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Pimavanserin | CAS No: 706779-91-1 | GMP-certified suppliers
A medication that helps manage hallucinations and delusions in Parkinson’s disease psychosis, supporting reliable sourcing for CNS‑focused treatment portfolios.
Therapeutic categories
AmidesAntidepressive AgentsCentral Nervous System AgentsCentral Nervous System DepressantsCytochrome P-450 CYP2D6 SubstratesCytochrome P-450 CYP3A Substrates
Generic name
Pimavanserin
Molecule type
small molecule
CAS number
706779-91-1
DrugBank ID
DB05316
Approval status
Approved drug, Investigational drug
ATC code
N05AX17
Primary indications
- Pimavanserin is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis
Product Snapshot
- Pimavanserin is an oral small‑molecule API supplied in capsule and coated tablet formulations
- It is used for managing hallucinations and delusions associated with Parkinson’s disease psychosis
- It is FDA approved in the United States, with investigational status in other markets
Clinical Overview
Pimavanserin (CAS 706779-91-1) is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. It is marketed under the brand name Nuplazid and was first approved in the United States in 2016. The compound is a phenol ether belonging to the broader class of serotonergic agents used in central nervous system disorders.
Pimavanserin exerts its therapeutic effect through inverse agonist and antagonist activity at serotonin 5‑HT2A receptors, with high affinity demonstrated by a Ki of 0.087 nM. It also acts at 5‑HT2C receptors with lower affinity and shows minimal binding to sigma 1 receptors. The drug does not exhibit meaningful affinity for dopaminergic, muscarinic, adrenergic, or histaminergic receptors. This receptor selectivity allows treatment of psychotic symptoms in Parkinson’s disease without exacerbating motor dysfunction, which distinguishes it from dopamine‑blocking antipsychotics.
Absorption, distribution, metabolism, and excretion data indicate that pimavanserin is metabolized primarily through CYP3A4 and CYP3A5, with additional contribution from CYP2D6. As a substrate of these pathways, exposure may be altered by strong inhibitors or inducers. Clinical pharmacokinetic and pharmacodynamic analyses show a concentration‑dependent QTc prolongation. At twice the therapeutic dose, the maximum mean change from baseline reached 13.5 msec. In clinical trials at the approved 34 mg dose, mean QTc increases of approximately 5 to 8 msec were observed. Although sporadic QTcF values of 500 msec or greater occurred, rates were similar to placebo and no torsade de pointes events were reported.
Safety considerations include monitoring for QT interval prolongation, assessing drug‑drug interaction potential with CYP3A modulators, and evaluating risk in patients with preexisting cardiac conduction abnormalities.
For API procurement, suppliers should provide robust evidence of impurity control, stereochemical consistency, and stability data suitable for global regulatory submissions, with traceability to GMP‑compliant manufacturing.
Pimavanserin exerts its therapeutic effect through inverse agonist and antagonist activity at serotonin 5‑HT2A receptors, with high affinity demonstrated by a Ki of 0.087 nM. It also acts at 5‑HT2C receptors with lower affinity and shows minimal binding to sigma 1 receptors. The drug does not exhibit meaningful affinity for dopaminergic, muscarinic, adrenergic, or histaminergic receptors. This receptor selectivity allows treatment of psychotic symptoms in Parkinson’s disease without exacerbating motor dysfunction, which distinguishes it from dopamine‑blocking antipsychotics.
Absorption, distribution, metabolism, and excretion data indicate that pimavanserin is metabolized primarily through CYP3A4 and CYP3A5, with additional contribution from CYP2D6. As a substrate of these pathways, exposure may be altered by strong inhibitors or inducers. Clinical pharmacokinetic and pharmacodynamic analyses show a concentration‑dependent QTc prolongation. At twice the therapeutic dose, the maximum mean change from baseline reached 13.5 msec. In clinical trials at the approved 34 mg dose, mean QTc increases of approximately 5 to 8 msec were observed. Although sporadic QTcF values of 500 msec or greater occurred, rates were similar to placebo and no torsade de pointes events were reported.
Safety considerations include monitoring for QT interval prolongation, assessing drug‑drug interaction potential with CYP3A modulators, and evaluating risk in patients with preexisting cardiac conduction abnormalities.
For API procurement, suppliers should provide robust evidence of impurity control, stereochemical consistency, and stability data suitable for global regulatory submissions, with traceability to GMP‑compliant manufacturing.
Identification & chemistry
| Generic name | Pimavanserin |
|---|---|
| Molecule type | Small molecule |
| CAS | 706779-91-1 |
| UNII | JZ963P0DIK |
| DrugBank ID | DB05316 |
Pharmacology
| Summary | Pimavanserin is a selective serotonin receptor modulator that primarily acts as an inverse agonist and antagonist at 5‑HT2A receptors, with lower affinity for 5‑HT2C and minimal activity at other neurotransmitter systems. By targeting serotonergic dysregulation implicated in Parkinson’s disease psychosis, it helps reduce hallucinations and delusions without engaging dopaminergic pathways. Its pharmacodynamic profile is characterized by high 5‑HT2A affinity and concentration‑dependent effects on cardiac repolarization. |
|---|---|
| Mechanism of action | Parkinson's disease psychosis (PDP) is an imbalance of serotonin and dopamine from disruption of the normal balance between the serotonergic and dopaminergic receptors and neurotransmitters in the brain. The mechanism by which pimavanserin treats hallucinations and delusions associated with Parkinson’s disease psychosis is not fully established. It is possible that pimavanserin acts via inverse agonist and antagonist activity at serotonin 5-HT<sub>2A</sub> receptors with limited effects on serotonin 5-HT<sub>2C</sub> receptors. Pimavanserin is an inverse agonist and antagonist of serotonin 5-HT<sub>2A</sub> receptors with high binding affinity, demonstrating low binding affinity to serotonin 5-HT<sub>2C</sub> receptors. In addition, this drug exhibits low affinity binding to sigma 1 receptors.Pimavanserin lacks activity at muscarinic, dopaminergic, adrenergic, and histaminergic receptors, preventing various undesirable effects typically associated with antipsychotics. |
| Pharmacodynamics | Pimavanserin's unique actions on serotonin receptors improve symptoms of hallucinations and delusions associated with Parkinson's disease.In clinical studies, 80.5% of individuals treated with pimavanserin reported improvement in symptoms. Pimavanserin does not worsen motor functioning in patients with Parkinson's disease psychosis. In vitro, pimavanserin acts as an inverse agonist and antagonist at serotonin 5-HT<sub>2A</sub> receptors with high binding affinity (K<sub>i</sub> value 0.087 nM) and at serotonin 5-HT<sub>2C</sub> receptors with lower binding affinity (K<sub>i</sub> value 0.44 nM). Pimavanserin shows low binding to sigma 1 receptors (K<sub>i</sub> value 120 nM) and has no appreciable affinity (K<sub>i</sub> value >300 nM), to serotonin 5-HT<sub>2B</sub>, dopaminergic (including D<sub>2</sub>), muscarinic, histaminergic, or adrenergic receptors, or to calcium channels. The effect of pimavanserin on the QTc interval was evaluated in a randomized placebo- and positive-controlled double-blind, multiple-dose parallel thorough QTc study in 252 healthy subjects. A central tendency analysis of the QTc data at steady-state demonstrated that the maximum mean change from baseline (upper bound of the two-sided 90% CI) was 13.5 (16.6) msec at a dose of twice the therapeutic dose. A pharmacokinetic/pharmacodynamic analysis with pimavanserin suggested a concentration-dependent QTc interval prolongation in the therapeutic range. In the 6-week, placebo-controlled effectiveness studies, mean increases in QTc interval of ~5-8 msec were observed in patients receiving once-daily doses of pimavanserin 34 mg. These data are consistent with the profile observed in a thorough QT study in healthy subjects. Sporadic QTcF values ≥500 msec and change from baseline values ≥60 msec were observed in subjects treated with pimavanserin 34 mg; although the incidence was generally similar for pimavanserin and placebo groups. There were no reports of torsade de pointes or any differences from placebo in the incidence of other adverse reactions associated with delayed ventricular repolarization in studies of pimavanserin, including those patients with hallucinations and delusions associated with Parkinson’s disease psychosis. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 5-hydroxytryptamine receptor 2A | Humans | inverse agonist |
| 5-hydroxytryptamine receptor 2C | Humans | inverse agonist |
| Sigma non-opioid intracellular receptor 1 | Humans | binder |
ADME / PK
| Absorption | The median T<sub>max</sub> of pimavanserin in clinical studies was 6 hours, regardless of the dose. The bioavailability of an oral tablet of pimavanserin and a solution were almost identical.Ingestion of a high-fat meal had no significant effect on the rate (C<sub>max</sub>) and extent (AUC) of pimavanserin exposure. C<sub>max</sub> decreased by about 9% while AUC increased by about 8% with a high-fat meal. The major active circulating N-desmethylated metabolite, AC-279, has a median T<sub>max</sub> of 6 hours. |
|---|---|
| Half-life | The average plasma half-lives for pimavanserin and its active metabolite (AC-279) are estimated at 57 hours and 200 hours, respectively. |
| Protein binding | Pimavanserin is highly protein-bound (~95%) in human plasma. Protein binding appeared to be dose-independent and did not change significantly over dosing time from Day 1 to Day 14. |
| Metabolism | Pimavanserin is mainly metabolized CYP3A4 and CYP3A5 hepatic cytochrome enzymes, and to a lesser extent by CYP2J2, CYP2D6, and other cytochrome and flavin-containing monooxygenase enzymes. CYP3A4 metabolizes pimavanserin to its major active metabolite, AC-279. |
| Route of elimination | Approximately 0.55% of the 34 mg oral dose of <sup>14</sup>C-pimavanserin was eliminated as unchanged drug in urine and 1.53% was eliminated in feces after 10 days. Less than 1% of the administered dose of pimavanserin and its active metabolite AC-279 were recovered in urine. |
| Volume of distribution | Following administration of a single dose of 34 mg, the average apparent volume of distribution was 2173 L in clinical studies. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity support use in solid oral dosage forms with solubility‑enhancing excipients if rapid dissolution is required.
- Solid small‑molecule API suitable for standard oral manufacturing; avoid grapefruit and strong CYP3A4 modulators when considering patient-use labeling but not a formulation constraint.
- Chemically stable phenol‑ether structure; typical protection from light and moisture is adequate during handling and storage.
Regulatory status
| Lifecycle | Most U.S. patents for the API have already expired, with remaining protections extending into 2025–2028, indicating a transition from early generic exposure toward full loss of exclusivity later in the decade. With commercialization limited to the U.S. market, its lifecycle is entering a mature phase as remaining patent barriers approach expiry. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Pimavanserin is supplied by a single originator company, with branded product availability limited to the US market. No established global (EU or other region) branded presence is evident. While some U.S. patents have expired, remaining protections extending through 2025–2028 indicate that broad generic competition is likely constrained until those later expiries. |
|---|
Safety
| Toxicity | LD50 information for pimavanserin is not readily available in the literature. Pre-marketing clinical trials involving pimavanserin in approximately 1200 subjects and patients do not report symptoms of overdose. In healthy subject studies, nausea and vomiting were reported. There are no known antidotes for an overdose with this drug. Cardiovascular monitoring should begin immediately in the case of an overdose and continuous ECG monitoring is recommended. If antiarrhythmic drugs are administered in an overdose of pimavanserin, disopyramide, procainamide, and quinidine should not be used due to their potential for QT-prolonging effects. In the case of an overdose, consider the 57 hour plasma half-life of pimavanserin and the possibility of multiple drug involvement. |
|---|
High Level Warnings:
- No established LD50
- Clinical data indicate nausea and vomiting as primary acute effects, with no specific antidote identified
- Prolonged plasma half‑life (~57 hours) may extend systemic exposure and complicate clearance in high‑dose situations
Pimavanserin is a type of Atypical antipsychotics
Atypical antipsychotics belong to the subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various mental disorders, particularly schizophrenia and bipolar disorder. These medications are designed to alleviate the symptoms of psychosis by targeting specific neuroreceptors in the brain.
Unlike traditional antipsychotics, atypical antipsychotics exhibit a different pharmacological profile, providing a more favorable side effect profile and improved efficacy. These medications primarily act on dopamine and serotonin receptors, regulating the neurotransmitter levels in the brain to restore the chemical balance.
The mechanism of action of atypical antipsychotics involves blocking dopamine receptors, particularly D2 receptors, as well as modulating serotonin receptors, notably 5-HT2A receptors. By inhibiting excessive dopamine transmission and enhancing serotonin activity, atypical antipsychotics help reduce hallucinations, delusions, and other psychotic symptoms.
Some commonly used atypical antipsychotics include risperidone, olanzapine, quetiapine, and aripiprazole. These APIs are typically formulated into oral tablets or capsules for convenient administration.
Despite their effectiveness, atypical antipsychotics may have potential side effects such as weight gain, metabolic abnormalities, sedation, and extrapyramidal symptoms. Therefore, close monitoring and individualized treatment plans are essential to ensure optimal therapeutic outcomes.
In conclusion, atypical antipsychotics are a crucial subcategory of APIs used in the treatment of mental disorders. Their distinct pharmacological profile and mechanism of action make them valuable in managing psychosis while minimizing adverse effects.
Pimavanserin (Atypical antipsychotics), classified under Antipsychotics
Antipsychotics belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category used to treat psychiatric disorders such as schizophrenia, bipolar disorder, and other related conditions. These medications play a crucial role in managing symptoms associated with psychosis, including hallucinations, delusions, and disorganized thinking.
Antipsychotics work by modulating the levels of neurotransmitters in the brain, particularly dopamine and serotonin. They can be categorized into two classes: first-generation (typical) antipsychotics and second-generation (atypical) antipsychotics. Typical antipsychotics primarily target dopamine receptors, while atypical antipsychotics also affect serotonin receptors.
The pharmaceutical API category of antipsychotics includes various well-known drugs, such as haloperidol, chlorpromazine, risperidone, quetiapine, and olanzapine. These APIs are often formulated into different dosage forms, including tablets, capsules, injections, and oral suspensions, to provide flexibility in administration and patient-specific needs.
Antipsychotics offer relief from psychotic symptoms by stabilizing the imbalanced neurotransmitter activity in the brain. However, they may also have certain side effects, such as sedation, weight gain, extrapyramidal symptoms, and metabolic disturbances. It is essential for healthcare professionals to carefully monitor patients receiving antipsychotic treatment to optimize therapeutic benefits while minimizing adverse effects.
In summary, antipsychotics are a vital category of pharmaceutical APIs used to manage psychiatric disorders by modulating neurotransmitter activity in the brain. Their effectiveness in treating psychosis has made them a cornerstone of mental health treatment, providing much-needed relief to individuals suffering from these conditions.
Pimavanserin API manufacturers & distributors
Compare qualified Pimavanserin API suppliers worldwide. We currently have 5 companies offering Pimavanserin 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CEP, CoA, GMP, USDMF | 229 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| MSN Life Sciences | Producer | India | India | CoA, USDMF | 46 products |
| Polpharma | Producer | Poland | Poland | BSE/TSE, CoA, FDA, GMP, MSDS, USDMF | 64 products |
When sending a request, specify which Pimavanserin 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 Pimavanserin 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 Pimavanserin API
Sourcing
What matters most when sourcing GMP-grade Pimavanserin?
When sourcing GMP‑grade Pimavanserin, the key considerations are U.S. regulatory compliance and verification that the material is produced under full GMP controls. Because supply is limited to a single originator in the U.S., confirming legitimate sourcing and chain‑of‑custody is essential. Remaining U.S. patent protections through 2025–2028 also mean that alternative GMP sources are unlikely to be broadly available until those expiries.
Which documents are typically required when sourcing Pimavanserin API?
Request the core API documentation set: CoA (5 companies), USDMF (4 companies), BSE/TSE (4 companies), GMP (4 companies), MSDS (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Pimavanserin API?
Known or reported manufacturers for Pimavanserin: Polpharma, Apino Pharma Co., Ltd., Global Pharma Tek, LGM Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Pimavanserin 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 Pimavanserin manufacturers?
Audit reports may be requested for Pimavanserin: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Pimavanserin API on Pharmaoffer?
Reported supplier count for Pimavanserin: 5 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Pimavanserin API?
Production countries reported for Pimavanserin: India (2 producers), Poland (1 producer), China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Pimavanserin usually hold?
Common certifications for Pimavanserin suppliers: CoA (5 companies), USDMF (4 companies), BSE/TSE (4 companies), GMP (4 companies), MSDS (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Pimavanserin (CAS 706779-91-1) used for?
Pimavanserin is used to treat hallucinations and delusions associated with Parkinson’s disease psychosis. It works as a selective serotonin 5‑HT2A inverse agonist and antagonist, providing antipsychotic effects without meaningful activity at dopaminergic receptors.
Which therapeutic class does Pimavanserin fall into?
Pimavanserin belongs to the following therapeutic categories: Amides, Antidepressive Agents, Central Nervous System Agents, Central Nervous System Depressants, Cytochrome P-450 CYP2D6 Substrates. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Pimavanserin mainly prescribed for?
The primary indications for Pimavanserin: Pimavanserin is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Pimavanserin work?
Parkinson's disease psychosis (PDP) is an imbalance of serotonin and dopamine from disruption of the normal balance between the serotonergic and dopaminergic receptors and neurotransmitters in the brain.
The mechanism by which Pimavanserin treats hallucinations and delusions associated with Parkinson’s disease psychosis is not fully established. It is possible that Pimavanserin acts via inverse agonist and antagonist activity at serotonin 5-HT2A receptors with limited effects on serotonin 5-HT2C receptors. Pimavanserin is an inverse agonist and antagonist of serotonin 5-HT2A receptors with high binding affinity, demonstrating low binding affinity to serotonin 5-HT2C receptors. In addition, this drug exhibits low affinity binding to sigma 1 receptors.Pimavanserin lacks activity at muscarinic, dopaminergic, adrenergic, and histaminergic receptors, preventing various undesirable effects typically associated with antipsychotics.
What should someone know about the safety or toxicity profile of Pimavanserin?
Pimavanserin’s acute toxicity profile is characterized mainly by nausea and vomiting, with no established LD50 and no specific antidote. Its long plasma half‑life of about 57 hours can prolong systemic exposure in overdose situations. The drug produces concentration‑dependent QTc prolongation, so patients with cardiac conduction issues or those taking CYP3A inhibitors or inducers should be monitored. Sporadic QTcF values of 500 msec or greater have been seen, but torsade de pointes has not been reported in clinical studies.
What are important formulation and handling considerations for Pimavanserin as an API?
Pimavanserin’s low aqueous solubility supports use of solubility‑enhancing excipients if faster dissolution is needed in oral solid forms. The API is chemically stable but should be protected from light and moisture during handling and storage. Its high protein binding and long half‑life do not impose specific formulation constraints but reinforce the suitability of conventional oral dosage manufacturing. Avoidance of grapefruit or strong CYP3A4 modulators is a patient‑use consideration rather than a formulation requirement.
Is Pimavanserin a small molecule?
Pimavanserin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Pimavanserin?
Pimavanserin is chemically stable as a solid oral API and generally requires only standard protection from light and moisture during manufacturing and storage. Its low aqueous solubility may warrant use of solubility‑enhancing excipients if rapid dissolution is needed, but this is a formulation consideration rather than a stability risk. No additional stability concerns are indicated beyond routine handling for solid oral dosage forms.
Regulatory
Where is Pimavanserin approved or in use globally?
Pimavanserin is reported as approved in the following major regions: US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Pimavanserin right now?
In the United States, Pimavanserin is subject to FDA regulation as an approved active pharmaceutical ingredient. Patent protection and exclusivity for the compound follow the standard U.S. framework, which is determined by issued patents and regulatory exclusivities listed in public patent and FDA records.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Pimavanserin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Pimavanserin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Pimavanserin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Pimavanserin: 75 verified transactions across 40 suppliers and 24 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Pimavanserin?
Market report availability for Pimavanserin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
