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Dutasteride | CAS No: 164656-23-9 | GMP-certified suppliers
A medication that treats symptomatic benign prostatic hyperplasia by improving urinary symptoms and lowering the risk of acute urinary retention and related surgical intervention.
Therapeutic categories
5-alpha Reductase InhibitorsAdrenergic alpha-AntagonistsAdrenergic AntagonistsAgents that produce hypertensionAzasteroidsCytochrome P-450 CYP3A Substrates
Generic name
Dutasteride
Molecule type
small molecule
CAS number
164656-23-9
DrugBank ID
DB01126
Approval status
Approved drug, Investigational drug
ATC code
G04CB02
Primary indications
- Indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland to improve symptoms, and reduce the risk of acute urinary retention and the need for BPH-related surgery alone or in combination with [tamsulosin]
Product Snapshot
- Dutasteride is an oral small‑molecule API primarily supplied in capsule and liquid‑filled capsule formats, with some topical presentations in development
- It is used for management of benign prostatic hyperplasia to support symptom reduction and lower the risk of progression events
- It holds approved status in the US and Canada, with additional investigational use in some markets
Clinical Overview
Dutasteride (CAS 164656-23-9) is an oral synthetic 4-azasteroid indicated for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate. It is used to improve lower urinary tract symptoms and reduce the risk of acute urinary retention or the need for surgery. It may be administered as monotherapy or in combination with tamsulosin. Avodart is a widely recognized brand. Although dutasteride has been studied in androgenetic alopecia, it is not formally approved for this indication.
Dutasteride is a dual inhibitor of the type I and type II 5α-reductase isoenzymes responsible for converting testosterone to dihydrotestosterone. By inhibiting both isoforms, it achieves near-complete suppression of circulating dihydrotestosterone. Reduction in dihydrotestosterone is dose dependent, with maximal suppression observed within one to two weeks of daily 0.5 mg dosing. Prolonged administration produces sustained reductions exceeding 90 percent in most patients. Decreases in serum prostate‑specific antigen may occur and can complicate cancer detection.
The mechanism involves formation of a stable complex with the 5α-reductase enzymes, inhibiting the enzymatic conversion of testosterone. Dutasteride does not bind to androgen receptors. Suppression of intraprostatic dihydrotestosterone reduces glandular volume and increases epithelial apoptosis, resulting in improved urinary flow.
Dutasteride is extensively metabolized, primarily via CYP3A pathways. It exhibits a long elimination half‑life and high lipophilicity. Accumulation may occur with chronic dosing. Safety considerations include potential sexual adverse effects, breast tissue changes, and the need for caution in liver impairment due to metabolic dependence on CYP3A enzymes. It is contraindicated in pregnancy because of risk to the developing male fetus.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemical integrity, impurity profiles consistent with regulatory expectations, and robust handling practices to ensure stability of this highly lipophilic compound.
Dutasteride is a dual inhibitor of the type I and type II 5α-reductase isoenzymes responsible for converting testosterone to dihydrotestosterone. By inhibiting both isoforms, it achieves near-complete suppression of circulating dihydrotestosterone. Reduction in dihydrotestosterone is dose dependent, with maximal suppression observed within one to two weeks of daily 0.5 mg dosing. Prolonged administration produces sustained reductions exceeding 90 percent in most patients. Decreases in serum prostate‑specific antigen may occur and can complicate cancer detection.
The mechanism involves formation of a stable complex with the 5α-reductase enzymes, inhibiting the enzymatic conversion of testosterone. Dutasteride does not bind to androgen receptors. Suppression of intraprostatic dihydrotestosterone reduces glandular volume and increases epithelial apoptosis, resulting in improved urinary flow.
Dutasteride is extensively metabolized, primarily via CYP3A pathways. It exhibits a long elimination half‑life and high lipophilicity. Accumulation may occur with chronic dosing. Safety considerations include potential sexual adverse effects, breast tissue changes, and the need for caution in liver impairment due to metabolic dependence on CYP3A enzymes. It is contraindicated in pregnancy because of risk to the developing male fetus.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemical integrity, impurity profiles consistent with regulatory expectations, and robust handling practices to ensure stability of this highly lipophilic compound.
Identification & chemistry
| Generic name | Dutasteride |
|---|---|
| Molecule type | Small molecule |
| CAS | 164656-23-9 |
| UNII | O0J6XJN02I |
| DrugBank ID | DB01126 |
Pharmacology
| Summary | Dutasteride is a dual inhibitor of type I and type II 5α‑reductase, blocking the enzymatic conversion of testosterone to the more potent androgen dihydrotestosterone (DHT). By suppressing DHT synthesis in prostate and skin tissues, it reduces androgen‑driven prostate growth and related pathophysiologic signaling. Its pharmacodynamic effect is characterized by substantial and sustained reductions in circulating DHT. |
|---|---|
| Mechanism of action | The 5α-reductase is a nuclear-bound steroid intracellular enzyme primarily located in the prostatic stromal cell that converts the androgen testosterone into the more active metabolite, 5α-dihydrotestosterone (DHT).DHT is considered to be the primary androgen playing a role in the initial development and subsequent enlargement of the prostate gland. It serves as the hormonal mediator for the hyperplasia upon accumulation within the prostate gland.DHT displays a higher affinity towards androgen receptors in the prostate gland compared to testosteroneand by acting on the androgen receptors, DHT modulates genes that are responsible for cell proliferation.Responsible for the synthesis of approximately one-third of circulating DHT, type I 5α-reductase is predominant in the sebaceous glands of most regions of skin, including the scalp, and liver. The type II 5a-reductase isozyme is primarily found in the prostate, seminal vesicles, epididymides, and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT.Due to its dual inhibition of both isoenzymes of 5α-reductase, dutasteride causes a near-complete suppression of DHT.Compared to a 70% reduction of serum DHT levels caused by [finasteride], a near-complete suppression of serum DHT-more than 90% is seen with dutasteride. By forming a stable complex with both type II and type II 5α-reductase, dutasteride inhibits its enzymatic action of converting testosterone to 5α-dihydrotestosterone (DHT), which is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. It is proposed that DHT is the principal androgen responsible for prostatic growth in later life-normal masculinization of the external genitalia and maturation of the prostate gland during development-thus reducing the serum DHT levels results in reduced prostatic volume and increased epithelial apoptosis.Dutasteride is a competitive and specific inhibitor of both Type I and Type II 5α-reductase isoenzymes and when evaluated under _in vitro_ and _in vivo_ conditions, the dissociation of the drug from the drug-enzyme complex is reported to be extremely slow.Dutasteride does not bind to the human androgen receptor. |
| Pharmacodynamics | Dutasteride is a synthetic 4-azasteroid compound that selectively inhibits both the type I and type II isoforms of steroid 5α-reductase, an intracellular enzyme that converts testosterone to 5α-dihydrotestosterone (DHT). Dutasteride works by reducing the levels of circulating DHT. It was also shown to reduce the size of the prostate gland, improve urinary flow, and symptoms of benign prostatic hyperplasia alone or in combination with tamsulosin.The effect of the reduction of DHT by dutasteride is dose-dependent, with the maximum effect observed within 1-2 weeks following initial administration. After 1 and 2 weeks of daily dosing with dutasteride 0.5 mg, median serum DHT concentrations were reduced by 85% and 90%, respectively.The serum concentrations of DHT were maintained to be decreased by more than 90% in 85% of patients following 1 years' administration of oral dutasteride 0.5 mg/day.As evident from the clinical studies, dutasteride may also cause decreases in serum PSA in the presence of prostate cancer. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 3-oxo-5-alpha-steroid 4-dehydrogenase 1 | Humans | inhibitor |
| 3-oxo-5-alpha-steroid 4-dehydrogenase 2 | Humans | inhibitor |
ADME / PK
| Absorption | Following oral administration of a single dose of 0.5 mg dutasteride, the peak serum concentrations were reached within 2 to 3 hours. Following daily oral administration of 0.5 mg dutasteride, the steady-state concentration of 40 ng/mL is expected to be achieved at 6 months following initial administration. In healthy subjects, the absolute bioavailability was 60%, ranging from 40% to 94%. While food intake reduced the maximum serum concentrations by 10 to 15%, food intake is reported to have a negligible effect on the bioavailability of the drug. |
|---|---|
| Half-life | The terminal elimination half-life of dutasteride is approximately 5 weeks at steady state. This long half-life accounts for the serum concentrations remaining detectable for up to 4 to 6 months after discontinuation of treatment. |
| Protein binding | Dutasteride is about 99% bound to albumin and 96.6% bound to α-1 acid glycoprotein in the serum. |
| Metabolism | Dutasteride undergoes extensive hepatic metabolism mediated by CYP3A4 and CYP3A5. 4′-hydroxydutasteride, 6-hydroxydutasteride, 6,4′-dihydroxydutasteride, 1,2-dihydrodutasteride, and 15-hydroxydutasteride metabolites are formed. 2 minor metabolites - 6,4′-dihydroxydutasteride and 15-hydroxydutasteride - can also be detected. According to _in vitro_ studies, 4′-hydroxydutasteride and 1,2-dihydrodutasteride mediated inhibitory actions against both isoforms of 5α-reductase but with lower potency when compared to the parent drug. The activity of 6β-hydroxydutasteride is comparable to that of dutasteride. |
| Route of elimination | Dutasteride and its metabolites mainly undergo fecal excretion. About 1-15% of the dose is excreted as the unchanged parent compound, while 2-90% of the total dose is excreted in the form of dutasteride-related metabolites in the feces. Trace amounts of unchanged dutasteride, with less than 1%, can also be detected in the urine. Therefore, on average, the dose unaccounted for approximated 55%, with a range between 5% and 97%. |
| Volume of distribution | Dutasteride displays a large volume of distribution ranging from 300 to 500 L. Following daily oral administration of 0.5 mg dutasteride healthy subjects for 12 months, the semen dutasteride concentrations averaged 3.4 ng/mL (range: 0.4 to 14 ng/mL) with 11.5% of serum dutasteride concentrations being partitioned into semen. |
| Clearance | In a study of healthy volunteers receiving single oral doses of dutasteride ranging from 0.01 to 40 mg, dutasteride displayed a low linear clearance of 0.58 L/h. The estimated inter-individual variability for the linear clearance was high. |
Formulation & handling
- Lipid‑soluble small molecule with very low aqueous solubility, typically formulated in lipid‑based or soft‑gel systems to enhance oral absorption.
- Oral absorption is not food‑dependent, allowing flexible administration without fed/fasted considerations.
- Chemical stability is generally good in solid state, but handling often favors protected, low‑moisture conditions due to hydrophobicity and capsule‑based delivery formats.
Regulatory status
| Lifecycle | The API’s key U.S. and Canadian patents expired between 2013 and 2015, indicating that exclusivity has lapsed in both markets. With products marketed in the United States and Canada, the ingredient is positioned in a mature stage of its lifecycle. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Dutasteride was originally developed by a single originator, with numerous packagers and distributors now handling finished‑dose supply. Branded and generic products are established in the US and Canada, reflecting wide post‑patent availability. Patent expiries between 2013 and 2015 indicate that generic competition is already well established in these markets. |
|---|
Safety
| Toxicity | **LD50 values** The estimated dermal LD50 of dutasteride in rabbits is > 2,000 mg/kg. **Overdose** In studies of volunteers receiving single doses of dutasteride up to 40 mg (which is 80 times the therapeutic dose) for 7 days, there were no reports of clinically significant adverse events.Low incidences of impotence, reduced libido, gynecomastia, and ejaculation disorder occurred significantly more often in dutasteride than placebo recipients.There are no known antidotes for dutasteride. In case of overdose, appropriate symptomatic and supportive treatment should be given. **Nonclinical Toxicology** In a 2-year carcinogenicity mouse study, there was an increased incidence of benign hepatocellular adenomas in female mice receiving 250 mg/kg/day.An increased incidence of Leydig cell hyperplasia was observed in male rats receiving doses of 7.5 mg/kg/day and greater. At tumorogenic doses, the luteinizing hormone (LH) levels in rats were increased by 167%. There was no demonstrated a genotoxic potential of dutasteride or its metabolites in a bacterial mutagenesis assay, a chromosomal aberration assay in CHO cells, and a micronucleus assay in rats.At much higher doses than the maximum recommended human dose (MRHD) in sexually mature male rats, dutasteride caused a dose- and time-dependent decrease in fertility, reduced cauda epididymal (absolute) sperm counts but not sperm concentration (at 50 and 500 mg/kg/day), reduced weights of the epididymis, prostate, and seminal vesicles, and microscopic changes in the male reproductive organs.At exposures 425- and 315-fold the expected clinical exposure of dutasteride in rats and dogs, respectively, there were some signs of non-specific, reversible, centrally-mediated toxicity without associated histopathological changes. **Pregnancy and Lactation** As DHT is a necessary hormone for the development of male genitalia, exposure to dutasteride in pregnant women bearing male fetuses may cause fetal harm.In animal reproduction and developmental toxicity studies, dutasteride inhibited normal development of external genitalia in male fetuses.Although it is not known whether dutasteride is excreted in human milk, the use of dutasteride in women of childbearing potential, including nursing women.In elderly patients, the half-life of dutasteride may increase. As the renal elimination of dutasteride is very minimal, the use of dutasteride in patients renal insufficiency is reported to be safe.There are no specific dosage adjustment recommendations for use in elderly patients or patients with renal impairment. |
|---|
High Level Warnings:
- Dermal toxicity is low, with an estimated rabbit dermal LD50 › 2,000 mg/kg
- High-dose volunteer exposure (up to 40 mg/day) showed no clinically significant acute toxic effects
- Nonclinical studies identified dose‑dependent reproductive organ changes in male rats and benign hepatic and Leydig cell findings at high exposures, without evidence of genotoxicity
Dutasteride is a type of 5-alfa-reductase Inhibitors
5-alfa-reductase inhibitors belong to a subcategory of pharmaceutical active ingredients known for their effectiveness in treating conditions related to hormonal imbalances. These inhibitors specifically target and block the activity of the enzyme 5-alfa-reductase, which plays a crucial role in converting testosterone into dihydrotestosterone (DHT) in the body. By inhibiting this enzyme, 5-alfa-reductase inhibitors effectively reduce the levels of DHT, thereby providing therapeutic benefits.
The primary medical application of 5-alfa-reductase inhibitors lies in the treatment of benign prostatic hyperplasia (BPH), a condition characterized by the enlargement of the prostate gland. By inhibiting the conversion of testosterone to DHT, these inhibitors effectively shrink the prostate gland, relieving symptoms such as urinary hesitancy, frequent urination, and weak urine flow.
Furthermore, 5-alfa-reductase inhibitors have demonstrated efficacy in the treatment of male pattern baldness, also known as androgenic alopecia. By reducing the levels of DHT, these inhibitors help slow down hair loss and stimulate hair regrowth in individuals experiencing this condition.
Some commonly prescribed 5-alfa-reductase inhibitors include finasteride and dutasteride. These medications are typically administered orally and are well-tolerated by most individuals. However, it's worth noting that 5-alfa-reductase inhibitors may have potential side effects, including sexual dysfunction and breast tenderness.
In conclusion, 5-alfa-reductase inhibitors are a valuable class of pharmaceutical active ingredients used to treat conditions such as benign prostatic hyperplasia and androgenic alopecia. By blocking the activity of the enzyme 5-alfa-reductase, these inhibitors effectively reduce the levels of dihydrotestosterone, providing therapeutic benefits to patients.
Dutasteride (5-alfa-reductase Inhibitors), 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.
Dutasteride API manufacturers & distributors
Compare qualified Dutasteride API suppliers worldwide. We currently have 15 companies offering Dutasteride API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Aquatic Remedies Pvt Ltd | Producer | India | India | CoA | 35 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Cipla | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 164 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, JDMF, KDMF, MSDS, USDMF, WC | 170 products |
| Glaxosmithkline | Producer | United Kingdom | United Kingdom | CoA, GMP | 19 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hetero Labs | Producer | India | India | CoA, GMP, JDMF, USDMF, WC | 90 products |
| HuNan Kerey | Producer | China | China | CoA | 2 products |
| Hunan Yuxin Pharmaceutica... | Producer | China | China | CoA, USDMF | 14 products |
| Ind-Swift Labs. | Producer | India | India | CoA, FDA, GMP, KDMF, WC | 27 products |
| Metapharmaceutical Indust... | Producer | Spain | China | BSE/TSE, CEP, CoA, GDP, GMP, MSDS, WC, WHO-GMP | 21 products |
| MSN Labs. | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC | 119 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
When sending a request, specify which Dutasteride 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.).
Use the list above to find high-quality Dutasteride API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Dutasteride API
Sourcing
What matters most when sourcing GMP-grade Dutasteride?
Key considerations include confirming that the manufacturer operates under GMP and can meet US and Canadian regulatory expectations. Verification of documentation, such as audit history and regulatory compliance records, is essential. Given the mature post‑patent market, assessing supply chain reliability and consistency across multiple distributors is also important.
Which documents are typically required when sourcing Dutasteride API?
Request the core API documentation set: CoA (14 companies), GMP (11 companies), FDA (8 companies), USDMF (6 companies), WC (6 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Dutasteride API?
Known or reported manufacturers for Dutasteride: Aurora Industry Co., Ltd, Global Pharma Tek, SETV Global, Tenatra Exports Private Limited, Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Dutasteride API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Dutasteride manufacturers?
Audit reports may be requested for Dutasteride: 6 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Dutasteride API on Pharmaoffer?
Reported supplier count for Dutasteride: 14 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Dutasteride API?
Production countries reported for Dutasteride: India (10 producers), China (3 producers), United Kingdom (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Dutasteride usually hold?
Common certifications for Dutasteride suppliers: CoA (14 companies), GMP (11 companies), FDA (8 companies), USDMF (6 companies), WC (6 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Dutasteride (CAS 164656-23-9) used for?
Dutasteride is used to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate. It reduces intraprostatic and circulating dihydrotestosterone by inhibiting type I and II 5α‑reductase, leading to decreased prostate volume and improved urinary flow. It also lowers the risk of acute urinary retention or the need for surgery and may be used alone or with tamsulosin.
Which therapeutic class does Dutasteride fall into?
Dutasteride belongs to the following therapeutic categories: 5-alpha Reductase Inhibitors, Adrenergic alpha-Antagonists, Adrenergic Antagonists, Agents that produce hypertension, Azasteroids. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Dutasteride mainly prescribed for?
The primary indications for Dutasteride: Indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland to improve symptoms, and reduce the risk of acute urinary retention and the need for BPH-related surgery alone or in combination with [tamsulosin]. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Dutasteride work?
The 5α-reductase is a nuclear-bound steroid intracellular enzyme primarily located in the prostatic stromal cell that converts the androgen testosterone into the more active metabolite, 5α-dihydrotestosterone (DHT).DHT is considered to be the primary androgen playing a role in the initial development and subsequent enlargement of the prostate gland. It serves as the hormonal mediator for the hyperplasia upon accumulation within the prostate gland.DHT displays a higher affinity towards androgen receptors in the prostate gland compared to testosteroneand by acting on the androgen receptors, DHT modulates genes that are responsible for cell proliferation.Responsible for the synthesis of approximately one-third of circulating DHT, type I 5α-reductase is predominant in the sebaceous glands of most regions of skin, including the scalp, and liver. The type II 5a-reductase isozyme is primarily found in the prostate, seminal vesicles, epididymides, and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT.Due to its dual inhibition of both isoenzymes of 5α-reductase, Dutasteride causes a near-complete suppression of DHT.Compared to a 70% reduction of serum DHT levels caused by [finasteride], a near-complete suppression of serum DHT-more than 90% is seen with Dutasteride.
By forming a stable complex with both type II and type II 5α-reductase, Dutasteride inhibits its enzymatic action of converting testosterone to 5α-dihydrotestosterone (DHT), which is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. It is proposed that DHT is the principal androgen responsible for prostatic growth in later life-normal masculinization of the external genitalia and maturation of the prostate gland during development-thus reducing the serum DHT levels results in reduced prostatic volume and increased epithelial apoptosis.Dutasteride is a competitive and specific inhibitor of both Type I and Type II 5α-reductase isoenzymes and when evaluated under _in vitro_ and _in vivo_ conditions, the dissociation of the drug from the drug-enzyme complex is reported to be extremely slow.Dutasteride does not bind to the human androgen receptor.
What should someone know about the safety or toxicity profile of Dutasteride?
Dutasteride shows low acute toxicity, with high-dose human exposure and dermal studies indicating minimal short‑term toxic effects. Nonclinical data describe dose‑dependent changes in male reproductive organs and benign hepatic and Leydig cell findings at high exposures, without genotoxicity. Clinical use is associated with sexual adverse effects, possible breast tissue changes, and increased sensitivity in liver impairment due to CYP3A‑dependent metabolism. It is contraindicated in pregnancy because of the potential risk to a developing male fetus.
What are important formulation and handling considerations for Dutasteride as an API?
Dutasteride’s very low aqueous solubility and high lipophilicity favor use of lipid‑based or soft‑gel capsule formulations to support consistent oral absorption. It is chemically stable in solid form but is typically handled under low‑moisture, protected conditions to maintain integrity. The API’s long half‑life and extensive protein binding do not alter basic formulation needs but support dosage forms designed for steady systemic exposure.
Is Dutasteride a small molecule?
Dutasteride is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Dutasteride?
Oral Dutasteride is chemically stable in the solid state, but its very low aqueous solubility favors lipid‑based or soft‑gel formulations that protect the drug from moisture. Because it is hydrophobic, handling typically uses low‑moisture, protected conditions to maintain capsule integrity. No food‑related stability concerns are noted, as oral absorption is not meaningfully affected by fed or fasted state.
Regulatory
Where is Dutasteride approved or in use globally?
Dutasteride is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Dutasteride right now?
Dutasteride is approved in both the United States and Canada for the treatment of benign prostatic hyperplasia. Its original compound and use patents have expired, allowing generic versions to be marketed. Ongoing regulatory oversight in both regions follows standard requirements for established generic APIs.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Dutasteride procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Dutasteride. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Dutasteride included in the PRO Data Insights coverage?
PRO Data Insights coverage for Dutasteride: 1462 verified transactions across 396 suppliers and 254 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Dutasteride?
Market report availability for Dutasteride: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
