Leuprolide Acetate API manufacturer
Product Code: 4008634 Product Code GMP: H-4060-GMP
Key information
Regulatory documentation
DMF: available
Chemical identifiers
CAS Number(s):
- 53714-56-0 (net)
- 74381-53-6 (acetate)
Synonyms:
- Leuprorelin
- (Des-Gly10,D-Leu6,Pro-NHEt9)-LHRH
- Leuprorelina
- Leuprorelina acetato
- Leuproreline
Sequence
Pyr-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt acetate salt
Fields of application
Leuprolide is used to manage hormone‑dependent conditions by suppressing the body’s production of sex hormones. Its key applications include prostate cancer, endometriosis, uterine fibroids, and central precocious puberty, where controlled hormone reduction provides therapeutic benefit.
Molecular information
Molecular formula:
C59H84N16O12
Relative molecular mass:
1209.5 (net)
Long-term storage:
-20 ± 5°C
Discover how we use synergies to improve Leuprolide production
Find more relevant information on Goserelin, Leuprorelin and Triptorelin and our unique synthesis approach, that ensures economies of scale for API manufacturing.
Certificate of Suitability (CEP)
Leuprolide Acetate Ph. Eur.
Certificates granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM) for our peptide APIs.
Why choose Bachem as your Leuprolide supplier
Leading relin expertise
Bachem manufactures hundreds of kilograms of GMP grade gonadorelin analogs each year, backed by decades of specialized peptide experience.
Efficient LPPS production
Leuprolide is produced via optimized liquid-phase peptide synthesis, ensuring robust, efficient, and sustainable manufacturing.
Strong regulatory support
Customers benefit from readily available DMFs, CEPs, and expert regulatory guidance that accelerates global registrations.
Reliable supply chain
Bachem offers fast delivery from stock, secure supply, and comprehensive impurity management for smooth operations.
Innovation driven quality
Continuous process improvements enhance efficiency, resilience, and sustainability across all relin products.
Customer-centric service
A dedicated team supports customers with documentation, impurity catalogs, and end-to-end service designed to simplify workflows.
Driving generic drugs together
Rely on our years of experience in manufacturing Leuprolide and other APIs for your next commercial drug venture.
Related impurities
| Product Number | Name | Sequence |
|---|---|---|
|
(Des-Gly¹⁰,D-Leu⁶,Orn⁸,Pro-NHEt⁹)-LHRH |
Pyr-His-Trp-Ser-Tyr-D-Leu-Leu-Orn-Pro-NHEt |
|
|
(Des-Gly¹⁰,Des-Ser⁴,D-Leu⁶,Pro-NHEt⁹)-LHRH |
Pyr-His-Trp-Tyr-D-Leu-Leu-Arg-Pro-NHEt |
|
|
(Des-Gly¹⁰,D-His²,D-Leu⁶,Pro-NHEt⁹)-LHRH |
Pyr-D-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt |
|
|
(Des-Gly¹⁰,D-Leu⁶,D-Leu⁷,Pro-NHEt⁹)-LHRH |
Pyr-His-Trp-Ser-Tyr-D-Leu-D-Leu-Arg-Pro-NHEt |
|
|
(Des-Gly¹⁰,Leu⁶,Pro-NHEt⁹)-LHRH |
Pyr-His-Trp-Ser-Tyr-Leu-Leu-Arg-Pro-NHEt |
|
|
(Des-Gly¹⁰,D-Leu⁶,Pro-NHEt⁹)-LHRH |
Pyr-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt |
|
|
(Des-Gly¹⁰,D-Leu⁶,[¹³C₆]Leu⁷,Pro-NHEt⁹)-LHRH |
Pyr-His-Trp-Ser-Tyr-D-Leu-[¹³C₆]Leu-Arg-Pro-NHEt |
|
|
(Des-Gly¹⁰,D-Pyr¹,D-Leu⁶,Pro-NHEt⁹)-LHRH |
D-Pyr-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt |
|
|
(Des-Gly¹⁰,D-Ser⁴,D-Leu⁶,Pro-NHEt⁹)-LHRH |
Pyr-His-Trp-D-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt |
|
|
(Des-Gly¹⁰,Ser(Ac)⁴,D-Leu⁶,Pro-NHEt⁹)-LHRH |
Pyr-His-Trp-Ser(Ac)-Tyr-D-Leu-Leu-Arg-Pro-NHEt |
|
|
(Des-Gly¹⁰,D-Trp³,D-Leu⁶,Pro-NHEt⁹)-LHRH |
Pyr-His-D-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt |
|
|
(Des-Gly¹⁰,D-Tyr⁵,D-Leu⁶,Pro-NHEt⁹)-LHRH |
Pyr-His-Trp-Ser-D-Tyr-D-Leu-Leu-Arg-Pro-NHEt |
|
|
(D-Leu⁶)-LHRH (1-8) (free acid) |
Pyr-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-OH |
|
|
(D-Leu⁶,Pro-NHEt⁹)-LHRH (4-9) |
H-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt |
|
|
LHRH (1-5) (free acid) |
Pyr-His-Trp-Ser-Tyr-OH |
Additional information on Leuprolide
What is leuprolide acetate?
Leuprolide, also known as leuprorelin, is a synthetic agonist analog of gonadotropin-releasing hormone (GnRH), repressing expression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). It is used to treat prostate cancer, breast cancer, endometriosis, uterine fibroids and central precocious puberty (CPP). Leuprolide is a short peptide consisting of nine amino acids.
How does leuprolide work? Leuprolide mechanism of action (MOA)
Leuprolide is a synthetic analog of GnRH, a hormone produced by the hypothalamus in the brain. Leuprolide MOA regulates the production of sex hormones, including luteinizing hormone (LH) and follicle-stimulating hormone (FSH).
When applied as subcutaneous injection, leuprolide MOA initially start with the stimulation of the pituitary gland in the brain to release LH and FSH, just like natural GnRH. This stimulation prompts the pituitary gland to release LH and FSH, which are the messengers that signal the testes in males and the ovaries in females to produce sex hormones, such as testosterone and oestradiol.
However, with continued administration of leuprolide, a process known as “downregulation” occurs. This means that the pituitary gland becomes less responsive to the constant GnRH-like signals generated by leuprolide.
Stimulation in the pituitary gland releases LH and FSH just like natural GnRH
As a result of this desensitization, LH and FSH production by the pituitary gland decreases over time. Since LH and FSH are crucial for stimulating the production of sex hormones, their reduction leads to a significant decrease in the production of testosterone in males and oestradiol in females.
Ultimately, the diminished production of sex hormones leads to a state of hypogonadism, where the levels of testosterone or oestradiol in the body drops significantly below the normal range. This controlled reduction of sex hormones is the desired therapeutic outcome in various conditions. For example, in prostate cancer, lowering testosterone levels can slow the growth of cancer cells, while in conditions like endometriosis and uterine fibroids, it can reduce symptoms associated with excess oestradiol.
What are the applications of leuprolide?
Initially marketed as a daily injection in 1985, a new long-acting formulation was developed and commercialized four years later for monthly injection. Leuprolide is now sold under different brand names:
| Company | Molecule | Branded Product | Dosage / Strength | Indication |
|---|---|---|---|---|
|
Takeda |
Leuprolide acetate |
Enantone® |
|
Prostate cancer |
|
Abbvie |
Leuprolide acetate |
Lupron Depot® |
Endometriosis & uterine fibrosis:
Prostate cancer:
CPP:
|
|
|
Recordati/Tolmar |
Leuprolide acetate |
Eligard® |
|
Prostate cancer |
|
Tolmar |
Leuprolide acetate |
Fensolvi® |
45 mg (6-month) |
CPP |
|
Accord BioPharma/Foresee |
Leuprolide mesylate |
Camcevi® |
42 mg (6-month) |
Prostate cancer |
A new salt form has been developed, leuprolide mesylate, and is sold under the brand name Camcevi®. This new form is the first-ever ready-to-inject sterile formulation of leuprolide mesylate and comes in a pre-filled syringe, where no mixing is required anymore.
How is leuprolide produced?
With our long experience in GMP-grade peptides, we manufacture and supply hundreds of kilograms of high-quality gonadorelin (LHRH) analogs or so-called relins each year via liquid-phase peptide synthesis (LPPS).
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