Pipeline

Our lead investigational drug candidate is relugolix, a small molecule, GnRH receptor antagonist. We have three clinical programs for relugolix consisting of five international Phase 3 clinical trials, two in women with heavy menstrual bleeding associated with uterine fibroids (LIBERTY 1 & 2), two in women with endometriosis-associated pain (SPIRIT 1 & 2), and one in men with advanced prostate cancer (HERO).

We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, as a potential treatment for women undergoing assisted reproduction, such as in vitro fertilization (IVF). In a Phase 2a trial, we are assessing the exposure-response profile of MVT-602 during the pre-ovulatory phase in women undergoing controlled ovarian stimulation.

Myovant Development

Relugolix
Preclinical
Phase 1
Phase 2
Phase 3
Filed
Approved

Symptoms of Uterine Fibroids
Combination Therapy

Combination Therapy:
Relugolix 40 mg + estradiol 1 mg and norethindrone acetate 0.5 mg
Projected Upcoming Data Release:
Top-line results in Q3 2019
Expected NDA Filing:
2019
Note:
Open-label extension and randomized withdrawal study to evaluate longer-term treatment

Symptoms of Endometriosis
Combination Therapy

Combination Therapy:
Relugolix 40 mg + estradiol 1 mg and norethindrone acetate 0.5 mg
Projected Upcoming Data Release:
Top-line results in Q1 2020
Note:
Open-label extension study to evaluate longer-term treatment

Advanced Prostate Cancer
Monotherapy

Monotherapy:
Relugolix 120 mg once daily following a single 360 mg loading dose
Projected Upcoming Data Release:
Top-line results in Q4 2019
Expected NDA Filing:
2020
Note:
Key secondary endpoint is delay time to the onset of castration-resistance
MVT-602
Preclinical
Phase 1
Phase 2
Phase 3
Filed
Approved

Female Infertility as Part of Assisted Reproduction

Projected Upcoming Data Release:
1H 2019

Japanese Development

Relugolix
Preclinical
Phase 1
Phase 2
Phase 3
Filed
Approved

Symptoms of Uterine Fibroids
Monotherapy

Monotherapy:
Relugolix 40 mg
Brand Name:
Relumina®
Approved Indication:
Improvement of symptoms of uterine fibroids (heavy menstrual bleeding, lower abdominal pain, lower back pain, anemia)
Note:
ASKA Pharmaceutical has exclusive commercialization rights in Japan and certain other Asian countries

Symptoms of Endometriosis
Monotherapy

Monotherapy:
Relugolix 40 mg
Note:
ASKA Pharmaceutical has exclusive development and commercialization rights in Japan and certain other Asian countries

Learn More About Our Clinical Trials

We cannot achieve our mission to transform women’s health and prostate cancer without clinical trials. All across the world, patients, families, physicians, and clinics support our clinical trials as we strive to turn our purpose-driven science into empowering medicines.

View clinical trials