expected | prostate carcinoma | Baptist Health South Florida | Recruiting | No outcome recorded |
| Phase 2 | NCT07302451 | Dec 2025 → May 2027 expected | prostate adenocarcinoma | National Cancer Institute, Naples | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07216248 | Oct 2025 → Oct 2030 expected | metastatic prostate carcinoma | University of Utah | Recruiting | No outcome recorded |
| Phase 2 | NCT07025369 | Aug 2025 → Dec 2026 expected | prostate adenocarcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT06463457 | Dec 2024 → Nov 2028 expected | prostate cancer | Atish Choudhury, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06111313 | Nov 2024 → Nov 2028 expected | prostate cancer | University of Miami | Recruiting | No outcome recorded |
| Phase 2 | NCT06499870 | Sep 2024 → Nov 2030 expected | prostate adenocarcinoma | Sean Sachdev | Recruiting | No outcome recorded |
| Phase 2 | NCT06330805 | Aug 2024 → Dec 2027 expected | prostate adenocarcinoma | Ohio State University Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06279195 | Jun 2024 → Nov 2025 | pelvis syndrome | Endeavor Health | Withdrawn | No outcome recorded |
| Phase 2 | NCT06397703 | Apr 2024 → Apr 2030 expected | prostate cancer | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT05765500 | Feb 2024 → Jul 2027 expected | prostate cancer | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06129851 | Nov 2023 → Oct 2025 overdue | prostate cancer | University of Kansas Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05320406 | Jun 2022 → Jan 2025 overdue | prostate carcinoma | Emory University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05053152 | Apr 2022 → Feb 2029 expected | metastatic prostate carcinoma, prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04523207 | Aug 2020 → Oct 2023 | prostate cancer | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02135445 | Jun 2014 → Dec 2015 | prostate cancer | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02083185 | Mar 2014 → Jan 2016 | prostate cancer | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01452685 | Mar 2012 → Dec 2013 | endometriosis | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT01452659 | Oct 2011 → Sep 2012 | leiomyoma | Takeda | Completed | No outcome recorded |
| Phase 2 | NCT01458301 | Oct 2011 → Aug 2013 | endometriosis | Takeda | Completed | No outcome recorded |
| Phase 317 trials | ||||||
| Phase 3 | NCT07100782 | Dec 2025 → Aug 2028 expected | endometriosis, pelvis syndrome | University of Michigan | Recruiting | No outcome recorded |
| Phase 3 | NCT06650579 | Jan 2025 → Jul 2029 expected | prostate carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 3 | NCT06671548 | Jan 2024 → Nov 2026 expected | leiomyoma | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05862272 | Aug 2023 → Jul 2029 expected | endometriosis, leiomyoma | Sumitomo Pharma Switzerland GmbH | Recruiting | No outcome recorded |
| Phase 3 | NCT05605964 | Jan 2023 → Dec 2024 | prostate cancer | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04756037 | Mar 2021 → Feb 2025 | — | Sumitomo Pharma Switzerland GmbH | Completed | No outcome recorded |
| Phase 3 | NCT03931915 | May 2019 → Jun 2020 | endometriosis | ASKA Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03751124 | Oct 2018 → Feb 2021 | uterine corpus leiomyoma | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT03654274 | May 2018 → Dec 2021 | endometriosis | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT03204318 | Dec 2017 → Jun 2020 | endometriosis | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT03204331 | Nov 2017 → Apr 2020 | endometriosis | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT03412890 | Oct 2017 → Jan 2020 | leiomyoma | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT03103087 | Jun 2017 → Jul 2019 | leiomyoma | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT03049735 | Apr 2017 → Apr 2019 | leiomyoma | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT03085095 | Apr 2017 → Oct 2019 | prostate cancer | Myovant Sciences GmbH | Completed | No outcome recorded |
| Phase 3 | NCT02655224 | Mar 2016 → May 2017 | leiomyoma | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02655237 | Mar 2016 → May 2017 | benign neoplasm of corpus uteri | Takeda | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07111247 | Jan 2026 → Aug 2027 expected | — | Oregon Health and Science University | Recruiting | No outcome recorded |
| Phase 4 | NCT05538689 | Nov 2022 → Oct 2024 | leiomyoma, menstrual disorder | University of Chicago | Withdrawn | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07173127 | Sep 2025 → Dec 2026 expected | uterine benign neoplasm | University Hospital, Geneva | Recruiting | No outcome recorded |
| — | NCT05746806 | Mar 2023 → Nov 2027 expected | prostate carcinoma | Insel Gruppe AG, University Hospital Bern | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 19 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07069465 Comparator | Jun → Nov 2024 | prostate cancer | Urology Clinics of North Texas | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT06531499 Background | Nov 2024 → Nov 2028 expected | prostate carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT06379217 Background | Jul 2024 → Aug 2026 overdue | prostate neuroendocrine neoplasm | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06312761 Background | Jun 2024 → Dec 2025 | hypogonadism, male | University of Washington | Unknown | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT07142551 Background | Mar 2026 → Jun 2030 expected | castration-resistant prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT06922318 Background | Aug 2025 → Aug 2031 expected | castration-resistant prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT06528210 Background | Apr 2025 → Jun 2026 | prostate adenocarcinoma | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 2 | NCT06734130 Background | Jan 2025 → Jan 2029 expected | metastatic prostate carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06378866 Comparator | Jun 2024 → Feb 2031 expected | castration-resistant prostate carcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT06111781 Comparator | Apr 2024 → Feb 2028 expected | prostate cancer | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT06059118 Background | Oct 2023 → Jan 2027 expected | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT05189457 Background | Jan 2022 → Jul 2027 expected | prostate cancer | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04787744 Background | Jul 2021 → Sep 2026 expected | metastatic prostate carcinoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06439524 Comparator | Aug 2024 → Jun 2028 expected | endometriosis | Main Line Health | Recruiting | No outcome recorded |
| Phase 3 | NCT05050084 Background | Dec 2021 → Nov 2026 expected | prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04513717 Background | Jan 2021 → Dec 2033 expected | prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04423211 Background | Oct 2020 → Dec 2032 expected | metastatic prostate carcinoma, prostate adenocarcinoma | ECOG-ACRIN Cancer Research Group | Recruiting | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07142967 Background | Aug 2025 → Aug 2028 expected | prostate cancer | NYU Langone Health | Recruiting | No outcome recorded |
| — | NCT05628363 Background | Jan 2023 → Oct 2025 overdue | prostate cancer | Washington University School of Medicine | Active not recruiting | No outcome recorded |
Press releases naming this drug 10 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-06-17 | Pfizer | Myovant Sciences and Pfizer Announce Publication in The Lancet of Phase 3 SPIRIT 1 and SPIRIT 2 Studies of Once-Daily Relugolix Combination Therapy in Women With Endometriosis-Associated Pain pfizer.com ↗ |
| 2021-10-19 | Pfizer | Myovant Sciences and Pfizer Present Data on Relugolix Combination Therapy from Studies in Uterine Fibroids and Endometriosis at the American Society for Reproductive Medicine Congress pfizer.com ↗ |
| 2021-04-12 | Pfizer | Myovant Sciences and Pfizer Announce First Participant Dosed in Phase 3 SERENE Study Evaluating Contraceptive Efficacy of Once-Daily Relugolix Combination Tablet pfizer.com ↗ |
| 2021-03-24 | Pfizer | Myovant Sciences and Pfizer Announce Positive Data from Phase 3 LIBERTY Randomized Withdrawal Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids pfizer.com ↗ |
| 2021-02-17 | Pfizer | Myovant Sciences and Pfizer Announce Publication in the New England Journal of Medicine of Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids pfizer.com ↗ |
| 2021-01-26 | Pfizer | Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination Therapy in Women with Endometriosis pfizer.com ↗ |
| 2020-12-28 | Pfizer | Myovant Sciences and Pfizer Announce Collaboration to Develop and Commercialize Relugolix in Oncology and Women's Health pfizer.com ↗ |
| 2018-05-31 | Takeda | ASKA and Takeda Enter into Licensing Agreement for Relugolix in Women's Health Indications takeda.com ↗ |
| 2017-11-09 | Takeda | Takeda Announces Positive Results from its Phase 3 Clinical Trial in Japan Evaluating the Efficacy and Safety of Relugolix in the Treatment of Pain Symptoms Associated with Uterine Fibroids takeda.com ↗ |
| 2017-10-03 | Takeda | Takeda Announces Positive Results from its Phase 3 Confirmatory Clinical Trial in Japan Evaluating the Efficacy and Safety of GnRH Receptor Antagonist Relugolix in Uterine Fibroids takeda.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 73 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | relugolix | “Patients will continue on ADT with LHRH agonist (i.e. Zoladex, Trelstar, Eligard, or Lupron) or LHRH antagonist (Degarelix or Relugolix) if not surgically castrated throughout...” NCT06922318 ↗60“Ryeqo® consists of an oral treatment, available as a pill, which contains 40 mg of the GnRH antagonist Relugolix, combined with 1 mg of oestradiol and a progestin, such as...” NCT07173127 ↗ “The aim of this study was to evaluate the efficacy and safety of three dose levels of oral relugolix, a small molecule GnRH receptor antagonist, in Japanese women with uterine...” PMID 34711224 ↗ Oct 2021 “luteinizing hormone-releasing hormone (LHRH) agonist (i.e. Zoladex, Trelstar, Eligard, or Lupron) or LHRH antagonist (Degarelix or Relugolix)” NCT06059118 ↗ “Each tablet of Myfembree contains Relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5 mg.” NCT05538689 ↗ “ADT will be administered via Leuprolide or Degarelix monthly injections or daily Relugolix pills.” NCT07142967 ↗ “ADT is defined as a GnRH agonist/antagonist (leuprolide, goserelin, degarelix, or relugolix).” NCT05628363 ↗ “GNRH agonist (leuprolide, goserelin, triptorelin) or GNRH antagonist (relugolix, degarelix)” NCT06528210 ↗ “abarelix, degarelix, or relugolix” NCT06379217 ↗ “Degarelix, Relugolix” NCT06531499 ↗ “Relugolix” NCT06734130 ↗ “Relugolix” NCT05189457 ↗ |
| Known as | [14C]-TAK-385 | “[14C]-TAK-385 Oral Solution” NCT02252354 ↗ |
| Known as | Orgovyx | “e.g. Orgovyx® Tablets 120mg; first day 360mg, after second day 120mg per day” NCT05746806 ↗2“LHRH agonist or antagonist (e.g. Eligard, Zoladex, Lupron, Orgovyx)” NCT07142551 ↗ “Relugolix 120 MG [Orgovyx]” NCT06111781 ↗ |
| Known as | Relugolix component of myfembree | ChEMBL registry synonym — accepted as the source's own label CHEMBL1800159 ↗ |
| Known as | TAK-385 | “The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with endometriosis.” NCT01458301 ↗10“The drug being tested in this study is called relugolix (TAK-385).” NCT02083185 ↗ “TAK-385 40 mg tablets + Leuprorelin acetate placebo injection” NCT03931915 ↗ |
| Action | Inhibit | “Gonadotropin-releasing hormone receptor antagonist” CHEMBL1800159 ↗1“a small molecule GnRH receptor antagonist” PMID 34711224 ↗ Oct 2021 |
| Modality | Small molecule | “a small molecule GnRH receptor antagonist” PMID 34711224 ↗ Oct 2021 |
| Route | Oral | “Patients were randomized 1:1:1:1 to relugolix 10, 20, or 40 mg, or placebo, orally once daily for 12 weeks.” PMID 34711224 ↗ Oct 2021 |
| Target | GNRHR | “Gonadotropin-releasing hormone receptor antagonist” CHEMBL1800159 ↗ |