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

1,800

Literatures (Medical) associated with Triptorelin Pamoate

24 May 2025·Cureus Journal of Medical Science

Uterine Inflammatory Myofibroblastic Tumor Mimicking Myoma Treated With Gonadotropin-Releasing Hormone Therapy: A Case Report

Article

Author: Nakatani, Kimiko ; Hirano, Koki ; Yorita, Kenji

Inflammatory myofibroblastic tumors (IMTs) of the uterus are a rare entity that can be challenging to distinguish from leiomyomas, both radiologically and pathologically. No previous reports have documented the response of uterine IMT to gonadotropin-releasing hormone (GnRH) therapy. A 47-year-old Japanese woman presented to our hospital with excessive menstruation and uterine prolapse. Magnetic resonance imaging (MRI) revealed four well-demarcated uterine masses, with the largest measuring 81 mm. Myomas were suspected. Oral GnRH therapy was initiated to relieve the symptoms and reduce the preoperative volume. After four months, follow-up MRI showed a reduction in the largest mass to 62 mm and increased hyperintense areas on T2-weighted images. At six months, the patient underwent laparoscopic hysterectomy and colporrhaphy. Histopathological examination revealed that the largest tumor was an IMT with abundant myxoid matrix, positive for anaplastic lymphoma kinase (ALK), and ALK gene rearrangement. The remaining three masses were diagnosed as usual-type leiomyomas. This is the first reported case of uterine IMT treated with GnRH therapy, which resulted in notable tumor shrinkage. This case highlights both the potential therapeutic approach for uterine IMT and the diagnostic difficulty in distinguishing it from leiomyomas preoperatively.

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.

News (Medical) associated with Triptorelin Pamoate

04 Sep 2025

·www.debiopharm.com

Debiopharm’S Pamorelin® Receives Swiss Approval for subcutaneous Administration, Enhancing Treatment Flexibility for Prostate Cancer Patients

Swissmedic has approved subcutaneous administration of Pamorelin® LA 3.75 mg and 11.25 mg for prostate cancer treatment Lausanne, Switzerland – September 4th, 2025 – Debiopharm (www.debiopharm.com), an independently-owned Swiss biopharmaceutical company committed to developing tomorrow’s standard-of-care treatments to cure cancer and infectious diseases, announced that Swissmedic approved, as of May 16, 2025, the subcutaneous administration of Pamorelin® LA 3.75 mg and Pamorelin® LA 11.25 mg (triptorelin embonate) for the treatment of prostate cancer. This new administration route complements the doses already approved for intramuscular injection (3.75mg, 11.25mg and 22.5mg). Subcutaneous administration of Pamorelin® has demonstrated equivalent efficacy and safety compared to the well-established intramuscular route¹,². A comfortable and flexible alternative for patients and healthcare professionals, in general, the subcutaneous injection is less painful, better tolerated by patients on anticoagulants, reduces the risk of hematoma, and is ideal for individuals with low muscle mass or those who are averse to intramuscular injections. For healthcare professionals, it offers the same efficacy and safety as intramuscular administration, with no changes to dosing schedules, storage conditions, or preparation requirements. This allows seamless integration into existing protocols. Having both options enables tailoring treatment to each patient’s profile and preferences, supporting a more personalized approach. Prostate cancer is the most common cancer among men in Switzerland, with an average of 7,827 new cases and 1,356 deaths annually³,⁴. The medical care of these patients highlights the critical need for better-tolerated and more comfortable treatment options to improve the quality of life of patients throughout their care journey. “ This is great news for men facing prostate cancer in Switzerland. This approval marks a meaningful step towards more personalized and practical care for patients, giving healthcare professionals the flexibility to adapt administration to individual patient needs and clinical settings”, said Catalin Tamas, Head of Medical Affairs at Debiopharm. “Continuous development of new, long-acting-release formulations of triptorelin, reflects our commitment to advancing prostate cancer care, addressing the evolving clinical needs in the management of this disease.” Already approved in several other countries, this new administration option enhances flexibility by allowing healthcare providers to tailor treatment based on clinical needs, institutional practices, and individual patient preferences. Updated product information for Pamorelin® LA 3.75 mg and 11.25 mg is available at https://www.swissmedicinfo.ch Pamorelin® is a GnRH agonist used in the treatment of prostate cancer. Debiopharm has developed three long-acting formulations (1-, 3-, and 6-month) of triptorelin pamoate and is currently developing a 12-month formulation. Triptorelin is manufactured in Switzerland at Debiopharm’s production site in Martigny and is marketed in Switzerland by Debiopharm and in over 80 countries through selected big pharmaceutical partners. It is a market leader and reference treatment in many regions worldwide. Debiopharm aims to develop innovative treatments that address high unmet medical needs, primarily in oncology and bacterial infections. Bridging the gap between breakthrough discoveries and real-world patient access, the company identifies high-potential molecules and technologies for licensing, clinically demonstrates their safety and efficacy, and partners with major pharmaceutical companies to ensure global patient access. For more information, visit https://www.debiopharm.com Follow us on LinkedIn: https://www.linkedin.com/company/debiopharminternational/ 1 Klippel K, Winkler, C, Jocham D. et al. Efficacy and tolerability of 2 application forms (s.c. and i.m.) of Decapeptyl® depot in patients with advanced prostate cancer. Urologe A 1999;38(3):270-275. 2 Lebret T, Rouanne M, Hublarov O, Jinga V, Petkova L, Kotsev R, Sinescu I, Dutailly P. Efficacy of triptorelin pamoate 11.25 mg administered subcutaneously for achieving medical castration levels of testosterone in patients with locally advanced or metastatic prostate cancer. Ther Adv Urol 2015 Jun;7(3):125-34. 3 https://krebs-monitoring.bfs.admin.ch/fr/comparaison/nouveaux-cas/ 4 https://krebs-monitoring.bfs.admin.ch/fr/comparaison/deces/

Drug Approval

29 Aug 2025

·www.einpresswire.com

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

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

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	Beaufour-Ipsen (Tianjin) Pharmaceutical Co., Ltd.	28 Jul 2017
Endometriosis	Phase 3	China	Ipsen Pharma SAS	28 Jul 2017
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
Advanced Prostate Carcinoma	Phase 3	Latvia	Ipsen SA	01 Nov 2009
Advanced Prostate Carcinoma	Phase 3	Lithuania	Ipsen SA	01 Nov 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05590793 (CTgov)	Phase 3	Advanced Prostate Carcinoma	195	Triptorelin Pamoate	qiojcwqecj = vblfdxkonx opdhykxjnh (uphnubahno, nixtfnodha - jbavqzpmsy) View more	-	09 Sep 2025
NCT05458856 (TriptoSwitch, CTgov)	Phase 3	Metastatic Prostate Carcinoma	147	Triptorelin Embonate	zptxklscgs = ugkwaopesn swnhiymxrh (nbcikahxra, cqrgrtqxff - csjbqmetfk) View more	-	23 Jul 2025
NCT05029622 (Pubmed \| Adv Ther)	Phase 3	Puberty, Precocious	66	Triptorelin pamoate 22.5 mg	jslbuarxkc(uvcyyktuad) = Thirteen patients (19.7%) had 22 drug-related treatment emergent adverse events (TEAEs); no grade ≥ 3 TEAEs were reported cmanvlqnsx (klicwhssil ) View more	Positive	01 Dec 2024
ESMO2024 Manual	Not Applicable	AR Positive Salivary Gland Neoplasms AR Positive	20	Bicalutamide Triptorelinelin 4-weekly	gahpfnbfgw(csjknzyjkd) = iwfmrptjac mykeltjidz (arvfundhax, 0.5 - 62.5) View more	Positive	14 Sep 2024
NCT04736602 (CTgov)	Phase 3	Puberty, Precocious	32	triptorelin pamoate	vxiukicyiy = vowuvlfkol sojbkqqgun (jqwjlmsrqa, fyzaxyvfvb - uvefblcbww) View more	-	01 Aug 2024
NCT04736602 (Pubmed \| Adv Ther)	Phase 3	Puberty, Precocious luteinizing hormone (LH) \| follicle-stimulating hormone	32	Triptorelin pamoate 15 mg	nrfqrvbfhp(caxdybpkld) = merreswymr biczlihtsb (yytwwpherr ) View more	Positive	01 Oct 2023
NCT04736602 (ESPE2023)	Phase 3	Puberty, Precocious	32	Triptorelin 3-month PR formulation	lkcyzwaaut(qljwueeigl) = There were no deaths vploucchql (zogpyhygqt ) View more	Positive	21 Sep 2023
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Gonadotropin+Decapeptyl+Cyclo-Progynova+progesterone+Duphaston (the Progestin Primed Double Stimulation Group)	zvpmsuqpao(lydikykwaw) = xajdlhfvsc tzbfvvyhid (rmicrmvttd, oniteqbqtt - zdtrogqptp) View more	-	17 Feb 2022
NCT04537078 (CTgov)	Phase 3	Infertility, Female	90	Chorionic Gonadotropin+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone (the Flexible GnRh Antagonist)	etehpprtzk(xfnqsyflnh) = fnowzfkamh xwnhqbdbwr (pifijnijab, fwiaqwbbss - jekglmlgpx) View more	-	17 Feb 2022
NCT03232281 (CTgov)	Phase 3	Endometriosis	300	Triptorelin Pamoate (Triptorelin Pamoate PR 3-month)	raefjfdbky = elzjahwrqo okfkizjnhs (egppuwushp, ixdlcuurtc - vzaylkvwae) View more	-	14 Oct 2021
NCT03232281 (CTgov)	Phase 3	Endometriosis	300	Triptorelin Acetate (Triptorelin Acetate PR 1-month)	raefjfdbky = amvucclwzn okfkizjnhs (egppuwushp, hyumxxbbah - owgmkvqxtq) View more	-	14 Oct 2021
NCT00311636 (PROMISE-GIM6, ASCO2021)	Phase 3	Early Stage Breast Carcinoma Adjuvant	281	CT+GnRHa	uqjjjpmdez(jcqnmvabxb) = mfvzjmicmk etqolyumtf (wmmbxogabn ) View more	Positive	28 May 2021
NCT00311636 (PROMISE-GIM6, ASCO2021)	Phase 3	Early Stage Breast Carcinoma Adjuvant	281	CT alone	uqjjjpmdez(jcqnmvabxb) = lohqgkirll etqolyumtf (wmmbxogabn ) View more	Positive	28 May 2021

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