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Flibanserin | CAS No: 167933-07-5 | GMP-certified suppliers
A medication that treats hypoactive sexual desire disorder in premenopausal women by modulating central nervous system pathways involved in sexual desire and neurotransmitter balance.
Therapeutic categories
Primary indications
- For the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women
Product Snapshot
- Flibanserin is formulated as an oral film-coated tablet
- It is primarily indicated for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women
- The product is approved for commercial use in the US and Canada, with investigational status in additional markets
Clinical Overview
Pharmacologically, flibanserin is classified as a phenylpiperazine derivative. Its mechanism of action centers on modulation of central serotonin receptors, specifically high-affinity agonism at 5-HT1A receptors and antagonism at 5-HT2A receptors. These interactions contribute to a net reduction in central serotonin levels, while concomitantly increasing dopaminergic and noradrenergic neurotransmission. The drug also exhibits moderate antagonist activity at dopamine D4 and serotonin 5-HT2B and 5-HT2C receptors. This profile is believed to influence neural circuits involved in reward processing, which may underlie its therapeutic effects on sexual desire.
Absorption, distribution, metabolism, and excretion (ADME) data indicate that flibanserin is metabolized primarily through hepatic cytochrome P450 enzymes, notably CYP3A4 isoforms. It is both a substrate for CYP3A4 and exhibits inhibitory effects on P-glycoprotein transporters, highlighting significant potential for drug-drug interactions. Flibanserin’s pharmacokinetic profile necessitates careful consideration of concomitant medications, particularly those affecting serotonin levels, due to an increased risk of serotonin syndrome. Safety assessments have identified adverse effects including hypotension, syncope, and central nervous system depression, underscoring the importance of monitoring blood pressure and patient responsiveness.
Flibanserin is marketed under various brand names, with its primary indication restricted to premenopausal women exhibiting acquired, generalized HSDD. Its use remains limited to clinical settings with appropriate risk management strategies.
From an API sourcing perspective, flibanserin production demands rigorous quality control to ensure purity, potency, and compliance with regulatory standards for opioids and central nervous system agents. Given its susceptibility to metabolic interactions, batch-to-batch consistency in impurity profiles and stability should be tightly controlled. Manufacturers must adhere to good manufacturing practices (GMP) and provide comprehensive characterization data to support regulatory submissions and global supply chain integrity.
Identification & chemistry
| Generic name | Flibanserin |
|---|---|
| Molecule type | Small molecule |
| CAS | 167933-07-5 |
| UNII | 37JK4STR6Z |
| DrugBank ID | DB04908 |
Pharmacology
| Summary | Flibanserin modulates central neurotransmitter systems by acting as a 5-HT1A receptor agonist and 5-HT2A receptor antagonist, with additional moderate antagonism at dopamine D4 and other serotonin receptors. This receptor activity influences serotonin, dopamine, and norepinephrine levels, which are implicated in reward processing pathways. The compound is indicated for managing hypoactive sexual desire disorder in premenopausal women. |
|---|---|
| Mechanism of action | Flibansetrin has high affinity for serotonin receptors in the brain: it acts as an agonist on 5-HT1A and an antagonist on 5-HT2A. In vivo, flibanserin binds equally to 5-HT1A and 5-HT2A receptors. However, under higher levels of brain 5-HT (i.e., under stress), flibanserin may occupy 5-HT2A receptors in higher proportion than 5-HT(1A) receptors. It may also moderately antagonize D4 (dopamine) receptors and 5-HT2B and 5-HTB2C. Its action on neurotransmitter receptors may contribute to reduction in serotonin levels and increase in dopamine and norepinephrine levels, all of which may play part in reward processing. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 5-hydroxytryptamine receptor 1A | Humans | agonist |
| 5-hydroxytryptamine receptor 2A | Humans | antagonist |
| Dopamine D4 receptor | Humans | antagonist, agonist |
ADME / PK
| Absorption | Flibanserin has an absolute oral availability of 33%. |
|---|---|
| Half-life | ≈11 hours |
| Protein binding | ~98%, highly bound to proteins (mostly albumin) in serum. |
| Metabolism | Metabolism is primarily via CYP3A4, slightly CYP2C19. Minimal involvement of CYP1A2, CYP2B6, CYP2C8, CYP2C9 or CYP2D6. At least 35 metabolites of flibanserin are produced, 2 of which reach plasma concentrations as high as parent drug, however they are pharmacologically inactive. |
| Route of elimination | Elimination via feces (51%) and urine (44%) following a single oral 50 mg dose of flibanserin solution. |
Formulation & handling
- Flibanserin is a small molecule phenylpiperazine intended for oral administration as film-coated tablets.
- The drug exhibits moderate lipophilicity (LogP 3.83) and low water solubility, which may influence formulation strategies.
- Avoid co-administration with alcohol, grapefruit products, and St. John's Wort due to potential interactions affecting CNS and metabolism.
Regulatory status
| Lifecycle | The API's key US patents expired between August 2022 and May 2023, indicating the product is transitioning into a mature market phase with potential for generic competition in the US and Canada. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Flibanserin is primarily marketed in North America, specifically in the US and Canada, with branded products available under the name Addyi. Multiple patents for flibanserin have recently expired or are set to expire, indicating the potential for existing or upcoming generic competition within the US market. The supply landscape likely involves a limited number of originator companies with a focus on these geographic regions. |
|---|
Flibanserin is a type of Psychopharmaceuticals
Psychopharmaceuticals are a crucial subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are designed to treat mental health disorders. These medications play a vital role in managing various psychiatric conditions, including depression, anxiety, schizophrenia, bipolar disorder, and attention-deficit/hyperactivity disorder (ADHD).
Psychopharmaceutical APIs act on the central nervous system (CNS) to alter brain chemistry and neurotransmitter activity. They can modulate the levels of neurotransmitters such as serotonin, dopamine, and norepinephrine, which are involved in regulating mood, cognition, and emotions. By targeting these neurotransmitter systems, psychopharmaceuticals help restore the balance of chemicals in the brain, alleviating symptoms and improving overall mental well-being.
These APIs are developed through rigorous research and development processes, involving extensive clinical trials to ensure their safety and efficacy. Manufacturers adhere to stringent quality standards and regulations to produce psychopharmaceutical APIs that meet the highest pharmaceutical industry standards.
The production of psychopharmaceutical APIs requires advanced technologies and specialized equipment to achieve precise control over the manufacturing process. This ensures the consistency and purity of the APIs, which is crucial for producing reliable and effective psychopharmaceutical formulations.
The market for psychopharmaceuticals is growing rapidly due to increasing awareness and recognition of mental health disorders. With the rising demand, pharmaceutical companies are continuously investing in research and development to discover novel psychopharmaceutical APIs and improve existing formulations.
In conclusion, psychopharmaceutical APIs form a vital subcategory of pharmaceutical ingredients used to treat mental health disorders. These medications act on the central nervous system to modulate neurotransmitter activity and restore the balance of brain chemistry. The development and manufacturing of psychopharmaceutical APIs require advanced technologies and adherence to stringent quality standards. With the growing demand for mental health treatments, the psychopharmaceutical market continues to evolve, offering new therapeutic options for patients in need.
Flibanserin (Psychopharmaceuticals), classified under Central Nervous System Agents
Central Nervous System (CNS) Agents are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that specifically target the central nervous system. The CNS encompasses the brain and spinal cord, playing a vital role in regulating and controlling various bodily functions, including cognition, movement, emotions, and sensory perception. These agents are designed to interact with specific receptors, enzymes, or ion channels within the CNS to modulate neural activity and restore normal functioning.
CNS agents comprise a diverse range of pharmaceutical APIs, including analgesics, anesthetics, antipsychotics, sedatives, hypnotics, anti-epileptics, and antidepressants. Each subcategory addresses distinct neurological disorders and conditions. For instance, analgesics alleviate pain by targeting receptors in the brain and spinal cord, while antipsychotics are employed to manage psychosis symptoms in mental illnesses such as schizophrenia.
The development of CNS agents involves rigorous research, molecular modeling, and extensive clinical trials to ensure safety, efficacy, and specific target engagement. Pharmaceutical companies invest significant resources in identifying novel drug targets, synthesizing new compounds, and optimizing their pharmacological properties. These agents undergo rigorous regulatory evaluations and must adhere to stringent quality standards and guidelines.
Given the prevalence of CNS disorders globally, the market demand for effective CNS agents is substantial. The development of innovative CNS APIs not only improves patient outcomes but also provides valuable commercial opportunities for pharmaceutical companies. Continued advancements in CNS agent research and development hold the promise of groundbreaking therapies that can improve the quality of life for individuals affected by neurological conditions.
Flibanserin API manufacturers & distributors
Compare qualified Flibanserin API suppliers worldwide. We currently have 4 companies offering Flibanserin API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| AMARI TRADE ALLIANEC LLP | Distributor | India | India | CoA | 15 products |
| Bidachem | Producer | Italy | Italy | CoA, GMP | 14 products |
| ChemExpress | Producer | United States | China | CoA, GMP, ISO9001, MSDS, USDMF, WC | 197 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
When sending a request, specify which Flibanserin 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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