Pipeline

Our lead investigational drug candidate is relugolix, a small molecule, GnRH receptor antagonist. We have three clinical programs for relugolix which consisted 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 trigger of egg maturation in women undergoing assisted reproduction, including in vitro fertilization (IVF).

Myovant Development

Relugolix
Preclinical
Phase 1
Phase 2
Phase 3
Submitted
Approved

Symptoms of Uterine Fibroids

Combination Therapy

Combination Therapy:
Relugolix 40 mg + estradiol 1.0 mg and norethindrone acetate 0.5 mg
Projected Upcoming Data Release:
Randomized withdrawal study in Q1 2021.
Note:
MAA submitted in March 2020. NDA under review with a FDA target action date of June 1, 2021.

Symptoms of Endometriosis

Combination Therapy

Combination Therapy:
Relugolix 40 mg + estradiol 1.0 mg and norethindrone acetate 0.5 mg
Projected Upcoming Data Release:
Long-term extension study in Q1 2021.
Note:
Positive data from replicate Phase 3 studies reported in April and June 2020.

Advanced Prostate Cancer

Monotherapy

Monotherapy:
Relugolix 120 mg once daily following a single 360 mg loading dose
Note:
NDA under Priority Review with a FDA target action date of December 20, 2020.
MVT-602
Preclinical
Phase 1
Phase 2
Phase 3
Submitted
Approved

Female Infertility as Part of Assisted Reproduction

Japanese Development

Learn more about our clinical trials

We cannot achieve our mission to redefine care for women and for men without clinical trials. All across the world, patients, families, physicians, and clinics support these trials as we strive to turn our purpose-driven science into empowering medicines.

View clinical trials