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Leuprorelin - Foresee Pharmaceuticals/ScinoPharma

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Drug Profile

Leuprorelin - Foresee Pharmaceuticals/ScinoPharma

Alternative Names: Camcevi; FP-001; FP-001 LMIS; FP-001/LMIS; leuprolide controlled-release - Foresee/ScinoPharma; Leuprolide Mesylate - Foresee/ScinoPharma; Leuprolide mesylate injectable suspension - Foresee Pharmaceuticals; LMIS - Foresee Pharmaceuticals

Latest Information Update: 16 Mar 2026

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At a glance

  • Originator Foresee Pharmaceuticals - ScinoPharm (JV)
  • Developer Foresee Pharmaceuticals - ScinoPharm (JV); GeneScience Pharmaceuticals
  • Class Antineoplastics; Gonadotropins; Oligopeptides; Pituitary hormone releasing hormones
  • Mechanism of Action Gonadotropin releasing hormone stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Prostate cancer
  • Phase III Breast cancer; Precocious puberty

Most Recent Events

  • 06 Mar 2026 Accord Healthcare announces its intention to receive final decision from EC regarding marketing authorisation for 3-month version of leuprorelin for prostate cancer (SC), in the second quarter of 2026
  • 06 Mar 2026 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issues a positive opinion and recommends marketing authorisation approval of 3-month version of leuprorelin for Prostate cancer (Late-stage disease)
  • 06 Mar 2026 Foresee Pharmaceuticals submits MAA to the European Medicines Agency (EMA) for 3-month version of leuprorelin for Prostate cancer (Late-stage disease), prior to March 2026

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