SHR7280 / Jiangsu Hengrui Pharma - LARVOL DELTA

A Phase 1 Clinical Study to Evaluate the Effects of SHR7280 on the Pharmacokinetics of Midazolam, S-warfarin, Omeprazole, Digoxin, and Rosuvastatin in Healthy Subjects (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Endometriosis • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

A Trial of SHR7280 in Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Endometriosis • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Relative Bioavailability of Single-Dose Oral Administration of Two SHR7280 Formulations (Dry Suspension and Tablets) in Healthy Chinese Volunteers. (PubMed, Clin Drug Investig) - P1 | "The bioavailability of SHR7280 tablets was found to be comparable to that of dry suspension. The safety profile of two formulations was favorable. No serious adverse events or adverse drug reactions were reported."

Journal • Oncology • Ovarian Cancer • Solid Tumor

SHR7280, an oral gonadotropin-releasing hormone antagonist, for the prevention of premature luteinizing hormone surge in controlled ovarian hyperstimulation: a dose-finding, phase 2 trial. (PubMed, Hum Reprod) - P2 | "Findings from this phase 2 trial suggest that an oral GnRH antagonist could be an effective alternative for preventing a premature LH surge in ART."

Journal • P2 data • Gynecology • Infertility

A Trial of SHR7280 in Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Endometriosis • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

A Phase 1 Clinical Study to Evaluate the Effects of SHR7280 on the Pharmacokinetics of Midazolam, S-warfarin, Omeprazole, Digoxin, and Rosuvastatin in Healthy Subjects (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Endometriosis • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Hengrui Medicine sold its innovative molecules to Merck of Germany and reached two external authorizations in half a month (Sina Corp) - "Following the announcement on March 25 that it would license its Lp(a) small molecule inhibitor to Merck and was expected to obtain a transaction value of up to nearly US$2 billion, Hengrui Medicine announced again today that it would license its SHR7280 oral GnRH receptor antagonist project to Merck KGaA (Merck, Germany) for a fee, with the initial payment of 15 million euros....The announcement shows that SHR7280 is a new type of oral small molecule non-peptide GnRH receptor antagonist independently developed by Hengrui Medicine...In this transaction, Merck will obtain the exclusive right to commercialize SHR7280 in mainland China, as well as the priority negotiation right in areas outside the authorized area. In addition to the down payment, Hengrui Medicine will also receive certain milestone payments after the product is approved in China, as well as a double-digit sales commission on the actual annual net sales of the product."

Licensing / partnership • Solid Tumor

Hengrui Medicine: SHR7280 tablets approved for Phase II clinical trial [Google translation] (Eastmoney.com) - "Hengrui Medicine on August 13, the company recently received the 'Drug Clinical Trial Approval Notice' issued by the National Medical Products Administration for SHR7280 tablets, agreeing to conduct Phase II clinical trials of the product. The application is for the reverse addition of Tibolone tablets to SHR7280 tablets for uterine fibroids with menorrhagia. So far, the SHR7280-related projects have invested a total of approximately 174 million yuan in research and development costs."

New P2 trial • Gynecology • Oncology • Solid Tumor • Uterine Leiomyoma • Women's Health

To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects (clinicaltrials.gov) - P3 | N=317 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • Infertility • Sexual Disorders

A Study to Evaluate the Mass Balance of [14C]SHR7280 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Completed

Trial completion

The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis. (clinicaltrials.gov) - P1/2 | N=179 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Jan 2024 ➔ May 2024 | Trial primary completion date: Jan 2024 ➔ May 2024

Trial completion • Trial completion date • Trial primary completion date • Endometriosis • Gynecology • Women's Health

A Study to Evaluate the Mass Balance of [14C]SHR7280 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate the Mass Balance of [14C]SHR7280 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial

Identify Effective Doses of SHR7280 Tablets in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART) (clinicaltrials.gov) - P2 | N=85 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Aug 2023 | Trial primary completion date: Dec 2022 ➔ Aug 2023

Trial completion • Trial completion date • Trial primary completion date

A Clinical Study Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and Tablets (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Endometriosis • Genito-urinary Cancer • Gynecology • Oncology • Prostate Cancer • Solid Tumor • Uterine Leiomyoma • Women's Health

Safety, Pharmacokinetics, and Pharmacodynamics of SHR7280, a Non-peptide GnRH Antagonist in Premenopausal Women with Endometriosis: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. (PubMed, Clin Pharmacokinet) - P1/2 | "SHR7280 showed favorable safety, PK, and PD profiles in the doses of 200 mg QD, 300 mg QD, and 200 mg BID. The results of this study provide evidence to support the further development of SHR7280 as a GnRH antagonist for the treatment of endometriosis-related pain in the subsequent Phase 2 trial."

Clinical • Journal • P1 data • P2 data • PK/PD data • Endometriosis • Gynecology • Pain • Women's Health

To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects (clinicaltrials.gov) - P3 | N=316 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • Infertility • Sexual Disorders

A Phase 1 Dose Escalation and Expansion Study Of SHR7280 In Subjects With Hormone Sensitive Prostate Cancer (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Completed | N=64 ➔ 12 | Trial completion date: Oct 2023 ➔ May 2023 | Trial primary completion date: Oct 2023 ➔ May 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects (clinicaltrials.gov) - P3 | N=316 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Head-to-Head • New P3 trial • Infertility • Sexual Disorders

A Clinical Study Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and Tablets (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Endometriosis • Genito-urinary Cancer • Gynecology • Oncology • Prostate Cancer • Solid Tumor • Uterine Leiomyoma • Women's Health

A Clinical Study Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and Tablets (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Endometriosis • Genito-urinary Cancer • Gynecology • Oncology • Prostate Cancer • Solid Tumor • Uterine Leiomyoma • Women's Health

Safety, pharmacokinetics, and pharmacodynamics of SHR7280, an oral gonadotropin-releasing hormone receptor antagonist, in healthy men: a randomized, double-blind, placebo-controlled phase 1 study. (PubMed, BMC Med) - P1 | "SHR7280 showed an acceptable safety profile, as well as favorable PK and PD profiles within a dose range of 100 to 1000 mg BID. This study proposes a rationale for further investigation of SHR7280 as a potential androgen deprivation therapy."

Clinical • Journal • P1 data • PK/PD data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase II/III Study of Efficacy and Safety of SHR7280 Tablets in Subjects With Menorrhagia With Uterine Fibroids (clinicaltrials.gov) - P2/3 | N=396 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis. (clinicaltrials.gov) - P1/2 | N=207 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Trial completion date: Dec 2022 ➔ Jan 2024 | Trial primary completion date: Dec 2022 ➔ Jan 2024

Trial completion date • Trial primary completion date • Endometriosis • Gynecology • Women's Health

Safety, pharmacokinetics, and pharmacodynamics of SHR7280, an oral gonadotropin-releasing hormone antagonist in healthy premenopausal women. (PubMed, Front Pharmacol) - P1 | "PD results showed that SHR7280 300 mg BID and above suppressed estrogen concentration within the estradiol (E) treatment window for endometriosis (20-50 pg/ml), inhibited the emergence of the peak of luteinizing hormone (LH) and the concentration of follicle stimulating hormone (FSH), and maintained the concentration of progesterone (P) in an anovulatory state (2 nmol/L). This study supports the continued clinical development of SHR7280 as a GnRH antagonist for sex hormone-dependent disorders in women. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04554043, Identifier NCT04554043."

Clinical • Journal • PK/PD data • Endometriosis • Gynecology • Women's Health