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Diethylstilbestrol | CAS No: 56-53-1 | GMP-certified suppliers
A medication that supports management of prostate cancer by providing estrogenic therapy in limited clinical settings where hormonal suppression offers therapeutic benefit.
Therapeutic categories
Primary indications
- Used in the treatment of prostate cancer
- Previously used in the prevention of miscarriage or premature delivery in pregnant women prone to miscarriage or premature delivery
Product Snapshot
- Diethylstilbestrol is an oral and intravenous small‑molecule estrogen available in liquid and tablet formulations
- It is used primarily for prostate cancer, with historical use in pregnancy no longer practiced
- Its regulatory status includes past approval and subsequent withdrawal or investigational classification in markets such as Canada
Clinical Overview
Pharmacologically, diethylstilbestrol exhibits potent estrogen receptor agonism. The molecule diffuses into target cells, binds to estrogen receptors, and modulates transcription of estrogen‑responsive genes. Physiologic effects include increased hepatic synthesis of sex hormone binding globulin, thyroid‑binding globulin, and multiple serum proteins. Feedback suppression of follicle‑stimulating hormone and downstream reduction in gonadotropin‑releasing hormone secretion contribute to its endocrine activity. These mechanisms underpin both antineoplastic effects in androgen‑dependent malignancies and the broad systemic hormonal actions associated with estrogen therapy.
Absorption, distribution, metabolism, and excretion characteristics are influenced by extensive hepatic metabolism, including pathways involving cytochrome P450 isozymes such as CYP2C8, CYP2C9, CYP2E1, and CYP3A. Diethylstilbestrol is also a substrate or inhibitor of several transporters, including BCRP, BSEP, OATP1B1, OATP2B1, and P‑glycoprotein. Such interactions create potential for altered exposure of co‑administered substrates. The compound exhibits prolonged biological activity due to high receptor affinity and enterohepatic circulation.
Safety considerations include carcinogenicity, thromboembolic risk, endocrine disruption, and reproductive toxicity. Historical concerns over transplacental carcinogenesis remain the defining safety issue. Use requires careful risk–benefit assessment, particularly in populations with preexisting thrombotic or estrogen‑sensitive conditions.
Diethylstilbestrol is no longer widely marketed, and historical branded forms have been discontinued. For API procurement, sourcing should prioritize documented control of impurities associated with synthetic stilbene estrogens, validated absence of cross‑contaminants, and full traceability to support regulatory review in jurisdictions where limited clinical use persists.
Identification & chemistry
| Generic name | Diethylstilbestrol |
|---|---|
| Molecule type | Small molecule |
| CAS | 56-53-1 |
| UNII | 731DCA35BT |
| DrugBank ID | DB00255 |
Pharmacology
| Summary | Diethylstilbestrol is a synthetic estrogen that activates estrogen receptors, influencing gene transcription in reproductive tissues, the hypothalamic‑pituitary axis, and the liver. Receptor engagement increases hepatic production of binding proteins and suppresses FSH and GnRH signaling, leading to broad inhibition of gonadotropin-driven processes. Its pharmacodynamic effects reflect augmentation of estrogenic activity, historically applied across hormone‑responsive conditions. |
|---|---|
| Mechanism of action | Estrogens diffuse into their target cells and interact with a protein receptor, the estrogen receptor. Target cells include the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary. The effect of Estrogen binding their receptors causes downstream increases the hepatic synthesis of sex hormone binding globulin (SHBG), thyroid-binding globulin (TBG), and other serum proteins and suppress follicle-stimulating hormone (FSH) from the anterior pituitary. The combination of an estrogen with a progestin suppresses the hypothalamic-pituitary system, decreasing the secretion of gonadotropin-releasing hormone (GnRH). |
| Pharmacodynamics | Diethylstilbestrol is a synthetic estrogen that was developed to supplement a woman's natural estrogen production. In 1971, the Food and Drug Administration (FDA) issued a Drug Bulletin advising physicians to stop prescribing DES to pregnant women because it was linked to a rare vaginal cancer in female offspring. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Estrogen receptor beta | Humans | agonist |
| Estrogen receptor alpha | Humans | agonist |
| Estrogen-related receptor gamma | Humans | agonist |
ADME / PK
| Metabolism | Hepatic. |
|---|
Formulation & handling
- Low aqueous solubility and high lipophilicity indicate dissolution‑limited absorption for oral tablets, often requiring solubilizing excipients.
- IV formulations require cosolvent or surfactant systems to achieve suitable solubility and maintain physical stability.
- As a potent synthetic estrogen in solid form, handling typically requires containment to limit occupational exposure.
Regulatory status
| Lifecycle | Patent protection for the API in Canada appears to be approaching or past expiry, indicating a transition toward a more mature market. As exclusivity ends, the Canadian market is likely to move toward increased generic participation and greater price competition. |
|---|
| Markets | Canada |
|---|
Supply Chain
| Supply chain summary | Diethylstilbestrol has legacy involvement from several historical originator companies, with additional smaller manufacturers and a packager supporting limited ongoing supply. Current branded products appear confined to the Canadian market, with no evidence of active US or EU commercial presence. Patent protection has long expired, so any remaining availability reflects a mature landscape in which only niche or legacy generic offerings persist. |
|---|
Safety
| Toxicity | Symptoms of overdose include nausea and vomiting, and withdrawal bleeding may occur in females. |
|---|
- Overexposure may elicit dose‑dependent gastrointestinal effects such as nausea and emesis
- Appropriate controls should be used to limit inhalation or dermal contact
- Hormonal activity can trigger withdrawal bleeding in exposed females
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Diethylstilbestrol is a type of Estrogens
Estrogens are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in hormone therapy and women's health. Estrogens are a class of steroidal compounds that are primarily produced in the ovaries and play a significant role in the development and maintenance of female reproductive tissues and secondary sexual characteristics. These APIs are widely used in various pharmaceutical formulations, including oral contraceptives, hormone replacement therapies, and treatments for menopausal symptoms. They are also utilized in the management of conditions such as hypogonadism, infertility, and certain types of cancer.
Estrogens exert their effects by binding to estrogen receptors, which are present in various tissues throughout the body. This binding initiates a cascade of cellular and molecular events that regulate gene expression and modulate physiological processes.
Some common examples of estrogens used in pharmaceutical formulations include estradiol, estrone, and estriol. These compounds are typically synthesized from natural sources or derived from plant-based substances through a series of chemical reactions and purification processes.
As with any pharmaceutical API, the production of estrogens follows strict quality control guidelines to ensure purity, potency, and safety. Stringent regulatory standards and rigorous testing protocols are employed to guarantee consistent quality and adherence to pharmaceutical industry regulations.
In conclusion, estrogens are a vital subcategory of pharmaceutical APIs with a wide range of applications in women's health and hormone therapy. Their role in maintaining hormonal balance and addressing various medical conditions underscores their importance in modern medicine.
Diethylstilbestrol (Estrogens), classified under Hormonal Agents
Hormonal agents are a prominent category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These substances play a crucial role in regulating and modulating hormonal functions within the body. Hormonal agents are designed to mimic or manipulate the effects of naturally occurring hormones, allowing healthcare professionals to treat various endocrine disorders and hormonal imbalances.
Hormonal agents are commonly employed in the treatment of conditions such as hypothyroidism, hyperthyroidism, diabetes, and hormonal cancers. These APIs work by interacting with specific hormone receptors, either by stimulating or inhibiting their activity, to restore the balance of hormones in the body. They can be administered orally, intravenously, or through other routes depending on the specific medication and patient needs.
Pharmaceutical companies employ rigorous manufacturing processes and quality control measures to ensure the purity, potency, and safety of hormonal agent APIs. These APIs are synthesized using chemical or biotechnological methods, often starting from natural hormone sources or through recombinant DNA technology. Stringent regulatory guidelines are in place to guarantee the efficacy and safety of hormonal agent APIs, ensuring that patients receive high-quality medications.
As the demand for hormone-related therapies continues to grow, ongoing research and development efforts focus on enhancing the effectiveness and reducing the side effects of hormonal agent APIs. This includes the exploration of novel delivery systems, advanced formulations, and targeted drug delivery methods. By continuously advancing our understanding and capabilities in hormonal agents, the medical community can improve patient outcomes and quality of life for individuals with hormonal disorders.
Diethylstilbestrol API manufacturers & distributors
Compare qualified Diethylstilbestrol API suppliers worldwide. We currently have 1 companies offering Diethylstilbestrol API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Weijie Pharmaceuticals | Producer | China | China | CoA, USDMF | 15 products |
When sending a request, specify which Diethylstilbestrol API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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