Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Atogepant API Manufacturers & Suppliers
3 verified results
Commercial-scale Suppliers
Employees: 50+
All certificates
Employees: 10+
All certificates
Employees: 21,650
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Atogepant | CAS No: 1374248-81-3 | GMP-certified suppliers
A medication that enables preventive management of migraine in adults across key markets, supporting dependable global API sourcing and formulation requirements.
Therapeutic categories
Primary indications
- Atogepant is indicated for the preventive treatment of migraine in adults by the FDA, EMA, and Health Canada
Product Snapshot
- Atogepant is an oral small‑molecule API supplied in tablet form
- It is used for the preventive management of migraine in adult populations
- It holds regulatory approvals in the US, EU, and Canada, with approved status for migraine prevention and some investigational development in other regions
Clinical Overview
Its clinical utility is based on blocking the activity of CGRP, a pronociceptive neuropeptide implicated in migraine pathophysiology. CGRP is released from trigeminal sensory neurons and contributes to vasodilation, neuronal sensitization, and amplification of pain signaling within the trigeminovascular system. Migraine attacks are associated with elevated circulating CGRP concentrations, and normalization of these levels correlates with symptom improvement. By competing with endogenous CGRP at its receptor, atogepant reduces downstream signaling that sustains headache pain. Unlike some other oral CGRP receptor antagonists, atogepant is intended for continuous daily administration to reduce migraine frequency rather than for acute relief.
Atogepant demonstrates dose‑dependent pharmacodynamic effects consistent with CGRP receptor blockade. No adjustment is required in mild or moderate hepatic or renal impairment, but the drug should be avoided in severe hepatic impairment and limited to a maximum daily dose of 10 mg in severe renal impairment.
Key disposition characteristics include metabolism primarily via CYP3A4, with the molecule also interacting with transporter systems such as P‑glycoprotein, BCRP, and OATP family transporters. These properties support attention to potential drug interactions with strong CYP3A4 modulators or transporter inhibitors.
Safety data indicate a generally favorable profile in clinical use, with adverse events typically mild to moderate. Use in populations with significant hepatic or renal dysfunction requires caution due to altered exposure.
For API sourcing, manufacturers should verify compliance with regional regulatory expectations, control polymorphic form and impurity profiles, and ensure that synthesis routes support consistent quality suitable for global formulation and clinical supply needs.
Identification & chemistry
| Generic name | Atogepant |
|---|---|
| Molecule type | Small molecule |
| CAS | 1374248-81-3 |
| UNII | 7CRV8RR151 |
| DrugBank ID | DB16098 |
Pharmacology
| Summary | Atogepant is a small‑molecule antagonist of the calcitonin gene–related peptide (CGRP) receptor, a key mediator of trigeminal nerve–driven vasodilation and nociceptive signaling in migraine. By blocking CGRP receptor activation, it reduces downstream neuronal excitability and the propagation of migraine‑associated pain pathways. Its pharmacologic intent is preventive modulation of CGRP‑dependent mechanisms implicated in migraine initiation and maintenance. |
|---|---|
| Mechanism of action | The currently accepted theory of migraine pathophysiology considers dysfunction of the central nervous system, in particular the trigeminal ganglion, to be the root cause behind the condition.Activation of the trigeminal ganglion triggers the stimulation of trigeminal afferents that project to the spinal cord and synapse on various pain-sensing intra- and extracranial structures, such as the dura mater. Pain signals are then further transmitted via second-order ascending neurons to the brainstem, hypothalamus, and thalamic nuclei, and from there to several cortical regions (e.g. auditory, visual, motor cortices).The trigeminal ganglion appears to amplify and perpetuate the migraine headache pain through the activation of perivascular fibers and the release of molecules involved in pain generation, such as calcitonin gene-related peptide (CGRP). The α-isoform of CGRP, expressed in primary sensory neurons, is a potent vasodilator and has been implicated in migraine pathogenesis - CGRP levels are acutely elevated during migraine attacks, return to normal following treatment with triptan medications, and intravenous infusions of CGRP have been shown to trigger migraine-like headaches in migraine patients. In addition to its vasodilatory properties, CGRP appears to be a pronociceptive factor that modulates neuronal excitability to facilitate pain responses. Atogepant is an antagonist of the calcitonin gene-related peptide receptor- it competes with CGRP for occupancy at these receptors, preventing the actions of CGRP and its ability to induce and perpetuate migraine headache pain. |
| Pharmacodynamics | Atogepant helps to prevent migraine headaches by antagonizing the activity of a pronociceptive molecule (CGRP) which has been implicated in migraine pathophysiology.Intended for preventative use, rather than abortive migraine therapy, atogepant is administered once daily. While no dose adjustments are required for patients with mild or moderate hepatic impairment, atogepant should be avoided in patients with severe hepatic impairment. Similarly, no dose adjustments are required for patients with mild or moderate renal impairment, but patients with severe renal impairment should be limited to a maximum daily dose of 10mg. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Calcitonin gene-related peptide type 1 receptor | Humans | antagonist |
ADME / PK
| Absorption | The time to peak plasma concentration following oral administration is approximately 2-3 hours.Atogepant displays dose-proportional pharmacokinetics up to approximately 3-fold its recommended maximum dosage, and its pharmacokinetics are not significantly influenced by co-administration with food. |
|---|---|
| Half-life | The elimination half-life of atogepant following oral administration is approximately 11 hours. |
| Protein binding | Atogepant is extensively (~95.3%) protein-bound in plasma. |
| Metabolism | The metabolism of atogepant is mediated primarily via CYP3A4.The most prevalent circulating compounds in plasma are atogepant itself and a glucuronide conjugate metabolite (M23),comprising approximately 75% and 15% of the administered dose, respectively,with at least 10 other metabolites detected in feces representing <10% of the administered dose. |
| Route of elimination | The elimination of atogepant occurs primarily via metabolism by CYP3A4.Following a single oral dose of radiolabeled atogepant to healthy male subjects, 42% of the administered dose was recovered as unchanged parent drug in the feces and 5% as unchanged parent drug in the urine.In total, approximately 81% of the radioactivity was recovered in the feces, with only 8% recovered in the urine. |
| Volume of distribution | The mean apparent volume of distribution of atogepant is 292 L. |
| Clearance | The mean apparent oral clearance of atogepant is approximately 19 L/h. |
Formulation & handling
- Solid small‑molecule API with low aqueous solubility, suggesting the need for solubility‑enhancing technologies for oral tablet formulations.
- Moderate lipophilicity (LogP 3.5) may support use of lipidic or polymeric carriers to optimize dissolution and absorption.
- Food has minimal impact on pharmacokinetics, allowing flexible administration without special formulation adjustments for fed/fasted conditions.
Regulatory status
| Lifecycle | The API is protected by multiple U.S. patents expiring between 2031 and 2035, indicating a market still in the protected phase. With commercialization in the EU, Canada, and the US, it remains in an early‑to‑mid lifecycle stage prior to anticipated generic entry. |
|---|
| Markets | EU, Canada, US |
|---|
Supply Chain
| Supply chain summary | Atogepant is supplied by a single originator, with branded products available across the US, EU, and Canada, indicating established global distribution by the innovator. Current patents extending into the early‑ to mid‑2030s suggest that the product remains within its protected period in major markets. As a result, significant generic API or finished‑dose competition is unlikely until approaching those expiry dates. |
|---|
Safety
| Toxicity | There are no data regarding overdosage with atogepant. Symptoms of atogepant overdose are likely to be consistent with its adverse effect profile and may therefore include significant gastrointestinal effects, such as nausea and constipation, as well as fatigue and somnolence.A single oral dose of 300mg (5x the maximum recommended dose) did not result in any serious adverse events and did not appear to impact cardiac function. |
|---|
- Overexposure may elicit gastrointestinal reactions aligned with the compound’s adverse‑effect profile, including nausea and constipation, as well as fatigue and somnolence
- Single‑dose data up to 300 mg (approximately fivefold the recommended maximum) showed no serious adverse events and no measurable impact on cardiac function
- Routine handling should consider the potential for CNS‑related effects (e
Atogepant is a type of CGRP antagonists
CGRP antagonists, also known as Calcitonin Gene-Related Peptide antagonists, belong to a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various neurological disorders, particularly migraines. CGRP is a neuropeptide that plays a crucial role in pain transmission and inflammation modulation. By inhibiting the CGRP receptors, these antagonists effectively alleviate migraine symptoms.
CGRP antagonists have gained significant attention in recent years due to their targeted approach and potential for fewer side effects compared to traditional migraine medications. They are designed to block the binding of CGRP to its receptors, thus preventing the activation of pain pathways. This mechanism helps reduce the frequency, duration, and severity of migraines.
These APIs are typically produced through chemical synthesis or biotechnological methods, ensuring their purity and potency. Several CGRP antagonists have received regulatory approval and are available in the market as prescription medications for migraine management. These drugs are administered either orally or via injections, depending on the specific formulation.
Research and development efforts in the field of CGRP antagonists continue to expand as pharmaceutical companies strive to develop novel and more effective formulations. Ongoing clinical trials aim to explore their potential in treating other conditions such as cluster headaches and post-traumatic headaches.
Overall, CGRP antagonists represent a promising class of pharmaceutical APIs that offer targeted relief for migraines and hold potential for broader applications in the field of neurology.
Atogepant (CGRP antagonists), 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.
Atogepant API manufacturers & distributors
Compare qualified Atogepant API suppliers worldwide. We currently have 3 companies offering Atogepant API, with manufacturing taking place in 2 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, CoA, GMP, MSDS | 229 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, GMP, MSDS, WC | 170 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, USDMF | 762 products |
When sending a request, specify which Atogepant 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 Atogepant 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 Atogepant API
Sourcing
What matters most when sourcing GMP-grade Atogepant?
Which documents are typically required when sourcing Atogepant API?
Which manufacturers are known to produce Atogepant API?
How can I request quotes for Atogepant API from GMP suppliers?
Is a GMP audit report available for Atogepant manufacturers?
How many suppliers offer Atogepant API on Pharmaoffer?
Which countries are known to manufacture Atogepant API?
Which certifications do suppliers of Atogepant usually hold?
Technical
What is Atogepant (CAS 1374248-81-3) used for?
Which therapeutic class does Atogepant fall into?
What conditions is Atogepant mainly prescribed for?
How does Atogepant work?
What should someone know about the safety or toxicity profile of Atogepant?
What are important formulation and handling considerations for Atogepant as an API?
Is Atogepant a small molecule?
Are there special stability concerns for oral Atogepant?
Regulatory
Where is Atogepant approved or in use globally?
What’s the regulatory and patent landscape for Atogepant right now?
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Atogepant procurement?
Is Atogepant included in the PRO Data Insights coverage?
Where can I access the API market report for Atogepant?
