13 completed, 2 not yet recruiting, 2 terminated, 1 active not recruiting. 9 Phase 3, 5 Phase 2, 2 Phase 1, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Completed 6, Terminated 2, Active not recruiting 1 |
| Phase 2 | 5 | Completed 5 |
| Phase 1 | 2 | Completed 2 |
| Not applicable | 1 | Not yet recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Linzagolix in Adenomyosis and Recurrent Implantation Failure Linzagolix 200 mg (Yselty) - Adenomyosis of Uterus, Implantation Failure | Not yet recruiting | Vida Fertility Institute | 30 | 2027-01-01 | 2026-10-21 | |
| Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS) Ganirelix ; Cetrorelix, Medroxyprogesterone Acetate ; Micronized Progesterone, Linzagolix - Infertility, Female, Ovulation Induction | Not applicable | Not yet recruiting | Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita) | 120 | 2026-09-01 | 2026-09-30 |
| A Clinical Study of KLH-2109 in Patients With Endometriosis KLH-2109, Leuprorelin acetate - Endometriosis | Phase 3 | Active not recruiting | Kissei Pharmaceutical Co., Ltd. | 288 | 2025-06-09 | 2026-03-02 |
| A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain KLH-2109, Placebo - Uterine Fibroids (MeSH Heading: Leiomyoma) | Phase 3 | Completed | Kissei Pharmaceutical Co., Ltd. | 89 | 2022-10-11 | 2025-11-25 |
| A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia KLH-2109, Leuprorelin - Uterine Fibroids (MeSH Heading: Leiomyoma) | Phase 3 | Completed | Kissei Pharmaceutical Co., Ltd. | 287 | 2022-10-11 | 2025-03-14 |
| Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain 75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg) - Endometriosis | Phase 3 | Terminated | Kissei Pharmaceutical Co., Ltd. | 30 | 2020-03-23 | 2025-04-02 |
| Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6) 75 mg linzagolix tablet, 200 mg linzagolix tablet, Placebo tablet to match 75 mg linzagolix tablet - Endometriosis | Phase 3 | Completed | Kissei Pharmaceutical Co., Ltd. | 356 | 2020-03-05 | 2025-04-02 |
| Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain. 75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg) - Endometriosis | Phase 3 | Completed | Kissei Pharmaceutical Co., Ltd. | 486 | 2019-06-13 | 2025-04-02 |
| A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain 75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg) - Endometriosis | Phase 3 | Terminated | Kissei Pharmaceutical Co., Ltd. | 85 | 2019-05-23 | 2025-04-02 |
| Safety and Pharmacokinetics of Linzagolix in Female Subjects With Normal and Impaired Renal Function Linzagolix - Renal Impairment, Healthy Participants | Phase 1 | Completed | ObsEva SA | 33 | 2019-05-15 | 2020-03-05 |
| Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function Linzagolix - Hepatic Impairment, Healthy Participants | Phase 1 | Completed | ObsEva SA | 24 | 2019-05-15 | 2020-01-13 |
| Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids OBE2109, Placebo to match OBE2109, Placebo to match Add-back - Uterine Fibroids, Heavy Menstrual Bleeding | Phase 3 | Completed | ObsEva SA | 511 | 2017-05-23 | 2021-03-05 |
| Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids OBE2109, Placebo to match OBE2109, Placebo to match Add-back - Uterine Fibroids, Heavy Menstrual Bleeding | Phase 3 | Completed | ObsEva SA | 526 | 2017-04-20 | 2021-06-09 |
| A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis Placebo, OBE2109 - Endometriosis | Phase 2 | Completed | ObsEva SA | 328 | 2016-07-01 | 2022-07-21 |
| Late Phase II Clinical Study of KLH-2109 in Patients With Endometriosis KLH-2109, Placebo, Leuprorelin acetate - Endometriosis | Phase 2 | Completed | Kissei Pharmaceutical Co., Ltd. | 2016-05-09 | 2019-06-04 | |
| A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1) KLH-2109 - Endometriosis | Phase 2 | Completed | Kissei Pharmaceutical Co., Ltd. | 20 | 2013-10-30 | |
| A Randomized, Placebo-controlled, Double-blind Study of KLH-2109 in Patients With Endometriosis (2) KLH-2109, placebo - Endometriosis | Phase 2 | Completed | Kissei Pharmaceutical Co., Ltd. | 100 | 2014-05-30 | |
| A Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis KLH-2109 - Endometriosis | Phase 2 | Completed | Kissei Pharmaceutical Co., Ltd. | 20 | 2014-05-30 |
Endometriosis (10) · Dysmenorrhea (5) · Dyspareunia (5) · Constipation (4) · Leiomyoma (4) · Infertility, Female (2) · Menorrhagia (2) · Adenomyosis (1) · Hepatic Insufficiency (1) · Kidney Diseases (1) · Liver Diseases (1) · Pelvic Pain (1) · Renal Insufficiency (1)
Kissei Pharmaceutical Co., Ltd. (11) · ObsEva SA (5) · Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita) (1) · Vida Fertility Institute (1)
United States (9) · Japan (7) · Poland (4) · Ukraine (4) · Bulgaria (3) · Czechia (3) · Romania (3) · Spain (3) · Austria (2) · Canada (2) · France (2) · Hungary (2) · Puerto Rico (2) · Latvia (1) · Lithuania (1)
ObsEva SA (5) · Yoshitaka Shimizu (3) · Katsumi Hontani (1) · Tatsuro Takei (1)
PMID 36116480, PMID 40326221, PMID 40543832, PMID 32505383, PMID 38648863, PMID 42077502, PMID 42406777