A Global, Phase 3, Open-Label, Single Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg (Triptorelin Mesylate Injection, 11.25 mg) in Patients With Advanced Prostate Cancer (KATANA E3M)

This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 26 weeks.
Eligibility will be assessed during a screening period of up to 28 days. Up to 2 doses of a long-acting FP-014, 11.25 mg formulation will be given to the patients by separate SC injections 12 weeks apart in an unblinded manner. The first dose of FP-014, 11.25 mg, will be administered on Day 0 (Visit 2/Week 1). When patients have tolerated the first dose of FP-014, 11.25 mg and have achieved castrate levels of serum testosterone, a second dose will be administered on Day 84 (Visit 13/Week 12) to achieve castrate levels of serum testosterone concentrations (< 50 ng/dL). Patients will be followed for efficacy, safety, tolerability, and ancillary clinical and laboratory markers for an additional 12-week observation period (Day 168/Week 24/ Visit 22).
Blood samples will be collected at Baseline (Day 0/Week 1) at least 30 minutes before the first FP-014, 11.25 mg administration, immediately thereafter and at specified time points through Day 168 (Week 24) to determine pharmacokinetic (PK) (triptorelin) and pharmacodynamic (PD) (testosterone, PSA, and LH) profiles.

Start Date01 Jul 2025

Sponsor / Collaborator

Foresee Pharmaceuticals Co., Ltd.

[+1]

NCT06795191

/ WithdrawnPhase 3

A Global, Phase 3, Open-Label, Single Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 22.5 mg (Triptorelin Mesylate Injection, 22.5 mg) in Patients With Advanced Prostate Cancer (KATANA E6M)

This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 48 weeks.
Eligibility will be assessed during a screening period of up to 28 days. Up to 2 doses of a long-acting FP-014, 22.5 mg formulation will be given to the patients by separate SC injections 24 weeks apart in an unblinded manner. The first dose of FP-014, 22.5 mg will be administered on Day 0 (Visit 2/Week 1). When patients have tolerated the first dose of FP-014, 22.5 mg and have achieved castrate levels of serum testosterone, a second dose will be administered on Day 168 (Visit 14/Week 24) to achieve castrate levels of serum testosterone concentrations (< 50 ng/dL). Patients will be followed for efficacy, safety, tolerability, and ancillary clinical and laboratory markers for an additional 24-week observation period (Day 336/Week 48/ Visit 24) Blood samples will be collected at Baseline (Day 0/Week 1) at least 30 minutes before the first FP-014, 22.5 mg administration, immediately thereafter and at specified time points through Day 336 (Week 48) to determine PK (triptorelin) and pharmacodynamics (PD) (testosterone, PSA, and LH) profiles.

Start Date01 Jun 2025

Sponsor / Collaborator

Foresee Pharmaceuticals Co., Ltd.

[+1]

NCT06763926

/ Not yet recruitingPhase 4IIT

Intranasal Nafarelin Compared to Subcutaneous Triptorelin for Triggering Final Oocyte Maturation in Ovarian Stimulation: a Non-inferiority Randomised Controlled Clinical Trial

This is a non-inferiority randomised, controlled clinical trial comparing subcutaneous triptorelin to intranasal nafarelin for the final maturation of oocytes in oocyte donors undergoing ovarian stimulation.

Start Date15 Mar 2025

Sponsor / Collaborator-

100 Clinical Results associated with Triptorelin Pamoate

100 Translational Medicine associated with Triptorelin Pamoate

100 Patents (Medical) associated with Triptorelin Pamoate

2,082

Literatures (Medical) associated with Triptorelin Pamoate

04 Mar 2025·Brain Communications

Enduring differential patterns of neuronal loss and myelination along 6-month pulsatile gonadotropin-releasing hormone therapy in individuals with Down syndrome

Article

Author: di Domenicantonio, Giulia ; Sebbah, Raphael ; Draganski, Bogdan ; Vionnet, Nathalie ; Lutti, Antoine ; Adamo, Michela ; Kherif, Ferath ; Raynaud, Quentin ; Pitteloud, Nelly ; Latypova, Adeliya ; Jacobs, An ; Gayer, Mihaly

Abstract:

Despite major progress in understanding the impact of the triplicated chromosome 21 on the brain and behaviour in Down syndrome, our knowledge of the underlying neurobiology in humans is still limited. We sought to address some of the pertinent questions about the drivers of brain structure differences and their associations with cognitive function in Down syndrome. To this aim, in a pilot magnetic resonance imaging (MRI) study, we monitored brain anatomy in individuals with Down syndrome receiving pulsatile gonadotropin-releasing hormone (GnRH) therapy over 6 months in comparison with typically developed age- and sex-matched healthy controls. We analysed cross-sectional (Down syndrome/healthy controls n = 11/27; Down syndrome—2 females/9 males, age 26.7 ± 5.0 years old; healthy controls—8 females/19 males, age 24.1 ± 2.5 years old) and longitudinal (Down syndrome/healthy controls n = 8/13; Down syndrome—1 female/7 males, age 26.4 ± 5.3 years old; healthy controls—4 females/9 males, 24.7 ± 2.2 years old) relaxometry and diffusion-weighted MRI data alongside standard cognitive assessment. The statistical tests looked for cross-sectional baseline differences and for differential changes over time between Down syndrome and healthy controls. The post hoc analysis confined to the Down syndrome group, tested for potential time-dependent interactions between individuals’ overall cognitive performance and associated brain anatomy changes. The brain MRI statistical analyses covered both grey and white matter regions across the whole brain allowing for investigation of regional volume, macromolecular/myelin and iron content, additionally to diffusion tensor and neurite orientation and dispersion density characterization across major white matter tracts. The cross-sectional analysis showed reduced frontal, temporal and cerebellar volumes in Down syndrome with only the cerebellar differences remaining significant after adjustment for the presence of microcephaly (Pfamily-wise-corrected < 0.05). The volume reductions were paralleled by decreased cortical and subcortical macromolecular/myelin content confined to the cortical motor system, thalamus and basal ganglia (Pfamily-wise-corrected < 0.05). All major white matter tracts showed a ubiquitous mean diffusivity and intracellular volume fraction reduction contrasted with no differences in magnetization transfer saturation metrics (Pfamily-wise-corrected < 0.05). Compared with healthy controls over the same period, Down syndrome individuals under GnRH therapy showed cognitive improvement (Montreal Cognitive Assessment from 11.4 ± 5.5 to 15.1 ± 5.6; P < 0.01) on the background of stability of the observed differential neuroanatomical patterns. Despite the lack of adequate Down syndrome control group, we interpret the obtained cross-sectional and longitudinal findings in young adults as evidence for predominant neurodevelopmental neuronal loss due to dysfunctional neurogenesis without signs for short-term myelin loss.

25 Feb 2025·JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM

Central precocious puberty in a toddler with hypothalamic hamartoma

Article

Author: Büyükyılmaz, Gönül ; Turhan, Banu ; Boyraz, Mehmet

Abstract:

Objectives:

Hypothalamic hamartoma (HH) is a rare condition that causes epilepsy and central precocious puberty (CPP) at an early age. In this report, we describe a child with CPP secondary to HH and discuss the current literature.

Case presentation:

A 26-month-old girl was brought to our hospital for evaluation of breast enlargement. Her parents were first-degree relatives. Her breast development was categorized as Tanner stage 3, and her bone age was 7 years/4 months. Laboratory investigations were consistent with CPP. Brain magnetic resonance imaging (MRI) revealed a smooth, spherical lesion in the hypothalamus, located in the tuber cinereum and measuring 11 × 9 × 10 mm. The lesion was identified as a HH. The patient was started on gonadotropin-releasing hormone analogue therapy, specifically 200 μg/kg/month of leuprolide acetate (3.75 mg depot) administered intramuscularly every 28 days. During the 2-year follow-up, her breast development remained at Tanner stage 3, and she did not develop axillary or pubic hair. Her bone age was 7 years/6 months (chronological age; 4 years/2 months). 2-year follow-up MRI showed no change in the size or contours of the HH compared with the initial diagnosis. No side effects from the medical treatment were observed during the follow-up period.

Conclusions:

In patients under the age of 4 years showing signs of CPP, HH should be considered as diagnosis. All patients receiving medical treatment should be closely monitored.

15 Jan 2025·Clinical and experimental pediatrics

Efficacy of leuprolide acetate versus triptorelin pamoate administered every 3 months for treatment of central precocious puberty

Article

Author: Thaneetrakool, Thanaporn ; Numsriskulrat, Nattakarn ; Wacharasindhu, Suttipong ; Srilanchakon, Khomsak ; Aroonparkmongkol, Suphab ; Supornsilchai, Vichit

Background: Central precocious puberty (CPP) is typically treated with gonadotropin-releasing hormone (GnRH) agonists. Although numerous GnRH agonist variants are available, limited research has compared the efficacy of leuprolide acetate and triptorelin pamoate administered at 3-month intervals.Purpose: This study aimed to assess the efficacy of CPP treatment with triptorelin pamoate and leuprolide acetate administered at 3-month intervals.Methods: This retrospective cohort study included 116 girls with CPP: 71 treated with leuprolide acetate every 3 months and 45 treated with triptorelin pamoate every 3 months. Anthropometric measurements were compared before and after therapy. At 6 months after the therapy, luteinizing hormone (LH) suppression was evaluated.Results: When administered every 3 months, leuprolide acetate and triptorelin pamoate significantly suppressed LH. The predicted adult height (PAH) and degree of bone age advancement at the end of treatment were comparable.Conclusion: Treatment with leuprolide acetate and triptorelin pamoate every 3 months did not have significantly different effects on LH suppression or PAH.

News (Medical) associated with Triptorelin Pamoate

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

04 Dec 2024

·www.prnewswire.com

Foresee Pharmaceuticals Announces Completion of US$42.1 Million Financing

TAIPEI, Dec. 4, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") announces that it has successfully completed an underwritten public offering of 18,000,000 shares of its common stock to the public at a price of NT$76 per share. The aggregate gross proceeds to Foresee from the offering were NT$1,368 million (or US$42.1 million at FX=32.5). The proceeds of the public offering will be used for general corporate purposes, including FP-014 (triptorelin), a ready-to-use long-acting injectable, administered either every three months or six months, in two Phase 3 clinical trials for advanced prostate cancer, respectively; FP-020 (linvemastat), an MMP-12 inhibitor, in two Phase 2 studies for both asthma and inflammatory bowel disease (IBD), and FP-045 (mirivadelgat), an ALDH2 activator, in a Phase 2 clinical trial for pulmonary hypertension associated with interstitial lung disease (PH-ILD). "We are pleased to announce the successful completion of the public offering. I would like to express my gratitude once again for shareholders' full support and trust in us." said Dr. Ben Chien, Founder and Chairman of Foresee. "This funding will enable us to accelerate our R&D progress and create more value for our shareholders." 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. Another indication of CAMCEVI 6-month LAI formulation, premenopausal breast cancer, the Phase 3 clinical trial in China is ongoing as well. 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

Phase 2Phase 3Clinical ResultPhase 1Drug Approval

09 Sep 2024

·www.debiopharm.com

First Patients Dosed in Debiopharm’s Phase III Trial (LIBELULA) Investigating Debio 4326, A 12-Month Triptorelin Formulation for Children with Central Precocious Puberty

Debiopharm’s expertise in extended-release formulations could lighten the burden of treatment for children with Central Precocious Puberty (CPP) and their families by reducing injection frequency to once a year Lausanne, Switzerland – September 9th, 2024 – Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to develop innovative therapies and to improve patient quality of life, today announced the dosing of the first sentinel patients in its open-label, single-arm, multi-center Phase III study, NCT06129539 ‘A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty (LIBELULA)’. Triptorelin is an established treatment for CPP as a 1-, 3- and 6-month formulation. This new phase III study evaluating the novel 12-month triptorelin formulation is being carried out in North and South America. In pursuit of developing safe, effective, and convenient treatment options for patients, Debiopharm, is applying its expertise in extended-release formulations to achieve the first yearly injectable Gonadotropin-Releasing Hormone agonist (GnRHa). Reducing treatment burden while preserving triptorelin’s well-known efficacy and safety are key elements that Debiopharm is eager to assess through this study. “It is always disheartening to see such young children burdened by the effects of central precocious puberty and the lifelong complications it may cause. We are thankful that treatments like triptorelin are already on the market, and that companies like Debiopharm continue to invest in lightening the patient care burden with formulations that reduce injection frequency.” expressed Prof. Fernando Cassorla, Principal Investigator, Pediatrics Department at the Hospital San Borja Arriarán in Santiago, Chile. “As patients are at the center of all we do, we recognize that convenience matters. Reducing injection frequency to once a year can lower the burden for CPP patients and their caretakers by reducing children’s stress and improving overall compliance. We are enthusiastic about the first patients enrolled in this phase III trial that can bring both medical and practical advancements.” expressed Bertrand Ducrey, CEO of Debiopharm. About Central Precocious Puberty Central precocious puberty (CPP) occurs at an unusually early age, before 8 years of age in girls and before 9 years of age in boys [1-2]. It is characterized by a premature development of secondary sexual characteristics (e.g. breasts for girls and enlarged testicles for boys), accelerated growth, and bone maturation leading to reduced adult height. CPP is triggered by the early release of the gonadotropin-releasing hormone in the brain and premature activation of the hypothalamic-pituitary-gonadal axis. This early activation can be due to specific genetic alterations, central nervous system lesions, and social stressors but frequently has no identified etiology [3]. The approximative prevalence of CPP is 1 in 5,000-10,000 among Caucasians, more frequent in girls than in boys globally [4]. Precocious puberty may be associated with psychosocial difficulties and carries potential negative implications for long-term health including increased risk of metabolic complications, such as type 2 diabetes, weight gain, obesity, cardiovascular disease, as well as depression, and even premature death [5-10]. Early puberty has also been associated with an increased risk of breast cancer in women. In men, it may increase the risk of prostate cancer [11-13]. Since the early 1980s, Gonadotropin-Releasing Hormone agonists (GnRHa) such as triptorelin have been the standard of care for the treatment of CPP [14-16]. Treatment aims to preserve adult height and prevent social and psychological difficulties and the various potential consequences on long-term health. Currently, there are several different extended-release GnRHa formulations ranging from monthly injections to subcutaneous implants for annual use [17]. While the latter may have a longer duration of action, it requires yearly surgical positioning. About Debio 4326 Debio 4326 is a unique injectable, biodegradable 12-month extended-release formulation of triptorelin designed to further reduce the frequency of injections and burden of administrations, particularly considering its intended use in a pediatric population. Based on favorable efficacy and safety data with the different triptorelin 1-, 3- and 6-month formulations, Debio 4326 aims to preserve efficacy while providing increased comfort, ensure long-term compliance, and reduce stress for children and their parents. Debiopharm’s commitment to patients Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit www.debiopharm.com We are on X. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews Sources [1] Latronico AC, et al. Lancet Diabetes Endocrinol. 2016;4(3):265–274. [PubMed: 26852255] [2] Sanctis V, et al. Acta biomedica: Atenei Parmensis. 2019 90 (3): 345-359. [3] Maione L, et al. Clin Endocrinol (Oxf). 2021 Oct;95(4):542-555. doi: 10.1111/cen.14475. Epub 2021 Apr 20. PMID: 33797780; PMCID: PMC8586890 [4] National Organization for Rare Disorders (NORD) 2022 [5] Day FR, et al. 2015. Sci Rep, 5: 11208. [6] Elks CE, et al. 2013. Diabetes Care, 36 (11): 3526-34. [7] Prentice P, and Viner RM. 2013. Int J Obes (Lond), 37 (8): 1036-43 [8] Ong KK, et al. 2012. J Clin Endocrinol Metab, 97 (8): 2844-52. [9] Hamlat EJ, et al. 2014. J Abnorm Child Psychol, 42 (4): 527-38. [10] Charalampopoulos D, et al. 2014. Am J Epidemiol, 180 (1): 29-40. [11] Day FR, et al. 2017. Nat Genet, 49 (6): 834-41. [12] Bonilla C, et al. 2016. BMC Med, 14: 66. [13] Bräuner EV, et al. 2020. JAMA Netw Open, 3 (10): e2015665 [14] Carel JC, et al. 2009. Pediatrics, 123 (4): e752-62. [15] Bertelloni S, et al. 2015. Horm Res Paediatr, 84 (6): 396-400. [16] Bangalore Krishna K, et al. 2019. Horm Res Paediatr, 91 (6): 357-72. [17] Aguirre RS, Eugster EA. Best Pract Res Clin Endocrinol Metab. 2018;32(4):343–354.

Phase 3Phase 2

100 Deals associated with Triptorelin Pamoate

External Link

KEGG	Wiki	ATC	Drug Bank
D06248	Triptorelin Pamoate	L02AE04	DB06825

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Puberty, Precocious	United States	Azurity Pharmaceuticals, Inc.	29 Jun 2017
Hormone-dependent prostate cancer	Australia	Ipsen Pty Ltd.	28 Aug 2006
Prostatic Cancer	South Korea	Ferring Pharmaceuticals Korea Co., Ltd.	04 Nov 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Familial Testotoxicosis	NDA/BLA	China	Ipsen SA	22 Jan 2007
Cysts	Phase 3	Indonesia	-	02 Jan 2024
Endometriosis	Phase 3	China	Ipsen SA	28 Jul 2017
Metastatic Prostate Carcinoma	Phase 3	Bulgaria	Ipsen SA	01 Jan 2013
Metastatic Prostate Carcinoma	Phase 3	France	Ipsen SA	01 Jan 2013
Metastatic Prostate Carcinoma	Phase 3	Poland	Ipsen SA	01 Jan 2013
Advanced Prostate Carcinoma	Phase 3	Belgium	Ipsen SA	01 Nov 2009
Advanced Prostate Carcinoma	Phase 3	Denmark	Ipsen SA	01 Nov 2009
Advanced Prostate Carcinoma	Phase 3	France	Ipsen SA	01 Nov 2009
Advanced Prostate Carcinoma	Phase 3	Italy	Ipsen SA	01 Nov 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05029622 (Pubmed \| Adv Ther)	Phase 3	Puberty, Precocious	66	Triptorelin pamoate 22.5 mg	emrvshefol(njebmaxkbw) = Thirteen patients (19.7%) had 22 drug-related treatment emergent adverse events (TEAEs); no grade ≥ 3 TEAEs were reported fovlogvknr (ihcbbvzqrr ) View more	Positive	01 Dec 2024
ESMO2024 Manual	Not Applicable	AR Positive Salivary Gland Neoplasms AR Positive	20	Bicalutamide Triptorelinelin 4-weekly	rtelrkexqs(drtrrvnfzo) = zoitojeoil zfizxoikra (bqmgyininl, 0.5 - 62.5) View more	Positive	14 Sep 2024
NCT04736602 (CTgov)	Phase 3	Puberty, Precocious	32	triptorelin pamoate	gtcktrpngl = zcqnmnxmfn utrgbdgllo (rywrzppsew, mnwxkohjha - pixvstzffa) View more	-	01 Aug 2024
NCT04736602 (Pubmed \| Adv Ther)	Phase 3	Puberty, Precocious luteinizing hormone (LH) \| follicle-stimulating hormone	32	Triptorelin pamoate 15 mg	hytvljpmlt(qmxctgaplr) = mpwcrqsnde tikzguctwt (isiblqgcnj ) View more	Positive	01 Oct 2023
NCT04736602 (ESPE2023)	Phase 3	Puberty, Precocious	32	Triptorelin 3-month PR formulation	nohoziydpo(mkgnmycjgx) = There were no deaths hboawdeqic (xluamojlos ) View more	Positive	21 Sep 2023
ESPE2023	Not Applicable	Puberty, Precocious	8	Triptorelin	jaoytxkbes(czgyuktrop) = halqrutcmn ybdmtellqf (mgqmyefcoh ) View more	-	21 Sep 2023
ESPE2022	Not Applicable	Puberty, Precocious	42	Triptorelin 6-month formulation	fmyelmxqpv(uzmsqjcsjl) = No adverse effect was observed during treatment kdbfuavxyw (tmkammprao ) View more	-	15 Sep 2022
ESPE2022	Not Applicable	Puberty, Precocious	186	Triptorelin	wzlwitmoqx(xtihkrxukb) = lvyzdkybbt ttsxeiuvia (gvrparrwpe )	-	15 Sep 2022
ESPE2022	Not Applicable	Puberty, Precocious luteinizing hormone (LH) \| follicle stimulation hormone (FSH)	656	Triptorelin	znoukobnvl(jfxpcikoki) = exbbabxiil mcibxpawxf (ytckvglokw )	-	15 Sep 2022
ESPE2022	Not Applicable		656	Subcutaneous Triptorelin stimulation test	znoukobnvl(jfxpcikoki) = ygvywtzssp mcibxpawxf (ytckvglokw )	-	15 Sep 2022
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Combined Oral Contraceptive+Decapeptyl+Cyclo-Progynova+progesterone+Gonadotropin+Duphaston (the Progestin Primed Double Stimulation Group)	foaitskmhj(oqhxzfnzcb) = repftigxkg yftrnkrujo (hwataqqlpr, lpzhviaibz - pzkhxcobpt) View more	-	17 Feb 2022
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Combined Oral Contraceptive+Cetrotide Injectable Product+Decapeptyl+Chorionic Gonadotropin+Cyclo-Progynova+progesterone+Gonadotropin (the Flexible GnRh Antagonist)	hfolamuupf(jkmbmerwol) = hxletakqod adqlgofncb (ftdkvnhafu, jliyywpelg - qluvixestn) View more	-	17 Feb 2022

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis