Leuprolide acetate SR is under clinical development by AbbVie and currently in Phase II for Kidney Disease (Nephropathy). According to GlobalData, Phase II drugs for Kidney Disease (Nephropathy) have a 40% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Leuprolide acetate SR’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Leuprolide acetate SR overview

Leuprolide acetate (Tapros, Tapros 3M Depot, Lupron Depot, Lucrin Depot, Lucrin, Procrin, Prostap SR DCS, Lupron Depot-PED, Leuplin PRO and Enantone, Prostap PD DCS, Enantone-Gyn Monats-Depot, Enantone Monats-Depot, Lucrin PDS Depot, Sixantone, Trenantone, Enantone-Gyn Depot, Leuplin, Prostap 3 DCS, Lupron, Lucrin Depot PDS, Lucrin XL Depot, Ginecrin Depot, Procrin Trimestral, Procrin Semestral, Procrin Mensual, Procrin Depot, Enantone LP ) is an gonadotropin-releasing hormone (GnRH) analog. It is formulated capsules for oral,solution and lyophilized powder for suspension for  subcutaneous and intramuscular administration. It is indicated in the palliative treatment of advanced prostatic cancer, advanced breast cancer, endometriosis, including pain relief and reduction of endometriotic lesions. Concomitantly with iron therapy is indicated for the preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata. Leuplin PRO indicated for the treatment of prostate cancer and premenopausal breast cancer. Lupron Depot-PED is indicated in the treatment of children with central precocious puberty (CPP). Lupron Depot 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30  mg for 4 – month administration, and 45 mg for 6-month administr ation (leuprolide acetate) are indicated in the palliative treatment of advanced prostatic cancer. Prostap SR DCS is indicated for metastatic prostate cancer, locally advanced prostate cancer, as an alternative to surgical castration, as an adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer, as an adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression, as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer, management of endometriosis, including pain relief and reduction of endometriotic lesions, endometrial preparation prior to intrauterine surgical procedures including endometrial ablation or resection, preoperative management of uterine fibroids to reduce their size and associated bleeding.

It is under development for the treatment of autosomal dominant polycystic liver disease, autosomal dominant polycystic kidney disease.

It was under development for the treatment of spinal and bulbar muscular atrophy (SBMA). It is a sustained release formulation.

AbbVie overview

AbbVie is a specialty biopharmaceutical company, which discovers, develops, manufactures, and commercializes drugs for the treatment of chronic and complex diseases. Its drugs are indicated for the treatment of metabolic and rheumatological diseases, neurological disorders, skin diseases, rheumatoid arthritis, pain related to endometriosis, pediatric Crohn’s disease, cancer, and other serious health conditions. AbbVie is also advancing its pipeline programs for the treatment of Crohn’s disease, Parkinson’s disease, viral diseases, wet AMD, various cancers, neurological disorders, aesthetics, and other autoimmune diseases. The company markets its products directly to wholesalers, distributors, health care facilities, government agencies, specialty pharmacies and independent retailers through its own distribution centers and public warehouses worldwide. AbbVie is headquartered in North Chicago, Illinois, the US.

For a complete picture of Leuprolide acetate SR’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.