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Tazarotene | CAS No: 118292-40-3 | GMP-certified suppliers
A medication that helps manage psoriasis, acne, and sun‑damaged skin, supporting consistent therapeutic outcomes for dermatology‑focused pharmaceutical sourcing needs.
Therapeutic categories
Primary indications
- Used to treat psoriasis, acne and sun damaged skin (photodamage)
Product Snapshot
- Tazarotene is supplied primarily as a topical dermatologic formulation in creams, gels, foams, and lotions, with oral forms remaining investigational
- It is used for psoriasis, acne, and photodamage applications
- It holds approved status in the US and Canada for topical use, with oral development classified as investigational
Clinical Overview
The therapeutic activity of tazarotene is mediated by tazarotenic acid, which interacts with retinoic acid receptors RARα, RARβ, and RARγ, with relative selectivity for RARβ and RARγ. These interactions influence gene transcription related to keratinocyte differentiation and proliferation, supporting its use in hyperproliferative and dysregulated epidermal conditions. Binding affinity for RXR receptors has also been reported, though the functional relevance is not fully established.
After topical administration, systemic exposure is generally low. Absorbed drug is rapidly converted to tazarotenic acid, followed by oxidative metabolism, including CYP2C8-mediated pathways. Elimination occurs predominantly through renal and fecal routes as metabolites. Data indicate limited bioaccumulation with routine dermatologic dosing.
Safety considerations focus on local irritation, erythema, desquamation, and photosensitivity. As a retinoid, tazarotene carries teratogenic risk, making pregnancy contraindication and effective contraception essential. Long-term dermatologic studies have reported reductions in atypical epidermal cells and structural improvements in collagen organization; however, such findings should be interpreted within the context of study design and clinical relevance. Co-administration with oral antibiotics may occur in acne management to address complementary pathogenic pathways.
For API procurement, suppliers should provide evidence of retinoid-specific stability controls, impurity profiling consistent with regulatory expectations, and light- and oxygen-protective handling measures. Verification of stereochemical integrity and validated analytical methods is critical for ensuring consistent quality of this photosensitive prodrug.
Identification & chemistry
| Generic name | Tazarotene |
|---|---|
| Molecule type | Small molecule |
| CAS | 118292-40-3 |
| UNII | 81BDR9Y8PS |
| DrugBank ID | DB00799 |
Pharmacology
| Summary | Tazarotene is a topical retinoid that is hydrolyzed to tazarotenic acid, which binds RAR‑α, RAR‑β, RAR‑γ and also exhibits affinity for RXR receptors. Through modulation of retinoid‑responsive gene expression, it influences keratinocyte differentiation and epidermal remodeling relevant to psoriasis, acne, and photodamaged skin. Its pharmacodynamic effects reflect retinoid‑mediated changes in cellular turnover and dermal matrix organization. |
|---|---|
| Mechanism of action | Although the exact mechanism of tazarotene action is not known, studies have shown that the active form of the drug (tazarotenic acid) binds to all three members of the retinoic acid receptor (RAR) family: RARa, RARb, and RARg, but shows relative selectivity for RARb, and RARg and may modify gene expression. It also has affinity for RXR receptors. |
| Pharmacodynamics | Following topical application, tazarotene undergoes esterase hydrolysis to form its active metabolite, tazarotenic acid. When treating acne tazarotene may be taken in conjunction with an oral antibiotic. Tazarotene has been shown in peer-reviewed double blinded studies to reduce: mottling and hyperpigmentation, sallowness, fine wrinkling and coarse wrinkling in sun damaged skin. Histological studies have shown that long term (greater than 1 year) use of Tazarotene is associated with a significant reduction in atypical melanocytes and keratocytes - cells considered to be precursors of skin cancer. Some studies have shown long term use of Tazarotene to be associated with increased collagen production and better organization of skin collagen bundles. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Retinoic acid receptor alpha | Humans | agonist |
| Retinoic acid receptor RXR-beta | Humans | agonist |
| Retinoic acid receptor gamma | Humans | agonist |
ADME / PK
| Absorption | Minimal systemic absorption of tazarotene occurs due to its rapid metabolism in the skin to the active metabolite, tazarotenic acid, which can be systemically absorbed and further metabolized. Gender had no influence on the systemic bioavailability of tazarotenic acid. |
|---|---|
| Half-life | The half-life of the active form of the drug, tazarotenic acid, is approximately 18 hours in normal and psoriatic patients. |
| Protein binding | The active form of the drug, tazarotenic acid, is highly bound to plasma proteins (>99%). |
| Metabolism | Undergoes esterase hydrolysis in skin to form its active metabolite, tazarotenic acid. Tazarotenic acid is further metabolized in skin and, after systemic absorption, hepatically metabolized to sulfoxides, sulfones, and other polar products for elimination. |
| Route of elimination | Tazarotene and tazarotenic acid were metabolized to sulfoxides, sulfones and other polar metabolites which were eliminated through urinary and fecal pathways. |
Formulation & handling
- Topical retinoid with very low aqueous solubility, typically requiring lipid‑based or solvent‑enhanced vehicles for effective cutaneous delivery.
- Light- and oxidation‑sensitive small molecule; formulations often need antioxidants and protection from photodegradation during handling and storage.
- High lipophilicity (LogP ~5) supports dermal penetration but limits suitability for aqueous systems, favoring creams, gels, and lotions over aqueous solutions.
Regulatory status
| Lifecycle | Most foundational patents for the API have expired in the US and Canada, indicating a mature market, while later‑expiring US patents extending into 2030–2031 suggest remaining periods of protection for certain aspects of the product. Overall, the API is in a late lifecycle stage with limited but ongoing exclusivity in the United States. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Tazarotene is supplied primarily by a single originator manufacturer, with affiliated entities handling packaging for distribution. Branded products are established in the US and Canada, with no evidence of broader global market presence. Several key patents have expired, but remaining protections extending to 2030–2031 indicate that full generic competition may be limited until those later expiries. |
|---|
Safety
| Toxicity | Excessive topical use may lead to marked redness, peeling, or discomfort. Oral ingestion of the drug may affect liver function causing hypertriglyceridemia. Other symptoms may include conjunctival irritation, hair loss, headache, edema, fatigue, dermatitis, nausea, and visual disturbances. Oral administration of this material to rats and rabbits at doses of 0.20 mg/kg/day (rabbits) and 0.25 mg/kg/day (rats) resulted in developmental toxicity. A no effect level of 0.05 mg/kg/day was established. Similar teratogenic effects have been reported for other retinoid compounds. |
|---|
- Excessive dermal exposure is associated with pronounced erythema, desquamation, and irritation
- Inhalation or incidental oral exposure may trigger systemic effects including liver function alterations and hypertriglyceridemia
- Reported systemic adverse findings include conjunctival irritation, alopecia, headache, edema, fatigue, dermatitis, nausea, and visual disturbances
Tazarotene is a type of Retinoids
Retinoids are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in dermatology and skincare products. Derived from vitamin A, retinoids play a crucial role in promoting skin health and treating various skin conditions. They are popular due to their proven effectiveness in combating acne, reducing wrinkles, and improving overall skin texture.
Retinoids work by binding to specific receptors in the skin cells, influencing gene expression and cellular processes. This action helps regulate the growth and differentiation of skin cells, promoting the turnover of old cells and the production of new, healthier cells. As a result, retinoids can unclog pores, reduce sebum production, and prevent the formation of acne lesions.
Furthermore, retinoids stimulate collagen production, which enhances skin elasticity and reduces the appearance of fine lines and wrinkles. They also possess antioxidant properties, protecting the skin from damage caused by environmental factors such as UV radiation.
Common retinoids used in skincare formulations include retinol, retinaldehyde, and tretinoin (also known as all-trans retinoic acid). These compounds vary in their potency and stability, with tretinoin being the most potent and retinol requiring conversion within the skin to become active.
However, it is important to note that retinoids may cause skin irritation, redness, and dryness, especially during the initial stages of usage. Gradual introduction and proper skincare routines can help minimize these side effects.
In summary, retinoids are a highly sought-after subcategory of pharmaceutical APIs for their significant benefits in skincare. They offer a promising solution for those seeking to improve their skin's health, combat acne, and reduce signs of aging.
Tazarotene (Retinoids), classified under Dermatological Agents
Dermatological agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the formulation of various skincare and dermatology products. These APIs are specifically designed to target and treat skin conditions, offering effective solutions for a wide range of dermatological concerns.
Dermatological agents encompass a diverse array of compounds, including corticosteroids, antifungal agents, antibacterials, retinoids, and immunomodulators. Each API within this category possesses unique properties and mechanisms of action, enabling them to address specific skin-related issues.
Corticosteroids, for instance, are potent anti-inflammatory agents commonly used in the treatment of skin conditions like eczema, psoriasis, and dermatitis. Antifungal agents, on the other hand, combat fungal infections such as athlete's foot or ringworm. Antibacterials are effective against bacterial infections, while retinoids promote skin cell turnover and treat acne and photoaging. Immunomodulators regulate the immune response, providing relief from conditions like atopic dermatitis.
The development and application of dermatological APIs involve rigorous research, clinical trials, and regulatory compliance. These APIs are typically integrated into topical creams, ointments, gels, and lotions, ensuring targeted delivery to the affected areas of the skin.
Dermatological agents play a crucial role in the management and treatment of various skin disorders. By harnessing the therapeutic properties of these APIs, pharmaceutical companies can develop innovative skincare products that cater to the diverse needs of individuals seeking effective dermatological solutions.
Tazarotene API manufacturers & distributors
Compare qualified Tazarotene API suppliers worldwide. We currently have 3 companies offering Tazarotene 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 |
|---|---|---|---|---|---|
| PCAS | Producer | France | Unknown | CoA, USDMF | 29 products |
| Piramal Healthcare | Producer | United Kingdom | India | CoA, USDMF | 31 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001 | 757 products |
When sending a request, specify which Tazarotene 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 Tazarotene 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 Tazarotene API
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Technical
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Regulatory
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Pharmaoffer
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