Simtriyo (Centanafadine Capsules)

Simtriyo (centanafadine) is a norepinephrine-dopamine-serotonin reuptake inhibitor (NDSRI) and central nervous system (CNS) stimulant indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older weighing at least 20 kg.

ADHD is a chronic neurodevelopmental condition marked by persistent patterns of inattention, hyperactivity, and impulsivity that interfere with functioning or development across home, school, and work settings. It is one of the most commonly diagnosed neurodevelopmental disorders in children and also affects a substantial number of adults, often continuing to impact organization, focus, mood, and executive functioning throughout adulthood.

Simtriyo (centanafadine) works by inhibiting the reuptake of norepinephrine, dopamine, and serotonin, thereby increasing the availability of these neurotransmitters in brain pathways involved in attention and behavior regulation. It is the first and only approved norepinephrine-dopamine-serotonin reuptake inhibitor (NDSRI), introducing a novel treatment mechanism distinct from traditional stimulant and non-stimulant ADHD therapies.

Limitations of Use:
The use of Simtriyo (centanafadine) is not recommended in pediatric patients:

• Younger than 6 years of age, as this subpopulation showed a higher incidence of weight loss compared with pediatric patients 6 years of age and older
• Weighing less than 20 kg, due to a lack of clinical data in this subpopulation and the associated risk of weight loss

Simtriyo (centanafadine) is a prescription CNS stimulant and should only be used under the supervision of a qualified physician, psychiatrist, or pediatrician experienced in the diagnosis and management of ADHD.

Recommended Dosage:
Simtriyo (centanafadine) is administered orally once daily, with dosing individualized based on age, body weight, and clinical response, in line with the approved prescribing information.

• Adults: Dosing typically follows a titration schedule up to the maintenance strength (commonly 210 mg or 280 mg once daily), as directed by the prescribing physician.
• Pediatric patients (6 years and older, weighing at least 20 kg): Dosing is weight-based, with strength selected according to the patient’s body weight and titrated as clinically appropriate.

Patients and caregivers should not adjust the dose or discontinue therapy without consulting the treating physician. If a dose is missed, patients should follow the specific instructions provided by their prescribing doctor rather than doubling the next dose.

• Simtriyo is a Schedule-controlled CNS stimulant with an associated potential for abuse and dependence. It should be prescribed and dispensed with appropriate caution, particularly in patients with a history of substance use disorder.
• In pediatric patients, the most commonly reported adverse reactions included rash, decreased appetite, nausea, headache, and abdominal pain. In adults, the most common adverse reactions included headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea.
• Patients and caregivers should monitor for signs of appetite suppression and unexpected weight loss, particularly in pediatric patients, and should inform the treating physician promptly if these occur. Growth (height and weight) should be monitored periodically in pediatric patients during long-term treatment, as advised by the physician.
• As with other CNS stimulants, patients should be evaluated for pre-existing cardiovascular conditions before starting therapy, and blood pressure and heart rate should be monitored periodically during treatment. Simtriyo should be used with caution in patients with a history of psychiatric illness, including psychosis, mania, or significant mood disorders, as stimulant medicines may worsen these conditions.
• There is limited data on the use of Simtriyo during pregnancy or breastfeeding. Women who are pregnant, planning pregnancy, or breastfeeding should discuss the potential risks and benefits with their treating physician before starting or continuing treatment.
• Before starting treatment with Centanafadine, patients should inform their healthcare provider about all other prescription medicines, over-the-counter medicines, and supplements they are taking, including other stimulants, antidepressants, or medicines affecting serotonin levels, to avoid potential drug interactions.

What documents are required to import SIMTRIYO to India?

SIMTRIYO (centanafadine) may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a qualified doctor
• The patient’s diagnostic/clinical evaluation reports
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription from the doctor and an import permit, if applicable — noting that, as a controlled CNS stimulant, additional narcotics/psychotropic import documentation may apply depending on prevailing regulations.

Is SIMTRIYO available in India?

SIMTRIYO (centanafadine capsules) is a prescription medicine that legally requires a doctor’s prescription to be dispensed. As of the current publicly available information, Simtriyo is not commercially marketed in India.

However, patients in India can legally access SIMTRIYO through the Named Patient Program (NPP) — an import provision that allows a medicine not yet registered in India to be imported in the name of an individual patient, on the prescription of their treating physician.

Indian Pharma Network (IPN) acts as a facilitator under named patient supply, providing input on:
Availability of Simtriyo in India (Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Pune, etc.) and pathways to access it

• Availability in Gulf countries (Bahrain, Oman, Qatar, Kuwait, Iraq, Saudi Arabia, and the UAE)
• Simtriyo price in India under the NPP route
• Sourcing from genuine, reliable channels in the USA, Canada, Europe, and Australia
• Ensuring full transparency throughout the process

SIMTRIYO can be made available to patients, doctors, and hospitals in Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient’s treating hospital or clinic. Orders are confirmed only after receipt of a valid doctor’s prescription and an import permit, where applicable.

Global Approval Status:

Simtriyo (centanafadine) received FDA approval on July 24, 2026, based on four Phase 3 clinical trials conducted in children, adolescents, and adults, which demonstrated statistically significant improvements in ADHD symptoms compared with placebo.

• United States: The U.S. FDA approved Simtriyo (centanafadine) as the first-in-class norepinephrine-dopamine-serotonin reuptake inhibitor for the treatment of ADHD in adults and pediatric patients aged 6 years and older. The medicine is expected to require DEA scheduling before commercial launch in the United States.
• Other Countries: As of the current publicly available information, Simtriyo has not yet received marketing approval in India. Approval status in Europe, the United Kingdom, Australia, Canada, Japan, and other countries may vary as regulatory reviews continue. Patients should consult local regulatory authorities or healthcare providers regarding country-specific availability.

The approval was supported by four randomized, double-blind, placebo-controlled Phase 3 clinical trials evaluating centanafadine’s efficacy and safety in children, adolescents, and adults with ADHD. The Phase 3 program included two trials in adults, one in adolescents, and one in children, along with post hoc analyses that showed improvements in patient-reported executive function and emotional regulation. Centanafadine represents Otsuka’s next major CNS launch, expanding its portfolio in a large and historically underserved ADHD market.

Centanafadine was discovered and developed by Otsuka Pharmaceutical. Continued global availability and additional country-specific approvals are expected to be confirmed as regulatory submissions progress in other markets.

Note: Approval and marketing status vary by country. As of the current publicly available information, Simtriyo is not approved or commercially marketed in India.

Indian Pharma Network (IPN) can source Simtriyo from reliable channels across the world and facilitate supply to patients, doctors, and hospitals, offering worldwide access to this treatment under applicable legal provisions. All prescriptions are dispensed and checked by registered pharmacists and dispatched to the patient’s address from New Delhi, India, after legal requirements are fulfilled.

For Simtriyo cost in India and availability, contact IPN at WhatsApp: +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@indianpharmanetwork.in.

What is the generic name for the brand drug Simtriyo?

Centanafadine is the generic name for the brand drug Simtriyo.

What is Simtriyo used for?

Simtriyo (centanafadine) is indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older weighing at least 20 kg. It is not recommended for children younger than 6 years or those weighing less than 20 kg, due to a higher risk of weight loss and a lack of supporting data in these groups.

Who develops and manufactures Simtriyo?

Simtriyo (centanafadine) was developed and is manufactured by Otsuka Pharmaceutical, a global pharmaceutical company with an established CNS/neuroscience portfolio.

What type of medicine is Simtriyo?

Simtriyo is a first-in-class norepinephrine-dopamine-serotonin reuptake inhibitor (NDSRI) and CNS stimulant, working by increasing the availability of three key neurotransmitters involved in attention and behavior.

Is Simtriyo approved by the FDA?

Yes. Simtriyo (centanafadine) received FDA approval on July 24, 2026, based on four Phase 3 clinical trials.

Where is Simtriyo approved?

As of current publicly available information, Simtriyo has been approved in the United States by the FDA. Regulatory submissions or reviews in other countries, including India, may still be ongoing.

What strength and dosage form is available?

Simtriyo is supplied as an oral extended-release capsule, in multiple strengths (140 mg, 210 mg, and 280 mg) to allow weight-based dosing in pediatric patients and fixed dosing in adults, as directed by the prescribing physician.

What are the most common side effects of Simtriyo?

The most commonly reported side effects in children include rash, decreased appetite, nausea, headache, and abdominal pain, while in adults the most common reactions include headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea.

How does Simtriyo import in India work?

Simtriyo import in India is possible through the Named Patient Program (NPP) — on behalf of an individual patient with a valid doctor’s prescription. Indian Pharma Network (IPN) helps manage the process, including documentation, approvals, and delivery, so the medicine reaches the patient safely and legally.

Who is a reliable Simtriyo supplier in India?

Indian Pharma Network (IPN) facilitates compliant access to Simtriyo in India through global sourcing channels and structured documentation support for eligible patients, in accordance with applicable regulatory provisions.

How much does Simtriyo cost in India?

Simtriyo (centanafadine) is not yet approved or marketed in India, but eligible patients can legally access it through the Named Patient Program. Prices may vary over time due to market, currency, and regulatory factors. For the latest centanafadine cost in India, call +91 96548 60915 or WhatsApp +91 98104 69557 or email info@indianpharmanetwork.in.

Can Simtriyo be accessed in SAARC countries?

Yes. In addition to Gulf countries, Simtriyo can be accessed through import provisions such as the Named Patient Program in SAARC countries (India, Afghanistan, Maldives, Nepal, Bangladesh, Bhutan, Pakistan, and Sri Lanka). IPN can help facilitate compliant supply where permitted by local regulations.

Is it safe to buy Simtriyo Capsules online in India?

Yes, one can buy Simtriyo in India through the Indian Pharma Network (IPN), as this product is not yet registered or commercially available in the country. IPN can help facilitate the import of Simtriyo through legal channels.

Can Simtriyo be delivered to my treating hospital or clinic?

Yes. IPN can facilitate delivery of Simtriyo to the patient’s treating hospital or clinic across major Indian cities, under the Named Patient Program, with a valid doctor’s prescription and import permit where applicable. Leading hospitals and centres include AIIMS Delhi, Sir Ganga Ram Hospital, Medanta – The Medicity, Apollo Hospitals Chennai, Christian Medical College (CMC), PGIMER, NIMHANS, Fortis Memorial Research Institute, Kokilaben Dhirubhai Ambani Hospital, Manipal Hospitals, Max Healthcare, Bombay Hospital, Lilavati Hospital, Care Hospitals, Yashoda Hospitals, Aster Medcity, King George’s Medical University (KGMU), Amrita Hospital, Artemis Hospital, Kauvery Hospital, Sri Ramachandra Medical Centre, and Indraprastha Apollo Hospital.

What are the storage conditions for Simtriyo Capsules?

Simtriyo should be stored at room temperature, protected from moisture, as specified in the official prescribing information provided with the product. Patients should keep the medicine out of reach of children and follow specific storage guidance from the dispensing pharmacist.

Disclaimer: Simtriyo (centanafadine) is a prescription CNS stimulant medicine and should only be used under the supervision of a qualified healthcare professional. Product availability, regulatory approvals, and import requirements vary by country. This medicine is intended for adults and pediatric patients 6 years of age and older weighing at least 20 kg, in accordance with the approved indication and eligibility criteria; it is not recommended for children younger than 6 years or weighing less than 20 kg. Information provided on this page is intended for educational purposes only and should not be considered medical advice, a substitute for professional healthcare consultation, or a recommendation to self-medicate. Patients should always consult their treating physician regarding diagnosis, treatment options, and eligibility for access through the Named Patient Program.