[Translation] A multicenter, randomized, open-label phase III clinical study to evaluate the efficacy, safety, and pharmacokinetics of leuprorelin emulsion injection in the treatment of premenopausal breast cancer

以给药后第4周至48周血清E2浓度维持在绝经后水平（≤ 30 pg/mL）的抑制率为有效性评价的替代性指标，评估亮丙瑞林注射乳剂给药后治疗绝经前乳腺癌的疗效。

[Translation]

The efficacy of leuprorelin emulsion injection in the treatment of premenopausal breast cancer was evaluated using the inhibition rate of serum E2 concentration maintained at postmenopausal levels (≤ 30 pg/mL) from the 4th to 48th week after administration as a surrogate indicator for efficacy evaluation.

Start Date21 Aug 2024

Sponsor / Collaborator

FAREVA PAU

[+2]

NCT06449027

/ Not yet recruitingPhase 3

A Phase III, Multicenter, Randomized, Open-Label Study to Assess the Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

Start Date01 Jun 2024

Sponsor / Collaborator

Changchun Genescience Pharmaceuticals Co., Ltd.

NCT06397703

/ RecruitingPhase 2IIT

A Phase II Prospective 2-Arm Cohort Interventional Trial Utilizing Ultra-Hypofractionated SBRT With or Without Short Course Androgen Deprivation Therapy For Unfavorable Intermediate Risk Prostate Cancer

For this study, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone. The patient population will include those with National Comprehensive Cancer Network (NCCN)-defined unfavorable intermediate risk disease. All patients will be followed every 6 months for up to 5 years from the first patient treated and will undergo a routine 24-30 months post-SBRT prostate biopsy to assess for local tumor control.

Start Date16 Apr 2024

Sponsor / Collaborator

NYU Langone Health

100 Clinical Results associated with Leuprolide Mesylate

100 Translational Medicine associated with Leuprolide Mesylate

100 Patents (Medical) associated with Leuprolide Mesylate

Literatures (Medical) associated with Leuprolide Mesylate

01 Oct 2024·JOURNAL OF ONCOLOGY PHARMACY PRACTICE

Review of drug-drug interactions in patients with prostate cancer

Review

Author: Ruplin, Andrew ; Segal, Eve ; McFarlane, Tom

Objective:

The objective of this review is to provide an overview of common drug-drug interactions (DDIs) associated with prostate cancer treatments and outline recommendations for managing polypharmacy.

Data sources:

A literature search of PubMed, Embase, and CINAHL was carried out to identify pharmacokinetic and pharmacodynamic changes caused by DDIs that are relevant for prostate cancer patients, DDIs between prostate cancer therapies and co-administered medications (both prescription and over-the-counter), and measures to prevent DDIs. Medication package inserts were used to identify the impact of DDI on the prostate cancer therapy and suggested interventions.

Data summary:

No DDIs are expected for the LHRH agonists leuprolide acetate, histrelin, goserelin, or leuprolide mesylate. However, DDIs have been reported for GnRH antagonists, anti-androgens, PARP inhibitors, and taxanes. Although there are no confirmed DDIs for sipuleucel-T to date, it is not generally recommended to use sipuleucel-T concurrently with immunosuppressive medications. Interventions to prevent DDIs include the use of software that can detect clinically significant DDIs, up-to-date medication reconciliation, the inclusion of dedicated clinical pharmacists in cancer treatment teams, and patient/caregiver education.

Conclusions:

Prostate cancer patients have a high risk of potential DDIs due to numerous new anti-cancer therapies, the increased use of treatment combinations, and the likelihood of comorbid conditions also requiring drug therapy. Drug-drug interaction screening software, up-to-date medication reconciliation, inclusion of oncology pharmacists on healthcare teams, and patient/caregiver education will aid the development of treatment plans that focus on achieving an optimal risk-benefit profile whilst reducing the risk of DDIs.

01 Sep 2022·Biomaterials

Suspension culture of human induced pluripotent stem cell-derived intestinal organoids using natural polysaccharides

Article

Author: Iwao, Takahiro ; Kanaki, Tatsuro ; Hayashi, Hisato ; Matsunaga, Tamihide ; Ogawa, Isamu ; Anno, Shiho ; Onozato, Daichi

Currently, there are many challenges in the culture of human induced pluripotent stem (iPS) cell-derived intestinal organoids (HIOs) for use in drug discovery, disease research, and regenerative medicine. For example, the main culture method, embedding culture, makes industrial large-scale culture difficult, and Matrigel, which is used for almost all HIO cultures, is not respected for its application in regenerative medicine. To overcome these challenges, we herein propose a new culture method using low concentrations of natural polysaccharides in a suspension culture. In the present study, five natural polysaccharides free from heterologous animal-derived components were used, and HIOs were successfully cultured in suspension with FP001 and FP003, which are microbial exopolysaccharide analogs of gellan gum. The fabricated HIOs were similar to living intestinal tracts with respect to their gene expression, microstructure, and protein expression. The observed activities of the drug metabolizing enzymes and drug transporters in the generated HIOs suggested that they have pharmacokinetic functions. We believe that suspension culture of HIOs using FP001 or FP003 can be widely applied to not only drug discovery research but also disease research and regenerative medicine.

01 Jan 2020·World journal of urology

A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients

Article

Author: Jievaltas, Mindaugas ; Mao, John ; DeGuenther, Mark ; Li, Yuhua ; Simpson, Kelle ; Patockova, Jitka ; Chien, Ben ; Huang, Shih-Tsung ; Hu, Chu-Hsuan ; Lee, Yisheng ; Mincik, Ivan ; Student, Vladimir ; Shore, Neal

OBJECTIVES:

To determine the safety, efficacy and pharmacokinetic (PK) profile of a pre-mixed depot formulation of leuprolide mesylate subcutaneous injectable suspension (LMIS) 50 mg for up to 1 year of treatment for subjects with advanced prostate cancer.

PATIENTS AND METHODS:

In this open-label, multicenter study, prostate cancer patients with indication for androgen ablation therapy received two subcutaneous injection of LMIS 50 mg 6 months apart and were followed for an additional 6 months. Two efficacy primary end points were the percentage of subjects with a serum testosterone level ≤ 50 ng/dL by Day 28 as well as the percentage of subjects with similar testosterone suppression from Day 28 to Day 336.

RESULTS:

Of the 137 enrolled subjects, 15 (10.9%) subjects did not complete the study, including 5 subjects who terminated early due to an adverse event. By Day 28, 98.5% (95% confidence interval 94.8-99.8) of the subjects achieved a castrate testosterone level. At the end of the study, 97% and 95.9% of the subjects had serum testosterone level ≤ 50 ng/dL and ≤ 20 ng/dL, respectively. LMIS 50 mg significantly reduced serum prostate-specific antigen levels after its first injection and this PSA declination effect remained until the end of the study. No statistically significant change was observed in worsening bone pain or urinary symptom assessments during the study. Hot flush (48.9%) and hypertension (14.6%) were the two most common adverse events reported.

CONCLUSIONS:

LMIS 50 mg, administered at 6-month intervals, effectively suppressed serum testosterone level, and demonstrated a consistent safety profile.

News (Medical) associated with Leuprolide Mesylate

17 Feb 2025

·www.prnewswire.com

Foresee Pharmaceuticals Receives the Third Positive Recommendation from the DSMB to Continue the Casppian Study

The independent Data and Safety Monitoring Board (DSMB) recommended the continuation of patient enrollment as planned. There has been no safety concern with the use of leuprolide (FP-001) injectable Emulsion in pediatric CPP patients. TAIPEI, Feb. 17, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces the third positive safety review by the independent Data and Safety Monitoring Board for its Casppian Phase 3 registration study. The DSMB recommended that Foresee Pharmaceuticals continue the trial as planned without any modification. The Casppian Phase 3 study is an open-label, multicenter, multinational clinical trial to evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg- controlled release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP). Foresee's leuprolide injectable emulsion, 42 mg (marketed under the brand name CAMCEVI®), is currently approved for the treatment of adult patients with advanced prostate cancer and has demonstrated positive efficacy and safety results with statistically significant treatment effects in adult male patients with advanced prostate cancer. "The third favorable review from the DSMB, received after reaching nearly 75% enrollment in the Casppian trial, reinforces the promising safety data for FP-001 42 mg administered every six months in children with CPP. Early efficacy signals further support our confidence that this therapy could represent a groundbreaking advancement for pediatric patients with CPP. We are committed to swiftly completing enrollment while upholding the utmost safety and ethical rigor standards throughout this pivotal study," said Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development of Foresee. "This DSMB recommendation again highlights the effectiveness of Foresee's innovative Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology across several disease indications, including in children with CPP," said Dr. Yuhua Li, Chief Technology Officer of Foresee. "The outcome from the third DSMB for the Casppian study represents a major advancement in our mission to enhance the standard of care and improve the quality of life for children with CPP.," said Dr. Ben Chien, CEO and Chairman of Foresee. "This positive recommendation moves us nearer to our objective of providing safe and effective treatments for children in need, as well as to the anticipated top-line results from this trial, expected in 2025." About CPP GnRH-dependent CPP is a condition that causes early sexual development in girls and boys, as their "hypothalamus - pituitary gland - gonadal axis" is activated too early, causing children to enter puberty prematurely, between 2 years and 9 years of age. CPP patients are at risk of having significantly short stature as adults in addition to social, psychological, and emotional issues, including lower self-esteem, stress, anxiety, and depression, which may negatively impact their quality of life. According to the NORD (National Organization for Rare Disorders) website, CPP occurs in 1 out of 5,000 to 10,000 children. It is estimated that approximately 80% - 90% of CPP cases are idiopathic, especially in females, with a female-to-male ratio of around 20. Gonadotropin-releasing hormone (GnRH) agonists, including leuprolide, are the most widely used treatment for CPP. About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, or the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted and accepted for review with a PDUFA date of August 29, 2025, while the EU regulatory submission for the 3-month version of CAMCEVI is still under preparation. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study is ongoing. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. Triptorelin (FP-014), aiming for the treatment of advanced prostate cancer, is ready to enter Phase 3 clinical studies, with respective trials planned for the 3-month and 6-month ready-to-use LAI formulations. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted at severe asthma, COPD, and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is ongoing, and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the first quarter of 2025. Building on the compelling biology of ALDH2 and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultPhase 1Drug ApprovalPhase 2

10 Feb 2025

·www.prnewswire.com

Foresee Pharmaceuticals Announces Acceptance of An Abstract for Presentation at ASCO Genitourinary Cancers Symposium 2025

TAIPEI, Feb. 10, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576) ("Foresee") announced today the acceptance of an abstract for presentation at the prestigious American Society of Clinical Oncology, Genitourinary (ASCO-GU) Cancers Symposium conference, which will be held at the Moscone Convention Center West in San Francisco, CA, from February 13 to 15, 2025. The abstract is titled: "Global, Phase 3, Open-Label, Single-Arm Studies to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg (Triptorelin Mesylate Injection, 11.25 mg) and FP-014, 22.5 mg (Triptorelin Mesylate Injection, 22.5 mg) in Patients with Advanced Prostate Cancer (KATANA studies).", and highlights our commitment to improve advanced prostate cancer treatment. Building on the success of CAMCEVI® and our SIF-LAI technology, the KATANA studies will help evaluate the efficacy and safety of FP-014 11.25 mg every 3 months and 22.5 mg, every 6-months injections which have the potential to provide significant benefits for patients with advanced prostate cancer, with its unique and differentiated profile offer substantial benefits for an opportunity to become the only available ready-to-use triptorelin long-acting injectable ("LAI"). Poster Board Number: M3 Abstract Number: TPS284 Session Title: Trials in Progress Poster Session A: Prostate Cancer Date and Time: Thursday, February 13, 2025, from 11:25 AM-12:45 PM PT Location: Level 1, West Hall () "This prestigious event brings together leading urology, oncology, and cancer research experts to discuss the latest advancements and findings related to prostate cancer," said Dr. Yisheng Lee, Chief Medical Officer at Foresee. "The accepted abstract presents our differentiated FP-014 Phase 3 clinical program and highlights our broad efforts in developing new treatment modalities and differentiated treatments for prostate cancer patients, contributing to the ongoing dialogue surrounding prostate cancer care and research," added Dr. Lee. "This acceptance demonstrates the success of Foresee's pioneering SIF-LAI technology across several product types and indications, further highlighting the broad potential of this technology in developing best-in-class ready-to-use LAI's," said Dr. Yuhua Li, Chief Technology Officer at Foresee. "It represents an important opportunity for our work to be recognized globally," said Dr. Ben Chien, Foresee's Chairman and CEO. "We are excited to initiate our studies later this year, as we see a remarkable opportunity to capture a significant share of the triptorelin market around the world in view of FP-014's best-in-class profile." The abstract will become available on the Foresee website after the conference. About FP-014 (triptorelin) FP-014 (triptorelin) is a ready-to-use, subcutaneous, long-acting injectable dosage form administered every three months or six months, thereby reducing the frequency of administration to patients to ensure better compliance. Triptorelin is a common palliative treatment for men with advanced or metastatic prostate cancer. It is also prescribed for the treatment of premenopausal breast cancer, precocious puberty, endometriosis, uterine fibroids, etc. About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, or the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted and accepted for review with a PDUFA date of August 29, 2025, while the EU regulatory submission for the 3-month version of CAMCEVI is still under preparation. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study is ongoing. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. Triptorelin (FP-014), aiming for the treatment of advanced prostate cancer, is ready to enter Phase 3 clinical studies, with respective trials planned for the 3-month and 6-month ready-to-use LAI formulations. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted at severe asthma, COPD, and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is ongoing and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the first quarter of 2025. Building on the compelling biology of ALDH2 and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultPhase 1Phase 2Drug Approval

13 Jan 2025

·www.prnewswire.com

Foresee Pharmaceuticals Announces the PDUFA Goal Date for the 3-month Version of CAMCEVI is August 29, 2025

TAIPEI, Jan. 13, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") announces that the U.S. Food and Drug Administration (FDA) issued a Day-74 letter. The Day-74 letter states that the PDUFA goal date for a decision on marketing approval for the 3-month version of CAMCEVI (leuprolide mesylate 21 mg, 3-month long-acting injectable (LAI) formulation) for the treatment of adult patients with advanced prostate cancer is August 29, 2025. "This marks another important regulatory milestone for the CAMCEVI franchise," said Dr. Ben Chien, Founder and Chairman of Foresee. "With the PDUFA goal date now set, we look forward to working with the FDA through the regulatory process to bring this treatment option closer to potential regulatory approval, followed by the successful commercial launch of CAMCEVI 21 mg in near future, providing patients and the medical community with a 3-month CAMCEVI LAI in addition to CAMCEVI 42 mg 6-month LAI, currently on the market. Foresee will have a complete, differentiated ready-to-use franchise." The NDA submission for the 3-month version of CAMCEVI is supported by a previously communicated successful Phase 3 clinical study with a total of 144 advanced prostate carcinoma patients enrolled, in which treatment with leuprolide mesylate injection every 3 months was demonstrated to be effective, safe and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint. About Foresee Pharmaceuticals Co., Ltd. Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg or the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted, while the EU regulatory submission for the 3-month version of CAMCEVI is still under preparation. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study, is ongoing. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, for which a Phase 1 study in healthy volunteers has been successfully completed, with development targeted in severe asthma, COPD and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is ongoing, and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the first quarter of 2025. Building on the compelling biology of ALDH2, and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3NDAPhase 2Drug Approval

100 Deals associated with Leuprolide Mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L02AE02	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Prostate Carcinoma	Israel	Foresee Pharmaceuticals Co., Ltd.	11 Jul 2024
Hormone-dependent prostate cancer	European Union	Accord Healthcare SLU	24 May 2022
Hormone-dependent prostate cancer	Iceland	Accord Healthcare SLU	24 May 2022
Hormone-dependent prostate cancer	Liechtenstein	Accord Healthcare SLU	24 May 2022
Hormone-dependent prostate cancer	Norway	Accord Healthcare SLU	24 May 2022
Prostatic Cancer	United States	Accord BioPharma, Inc.	25 May 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Premenopausal breast cancer	Phase 3	China	Changchun Genescience Pharmaceuticals Co., Ltd.	01 Jun 2024
Puberty, Precocious	Phase 3	United States	Changchun Genescience Pharmaceuticals Co., Ltd.	02 Jun 2023
Puberty, Precocious	Phase 3	United States	Foresee Pharmaceuticals Co., Ltd.	02 Jun 2023
Puberty, Precocious	Phase 3	China	Changchun Genescience Pharmaceuticals Co., Ltd.	02 Jun 2023
Puberty, Precocious	Phase 3	China	Foresee Pharmaceuticals Co., Ltd.	02 Jun 2023
Puberty, Precocious	Phase 3	Puerto Rico	Changchun Genescience Pharmaceuticals Co., Ltd.	02 Jun 2023
Puberty, Precocious	Phase 3	Puerto Rico	Foresee Pharmaceuticals Co., Ltd.	02 Jun 2023
Puberty, Precocious	Phase 3	Taiwan Province	Changchun Genescience Pharmaceuticals Co., Ltd.	02 Jun 2023
Puberty, Precocious	Phase 3	Taiwan Province	Foresee Pharmaceuticals Co., Ltd.	02 Jun 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04194554 (ASCLEPIuS, ASCO_GU2025) Manual	Phase 1/2	Prostatic Cancer	54	Abiraterone acetate + Leuprolide + Niraparib	wvqcgmoxqi(yxueurdxce) = dnqmuekrtj jhfutanxxl (oqcmiulbzh ) View more	Positive	13 Feb 2025
NCT04051320 (CTgov)	Phase 2	Depression, Postpartum \| Irritable Mood	23	Estradiol 2 Mg tablet+Micronized progesterone+Leuprolide Acetate 3.75 MG/ML (Hormone Sensitive Women (HS+))	fwvpkpyznr(wliaghbkby) = wfipydbkmk csgkypbune (lwkddewpya, 18.92) View more	-	25 Aug 2023
NCT04051320 (CTgov)	Phase 2	Depression, Postpartum \| Irritable Mood	23	Estradiol 2 Mg tablet+Micronized progesterone+Leuprolide Acetate 3.75 MG/ML (Hormone Insensitive Women (HS-))	fwvpkpyznr(wliaghbkby) = oabepylrhu csgkypbune (lwkddewpya, 110.98) View more	-	25 Aug 2023
NCT02807363 (CTgov)	Phase 2	Endometriosis	35	Leuprolide (Leuprolide Oral Tablet, 4 mg QD (Treatment A))	vnlijiofig = ypwnwhctvw uwjdkrypng (iithjilbue, umkrjvhdel - urfngfgdgu) View more	-	11 Feb 2022
NCT02807363 (CTgov)	Phase 2	Endometriosis	35	Leuprolide (Leuprolide Oral Tablet, 4 mg BID (Treatment B))	vnlijiofig = hljenqtift uwjdkrypng (iithjilbue, eoynjhnkyq - ngtcsffckn) View more	-	11 Feb 2022
NCT02508636 (CTgov)	Phase 2	Prostatic Cancer \| Sarcoidosis	11	Enzalutamide+Leuprolide	scvdeyexlo = znsnalsdsm whqfexpccv (rljgajtkdn, zumcgjgmum - sjgajsveld) View more	-	12 Oct 2021
NCT03261999 (CTgov)	Phase 3	Prostatic Cancer	144	Leuprolide Mesylate	tmcgcvyvqt = qenhopeakf rebcmvygfd (yekusutcat, mxhiufsgoz - ftejrjjanz) View more	-	04 May 2020
NCT02508636 (ASCO_GU2020)	Phase 2	Prostatic Cancer	16	Leuprolide and Enzalutamide	ubgotfxocj(poksvlggak) = juzigpxhxo rqwjfgzayo (qunphvbkbu, 3.47 - 4.87)	-	19 Feb 2020
NCT00123110 (CTgov)	Phase 2	Insulin Resistance	35	Metformin (Metformin)	rrwsurlgur(ehlezntdyp) = trrgamcqma lhgrsrzlxe (vpulhihykj, 22.8) View more	-	23 May 2019
NCT00123110 (CTgov)	Phase 2	Insulin Resistance	35	Leuprolide (Leuprolide)	rrwsurlgur(ehlezntdyp) = tauygmzrzd lhgrsrzlxe (vpulhihykj, 31.8) View more	-	23 May 2019
NCT02712320 (CTgov)	Phase 3	Advanced Prostate Carcinoma	30	LMIS 50 mg	dhpiwexcbt = rzujoxocvk nhwjumavat (cxczizlebf, fitbfkuuby - umapznydga) View more	-	12 Sep 2018
NCT02234115 (CTgov)	Phase 3	Advanced Prostate Carcinoma	137	Leuprolide Mesylate	qvwrqkzwpn(agnfhgcrrr) = yrlybbsrlb wsdbidbwsm (tsapxuhemx, mtecvgvfph - sturldxyfs) View more	-	13 Apr 2018

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