Gonadorelin Acetate

Sold as Lutrepulse. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Gonadorelin Acetate (sold as Lutrepulse), first approved Oct 10, 1989, with 0 new uses approved and 0 published complete response letters.

First approved: Oct 10, 1989
Applications: 1
New uses approved: 0
Complete response letters: 0

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

For induction of ovulation in women with hypothalamic amenorrhea due to a deficiency or absence in the quantity or…Ferring Laboratories, Inc. · designated Apr 22, 1987 · approved Oct 10, 1989

Clinical Trials

87 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal RespondersICSI, IVF · Al-Azhar University	Not applicable	Recruiting	Oct 6, 2026
Phase Ia Trial of HHK001 Compared With Enantone in Patients With EndometriosisEndometriosis · Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.	Phase 1	Recruiting	Aug 10, 2026
Trifecta Research StudyPTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction · Axial Therapeutic Research	—	Active, not recruiting	Jul 21, 2026
Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE TrialRecurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 · Mayo Clinic	Phase 2	Recruiting	Jun 16, 2026
Clinical Study on the Preservation of Ovarian Function Following Autologous Hematopoietic Stem Cell Transplantation Using GoserelinOvarian Insufficiency, Autologous Hematopoietic Stem Cell Transplantation · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Not applicable	Not yet recruiting	Apr 27, 2026
Clinical Study on the Preservation of Ovarian Function Following Hematopoietic Stem Cell Transplantation in Patients With Malignant Hematologic Diseases Using GoserelinAllogeneic Haematopoietic Stem Cell Transplantation, Malignant Hematologic Disease · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Not applicable	Not yet recruiting	Apr 27, 2026
Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer PatientsAnatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8 · Mayo Clinic	Phase 2	Recruiting	Mar 10, 2026
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CTProstate Cancer, Localized Prostate Carcinoma · Baptist Health South Florida	Phase 2	Recruiting	Mar 6, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Oct 10, 1989	LutrepulseNDA 19687 · New active ingredient	Ferring	9	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA