Reagila (Cariprazine)
Atypical antipsychotic for the treatment of schizophrenia in adults
Reagila (cariprazine) is an atypical antipsychotic medication approved in the European Union for the treatment of schizophrenia in adults. It works as a partial agonist at dopamine D3 and D2 receptors, with a unique preference for D3 receptors that may offer advantages for treating both positive and negative symptoms. Reagila is available as hard capsules in strengths of 1.5 mg, 3 mg, 4.5 mg, and 6 mg, and is taken once daily by mouth.
Quick Facts
Key Takeaways
- Reagila (cariprazine) is a prescription atypical antipsychotic approved for schizophrenia treatment in adults, with a unique mechanism of action involving preferential dopamine D3 receptor partial agonism.
- The starting dose is 1.5 mg once daily, with gradual increases up to a maximum of 6 mg daily based on clinical response and tolerability.
- The most common side effects are akathisia (restlessness) and parkinsonism; metabolic monitoring including weight, blood glucose, and lipids is recommended.
- Reagila has numerous significant drug interactions, particularly with strong CYP3A4 inhibitors and inducers, which are contraindicated.
- Women of childbearing age must use effective contraception during treatment and for at least 10 weeks after stopping, due to the medication's long half-life.
What Is Reagila and What Is It Used For?
Quick Answer: Reagila contains the active substance cariprazine and belongs to a group of medicines called atypical antipsychotics. It is approved by the European Medicines Agency (EMA) for treating schizophrenia in adults. In the United States, cariprazine is marketed under the brand name Vraylar and has additional indications.
Reagila (cariprazine) is a second-generation (atypical) antipsychotic medication developed by Gedeon Richter Plc. and approved by the European Medicines Agency in 2017 for the treatment of schizophrenia in adult patients. Schizophrenia is a chronic and severe mental health disorder that affects approximately 1% of the global population, according to the World Health Organization (WHO). The condition is characterized by distortions in thinking, perception, emotions, language, sense of self, and behavior.
Patients with schizophrenia may experience positive symptoms such as hallucinations (hearing, seeing, or sensing things that are not present), delusions (firmly held false beliefs), and disorganized speech and behavior. They may also suffer from negative symptoms, including emotional blunting, social withdrawal, lack of motivation, reduced speech output, and an inability to experience pleasure. Cariprazine's unique pharmacological profile, particularly its preferential binding to dopamine D3 receptors, may offer particular benefits for addressing negative symptoms, which have historically been difficult to treat with conventional antipsychotics.
The mechanism of action of cariprazine involves partial agonism at dopamine D3 and D2 receptors, as well as serotonin 5-HT1A receptors. It also acts as an antagonist at serotonin 5-HT2A and 5-HT2B receptors. This multi-receptor binding profile helps modulate dopaminergic and serotonergic neurotransmission in key brain regions involved in psychosis, mood regulation, and cognitive function. Unlike many other antipsychotics, cariprazine has approximately 10-fold higher affinity for D3 receptors compared to D2 receptors, which is believed to contribute to its distinct clinical effects.
Cariprazine has a notably long effective half-life due to its two active metabolites: desmethyl-cariprazine (DCAR) and didesmethyl-cariprazine (DDCAR). DDCAR has a half-life of approximately 2 to 4 weeks, meaning that the pharmacological effects of cariprazine persist for a considerable period after discontinuation. This characteristic has implications for dose adjustments, drug interactions, and the required duration of contraception after treatment cessation.
In the United States, cariprazine is marketed as Vraylar and is FDA-approved for schizophrenia, bipolar I disorder (manic and mixed episodes), and as adjunctive therapy for major depressive disorder. The EU approval (as Reagila) is currently limited to schizophrenia. Clinical trials are ongoing for additional indications in both regions.
What Should You Know Before Taking Reagila?
Quick Answer: Before starting Reagila, inform your doctor about all medical conditions, current medications, and whether you are pregnant or planning to become pregnant. Reagila is contraindicated with several medications that affect its metabolism, and special precautions are needed for patients with cardiovascular disease, diabetes risk factors, or a history of seizures.
Understanding the contraindications, warnings, and precautions associated with Reagila is essential for safe and effective treatment. As with all antipsychotic medications, cariprazine requires careful medical supervision and regular monitoring throughout the course of therapy. Your prescribing physician will assess your individual risk factors and determine whether Reagila is appropriate for your situation.
Contraindications
You must not take Reagila if you are allergic to cariprazine or any of the other ingredients in the capsules. Additionally, Reagila is contraindicated in patients who are taking the following medications, as they can dangerously alter cariprazine blood levels:
- Hepatitis C antivirals: boceprevir, telaprevir
- Certain antibiotics: clarithromycin, telithromycin, nafcillin
- Tuberculosis medications: rifampicin
- HIV antivirals: cobicistat, indinavir, nelfinavir, ritonavir, saquinavir, efavirenz, etravirine
- Antifungal agents: itraconazole, posaconazole, voriconazole
- Cushing's syndrome treatment: ketoconazole
- Antidepressants and herbal remedies: nefazodone, St John's wort (Hypericum perforatum)
- Antiepileptic drugs: carbamazepine, phenobarbital, phenytoin
- Wakefulness-promoting agents: modafinil
- Pulmonary hypertension treatment: bosentan
These contraindications exist because the medications listed above are either strong inhibitors or strong inducers of the cytochrome P450 3A4 (CYP3A4) enzyme system, which is the primary metabolic pathway for cariprazine. Strong CYP3A4 inhibitors can dramatically increase cariprazine blood levels, raising the risk of serious adverse effects, while strong CYP3A4 inducers can reduce cariprazine levels to sub-therapeutic concentrations, rendering the treatment ineffective.
Warnings and Precautions
- Suicidal thoughts or self-harm urges — these are more likely in the early stages of treatment
- Neuroleptic malignant syndrome (NMS) — a rare but life-threatening reaction characterized by fever, sweating, muscle rigidity, altered consciousness, and rapid heartbeat
Speak with your doctor or pharmacist before taking Reagila, or during treatment, if any of the following apply to you:
- Akathisia: You experience or develop restlessness or an inability to sit still, which can occur early during treatment.
- Tardive dyskinesia: You experience abnormal, involuntary movements, particularly of the tongue or face. This may occur after short-term or long-term use.
- Visual disturbances: If you experience impaired vision, your doctor will refer you to an ophthalmologist for evaluation.
- Cardiac conditions: If you have irregular heartbeat, a family history of QT prolongation (as detected on ECG), or are taking other medications that may affect heart rhythm.
- Blood pressure abnormalities: High or low blood pressure, cardiovascular disease, or orthostatic hypotension (dizziness upon standing) require regular monitoring.
- Thromboembolic risk: A personal or family history of blood clots, as antipsychotic medications have been associated with venous thromboembolism.
- Cerebrovascular history: Previous stroke, especially in elderly patients or those with additional risk factors.
- Dementia: Reagila should not be used in elderly patients with dementia-related psychosis due to increased risk of cerebrovascular events and mortality.
- Parkinson's disease: Antipsychotics can worsen parkinsonian symptoms.
- Diabetes or metabolic risk: Reagila can elevate blood glucose levels. Regular monitoring of blood sugar, weight, and lipid profiles is recommended.
- Seizure history: Cariprazine may lower the seizure threshold.
Reagila can cause significant weight gain, which may adversely affect overall health and cardiovascular risk. Your doctor should monitor your weight at regular intervals throughout treatment. Metabolic parameters including fasting glucose, insulin levels, and lipid panel should be assessed at baseline and periodically during therapy, in accordance with current psychiatric treatment guidelines.
Pregnancy and Breastfeeding
Women of childbearing potential must use effective contraception during treatment with Reagila. Importantly, contraception must be continued for at least 10 weeks after the last dose, because the active metabolites of cariprazine remain in the body for a prolonged period. This extended washout requirement is unique among antipsychotics and reflects the very long half-life of the didesmethyl-cariprazine (DDCAR) metabolite.
Reagila should not be used during pregnancy unless the prescribing physician considers it essential. Neonates exposed to antipsychotic medications during the third trimester are at risk of extrapyramidal symptoms and/or withdrawal symptoms after delivery, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding difficulties. These symptoms may vary in severity from self-limiting to requiring intensive care.
Breastfeeding is not recommended during treatment with Reagila, as cariprazine may pass into breast milk and pose a risk to the infant. Discuss alternative feeding options with your healthcare provider.
Driving and Operating Machinery
Reagila may have a minor to moderate influence on the ability to drive and use machines. Drowsiness, dizziness, and visual disturbances can occur during treatment. Patients should not drive or operate machinery until they have established how Reagila affects them individually. This is particularly important during the initial dose titration phase and when dose adjustments are made.
The 3 mg, 4.5 mg, and 6 mg capsule strengths contain allura red AC (E 129), a coloring agent that may cause allergic reactions in susceptible individuals. The 1.5 mg capsules do not contain this dye.
How Does Reagila Interact with Other Drugs?
Quick Answer: Reagila has significant interactions with medications that inhibit or induce the CYP3A4 enzyme. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) and strong CYP3A4 inducers (e.g., carbamazepine, rifampicin, St John's wort) are contraindicated. Moderate interactions may require dose adjustments. Grapefruit juice should be avoided.
Drug interactions with cariprazine are primarily mediated through the cytochrome P450 3A4 (CYP3A4) enzyme system, which is the main pathway for its metabolism. Understanding these interactions is critical for patient safety, as altered drug levels can lead to either treatment failure or increased toxicity. Always inform your doctor and pharmacist about all medications, supplements, and herbal products you are taking.
Major Interactions (Contraindicated)
The following medications must not be taken concomitantly with Reagila. These are classified as major interactions because they can cause dangerous changes in cariprazine plasma concentrations:
| Drug | Category | Mechanism | Effect |
|---|---|---|---|
| Ketoconazole | Antifungal | Strong CYP3A4 inhibitor | Dangerously increases cariprazine levels |
| Itraconazole | Antifungal | Strong CYP3A4 inhibitor | Dangerously increases cariprazine levels |
| Clarithromycin | Antibiotic | Strong CYP3A4 inhibitor | Dangerously increases cariprazine levels |
| Ritonavir | HIV Antiviral | Strong CYP3A4 inhibitor | Dangerously increases cariprazine levels |
| Carbamazepine | Antiepileptic | Strong CYP3A4 inducer | Reduces cariprazine to sub-therapeutic levels |
| Rifampicin | Anti-tuberculosis | Strong CYP3A4 inducer | Reduces cariprazine to sub-therapeutic levels |
| St John's Wort | Herbal supplement | Strong CYP3A4 inducer | Reduces cariprazine to sub-therapeutic levels |
| Phenytoin | Antiepileptic | Strong CYP3A4 inducer | Reduces cariprazine to sub-therapeutic levels |
Moderate Interactions (Dose Adjustment May Be Needed)
When Reagila is taken together with certain moderate CYP3A4 inhibitors or substrates, dose adjustments of either Reagila or the co-administered medication may be necessary. These include:
| Drug | Category | Clinical Consideration |
|---|---|---|
| Erythromycin | Antibiotic | Moderate CYP3A4 inhibitor; monitor for increased side effects |
| Fluconazole | Antifungal | Moderate CYP3A4 inhibitor; dose reduction may be needed |
| Diltiazem | Cardiovascular | Moderate CYP3A4 inhibitor; monitor cardiac function |
| Verapamil | Cardiovascular | Moderate CYP3A4 inhibitor; monitor cardiac function |
| Digoxin | Cardiac glycoside | P-glycoprotein substrate; monitor digoxin levels |
| Dabigatran | Anticoagulant | P-glycoprotein substrate; monitor for bleeding |
Grapefruit juice: Must be avoided during treatment, as it is a moderate CYP3A4 inhibitor and can increase cariprazine levels. Alcohol: Should be avoided as it may potentiate the sedative effects of cariprazine and impair cognitive and motor function. Reagila can be taken with or without food.
Cariprazine should be used with caution when combined with other medications that affect central nervous system function, including other antipsychotics, sedatives, anxiolytics, and opioid analgesics. The combined use of multiple CNS-active agents can increase the risk of sedation, respiratory depression, and falls, particularly in elderly patients.
What Is the Correct Dosage of Reagila?
Quick Answer: The recommended starting dose of Reagila is 1.5 mg once daily, taken orally with or without food. The dose may be gradually increased in 1.5 mg increments based on clinical response. The maximum daily dose is 6 mg. Always take Reagila at the same time each day and never adjust the dose without consulting your doctor.
Dosing of Reagila should be individualized based on clinical response, tolerability, and the patient's overall medical condition. The prescribing physician will determine the appropriate dose and any necessary adjustments. Due to the long half-life of cariprazine's active metabolites, changes in plasma concentration occur gradually, and the full effect of a dose change may not be apparent for several weeks.
Adults
Standard Adult Dosing (Schizophrenia)
- Starting dose: 1.5 mg once daily
- Dose titration: May be increased in increments of 1.5 mg based on clinical response and tolerability
- Usual maintenance dose: 1.5 mg to 6 mg once daily
- Maximum dose: 6 mg once daily
- Administration: Swallow capsule whole, with or without food, at the same time each day
If you are switching from another antipsychotic medication to Reagila, your doctor will decide whether to gradually taper the previous medication or stop it immediately, and will guide the dose transition accordingly. Cross-titration strategies should be individualized based on the pharmacological properties of both the outgoing and incoming medications.
Children and Adolescents
Reagila is not recommended for children and adolescents under 18 years of age. There is insufficient clinical data on the safety and efficacy of cariprazine in this population. The EMA has deferred the obligation to submit results of studies in pediatric patients with schizophrenia.
Elderly Patients
No specific dose adjustment is required for elderly patients based solely on age. However, the prescribing physician should carefully select an appropriate dose, taking into account the individual patient's renal and hepatic function, concurrent medications, and overall clinical status. Reagila should not be used in elderly patients with dementia-related psychosis, as antipsychotic medications have been associated with an increased risk of cerebrovascular adverse events and mortality in this population.
Reagila may not be suitable for patients with severe kidney or liver problems. No dose adjustment is needed for mild to moderate renal or hepatic impairment, but close clinical monitoring is recommended. Discuss your kidney and liver function with your doctor before starting treatment.
Missed Dose
If you miss a dose of Reagila, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for a forgotten dose. If you miss two or more consecutive doses, contact your doctor for guidance, as a dose re-titration may be necessary.
Overdose
If you suspect an overdose of Reagila, or if a child has accidentally ingested the medication, seek emergency medical attention immediately. Bring the medication packaging with you. Symptoms of overdose may include dizziness due to low blood pressure, abnormal heart rhythm, drowsiness, fatigue, abnormal involuntary movements, and difficulty standing or walking. There is no specific antidote for cariprazine overdose; treatment is supportive and symptomatic, with continuous cardiovascular monitoring.
Do not change or stop taking Reagila without consulting your doctor, even if you feel well. Abrupt discontinuation may lead to a relapse of schizophrenia symptoms. Any dose changes should be made gradually under medical supervision.
What Are the Side Effects of Reagila?
Quick Answer: Like all medications, Reagila can cause side effects. The most common are akathisia (restlessness) and parkinsonism, affecting more than 1 in 10 patients. Other common side effects include anxiety, insomnia, dizziness, weight gain, and nausea. Rare but serious side effects include neuroleptic malignant syndrome, severe allergic reactions, and rhabdomyolysis. Report any concerning symptoms to your doctor promptly.
Understanding the potential side effects of Reagila helps patients and caregivers identify concerning symptoms early and seek appropriate medical attention. Not everyone will experience side effects, and many are mild and manageable. However, some adverse reactions require immediate medical intervention. The side effects listed below are based on clinical trial data and post-marketing surveillance.
- Severe allergic reaction: fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, and sometimes a drop in blood pressure (rare)
- Neuroleptic malignant syndrome: a combination of fever, sweating, muscle rigidity, and drowsiness or reduced consciousness (frequency unknown)
- Rhabdomyolysis: unexplained muscle pain, cramps, or weakness that may indicate muscle damage capable of causing severe kidney problems (rare)
- Blood clots: swelling, pain, and redness in a leg, which may travel to the lungs causing chest pain and breathing difficulty (frequency unknown)
- Suicidal thoughts or self-harm urges (uncommon)
Very Common
May affect more than 1 in 10 people
- Akathisia (restlessness and inability to sit still)
- Parkinsonism (slow or decreased movement, tremor, muscle stiffness, shuffling gait, reduced facial expression, drooling, cogwheel rigidity)
Common
May affect up to 1 in 10 people
- Anxiety, restlessness
- Insomnia, abnormal dreams, nightmares, sleepwalking
- Drowsiness, dizziness
- Extrapyramidal symptoms (involuntary twisting movements, teeth grinding, jaw clenching, excessive blinking, tongue movement disorders)
- Blurred vision
- High blood pressure
- Rapid or irregular heartbeat
- Decreased or increased appetite
- Nausea, vomiting, constipation
- Weight gain
- Fatigue
- Elevated liver enzymes, creatine phosphokinase, and blood lipids in laboratory tests
Uncommon
May affect up to 1 in 100 people
- Depression, confusion
- Vertigo (spinning sensation)
- Unpleasant or abnormal sense of touch
- Lethargy, lack of energy or interest
- Tardive dyskinesia (involuntary movements, particularly of the tongue or face)
- Decreased or increased sexual desire, erectile dysfunction
- Eye irritation, elevated intraocular pressure, impaired vision
- Low blood pressure, abnormal ECG, abnormal cardiac nerve impulses
- Slow or irregular heart rate
- Hiccups, heartburn, excessive thirst
- Painful or abnormally frequent urination
- Itching, skin rash
- Diabetes
- Abnormal blood sodium levels, elevated blood glucose and bilirubin
- Anemia, increased white blood cells
- Decreased thyroid-stimulating hormone (TSH)
Rare
May affect up to 1 in 1,000 people
- Seizures
- Memory loss, loss of speech ability
- Photosensitivity (eye discomfort in bright light)
- Cataracts (clouding of the eye lens leading to impaired vision)
- Difficulty swallowing
- Decreased white blood cells (increased infection susceptibility)
- Hypothyroidism (underactive thyroid)
Frequency Unknown
Reported from post-marketing experience
- Hepatitis (liver inflammation) — symptoms include pain in the upper right abdomen, yellowing of the eyes and skin, weakness, and fever
Weight gain is a clinically significant concern with many antipsychotic medications, including Reagila. Your healthcare provider should monitor your weight regularly, along with metabolic parameters such as fasting blood glucose, HbA1c, and lipid profile. If significant weight gain occurs, dietary counseling and lifestyle modifications should be discussed. In some cases, a change in medication may be warranted.
The long half-life of cariprazine's active metabolites means that side effects may persist for some time after the medication is discontinued. This is an important consideration when managing adverse reactions and when transitioning to alternative treatments.
How Should You Store Reagila?
Quick Answer: Store Reagila in the original packaging to protect from light. Keep it out of the sight and reach of children. No special temperature storage requirements. Do not use after the expiration date printed on the packaging.
Proper storage of medications is essential to maintain their effectiveness and safety throughout their shelf life. Reagila hard capsules should be stored according to the following guidelines:
- Keep out of sight and reach of children at all times. Consider using a locked medicine cabinet if children are present in the household.
- Store the blister in the outer carton to protect from light. Cariprazine capsules are light-sensitive, and exposure to direct light may degrade the active substance.
- No special temperature requirements — store at room temperature. Avoid extreme heat or freezing conditions.
- Do not use after the expiration date stated on the carton and blister packaging after "EXP." The expiration date refers to the last day of that month.
Do not dispose of medications via household waste or down the drain. Return unused or expired medications to a pharmacy for proper disposal. These measures help protect the environment from potential pharmaceutical contamination of water systems and soil.
What Does Reagila Contain?
Quick Answer: Each Reagila capsule contains cariprazine hydrochloride as the active ingredient (equivalent to 1.5, 3, 4.5, or 6 mg of cariprazine). Inactive ingredients include pregelatinized maize starch, magnesium stearate, gelatin, titanium dioxide, and various coloring agents depending on the capsule strength.
The active substance in all Reagila capsule strengths is cariprazine hydrochloride. Each capsule is formulated with the following amounts of active ingredient:
| Strength | Capsule Size | Appearance | Imprint |
|---|---|---|---|
| 1.5 mg | Size 4 (~14.3 mm) | White opaque cap and body | GR 1.5 (black) |
| 3 mg | Size 4 (~14.3 mm) | Green opaque cap, white opaque body | GR 3 (black) |
| 4.5 mg | Size 4 (~14.3 mm) | Green opaque cap and body | GR 4.5 (white) |
| 6 mg | Size 3 (~15.9 mm) | Purple opaque cap, white opaque body | GR 6 (black) |
All capsule strengths are filled with white to yellowish-white powder and contain the following inactive (excipient) ingredients:
- Common to all strengths: pregelatinized starch (maize), magnesium stearate, gelatin, titanium dioxide (E 171)
- 3 mg, 4.5 mg, 6 mg capsules additionally contain: allura red AC (E 129), brilliant blue FCF (E 133), yellow iron oxide (E 172)
- Printing ink: shellac, iron oxide black (E 172) or titanium dioxide (E 171), propylene glycol, potassium hydroxide or simeticone (depending on capsule strength)
Reagila is available in blister pack sizes of 7, 14, 21, 28, 30, 49, 56, 60, 84, 90, or 98 capsules (the 4.5 mg and 6 mg strengths are not available in a 14-capsule pack). Not all pack sizes may be marketed in all countries. The marketing authorization holder is Gedeon Richter Plc., based in Budapest, Hungary.
Frequently Asked Questions About Reagila
Reagila (cariprazine) is an atypical antipsychotic medication approved in the European Union for the treatment of schizophrenia in adults. It works by partially activating dopamine D3 and D2 receptors in the brain, which helps correct the imbalance of neurotransmitters that contributes to psychotic symptoms. In the United States, cariprazine is marketed as Vraylar and is also approved for bipolar I disorder (manic and depressive episodes) and as adjunctive therapy for major depressive disorder.
The most common side effects of Reagila (affecting more than 1 in 10 patients) are akathisia (a feeling of restlessness and inability to sit still) and parkinsonism (slow movements, tremor, muscle stiffness, reduced facial expression). Common side effects (up to 1 in 10 patients) include anxiety, insomnia, dizziness, nausea, constipation, weight gain, and fatigue. Most side effects are dose-dependent and may improve over time or with dose adjustment.
Reagila should not be used during pregnancy unless the potential benefit justifies the risk. Women of childbearing age must use effective contraception during treatment and for at least 10 weeks after the last dose, due to the very long half-life of cariprazine's active metabolites. Babies born to mothers who took antipsychotics during the third trimester may experience withdrawal symptoms. Breastfeeding is not recommended during Reagila treatment. Always discuss family planning with your doctor before starting or during treatment.
Reagila (cariprazine) is unique among antipsychotics because of its preferential binding to dopamine D3 receptors, with approximately 10-fold higher affinity for D3 than D2 receptors. This pharmacological profile may contribute to improved efficacy against negative symptoms of schizophrenia (such as social withdrawal, reduced motivation, and emotional blunting), which are generally poorly addressed by other antipsychotics. Additionally, cariprazine has a very long effective half-life (2-4 weeks for the DDCAR metabolite), providing stable plasma levels but requiring extended contraception after discontinuation.
If you miss a dose, take it as soon as you remember. If it is nearly time for your next dose, skip the missed dose and continue with your regular schedule. Never take a double dose to make up for a forgotten one. If you miss two or more consecutive doses, contact your doctor, as a gradual dose re-titration may be needed. Due to cariprazine's long half-life, a single missed dose is unlikely to cause immediate problems, but consistent daily dosing is important for optimal therapeutic benefit.
Reagila must not be taken with strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, boceprevir, telaprevir, nefazodone) or strong CYP3A4 inducers (such as carbamazepine, phenobarbital, phenytoin, rifampicin, nafcillin, modafinil, bosentan, efavirenz, etravirine, and St John's wort). Grapefruit juice should also be avoided. Some moderate interacting drugs (erythromycin, fluconazole, diltiazem, verapamil) may require dose adjustments rather than complete avoidance.
References
This article is based on the following peer-reviewed sources, clinical guidelines, and regulatory documents:
- European Medicines Agency (EMA). Reagila (cariprazine) — Summary of Product Characteristics (SmPC). Last updated January 2026. Available at: EMA — Reagila EPAR.
- Nemeth G, Laszlovszky I, Czobor P, et al. Cariprazine versus risperidone monotherapy for treatment of predominant negative symptoms in patients with schizophrenia: a randomised, double-blind, controlled trial. The Lancet. 2017;389(10074):1103-1113. doi:10.1016/S0140-6736(17)30060-0.
- Citrome L. Cariprazine in schizophrenia: clinical efficacy, tolerability, and place in therapy. Advances in Therapy. 2019;36(12):3319-3331. doi:10.1007/s12325-019-01121-6.
- American Psychiatric Association (APA). Practice Guidelines for the Treatment of Patients with Schizophrenia. 3rd edition. 2021.
- National Institute for Health and Care Excellence (NICE). Psychosis and Schizophrenia in Adults: Prevention and Management. Clinical Guideline CG178. Updated 2024.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd edition. 2023.
- Stahl SM. Stahl's Essential Psychopharmacology: Neuroscientific Basis and Practical Applications. 5th edition. Cambridge University Press; 2021.
- Kiss B, Horváth A, Némethy Z, et al. Cariprazine (RGH-188), a dopamine D3 receptor-preferring, D3/D2 dopamine receptor antagonist-partial agonist antipsychotic candidate. Journal of Pharmacology and Experimental Therapeutics. 2010;333(1):328-340. doi:10.1124/jpet.109.164434.
Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising board-certified specialists in psychiatry and psychopharmacology. All medical content follows the GRADE evidence framework and is reviewed against current international treatment guidelines from the EMA, APA, NICE, and WHO.
Written by medical professionals with expertise in psychopharmacology and mental health. Based on the European Medicines Agency approved Summary of Product Characteristics, international clinical guidelines, and peer-reviewed research.
Independently reviewed by the iMedic Medical Review Board. Verified for clinical accuracy, completeness, and adherence to evidence-based medicine standards. No commercial funding or pharmaceutical sponsorship.