Rykindo FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 17, 2023.

FDA Approved: Yes (First approved January 13, 2023)
Brand name: Rykindo
Generic name: risperidone
Dosage form: for Extended-Release Injectable Suspension
Company: Luye Pharma Group
Treatment for: Schizophrenia, Bipolar Disorder

Rykindo (risperidone) is a long-acting injection formulation of the approved atypical antipsychotic risperidone for the treatment of schizophrenia and bipolar I disorder in adults.

• Rykindo is indicated for use in adults for the treatment of schizophrenia, and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder.
• Rykindo contains risperidone, an atypical antipsychotic first FDA-approved under the brand names Risperdal, which is available in tablet and oral solution formulations, and Risperdal Consta which is a long-acting injection formulation administered every two weeks. Risperidone is thought to work through a combination of dopamine Type 2 (D₂) and serotonin Type 2 (5HT₂) receptor antagonism.
• Rykindo utilizes Luye Pharma's microsphere technology to deliver long-acting and extended-release risperidone.
• Rykindo is administered via intramuscular injection once every two weeks.
• Warnings and precautions associated with Rykindo include cerebrovascular adverse reactions in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, tardive dyskinesia, metabolic changes, hyperprolactinemia, orthostatic hypotension and syncope, low white blood cell count, potential for cognitive and motor impairment, and seizures.
• Common adverse reactions in patients with schizophrenia include headache, parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremity, and dry mouth.
  Common adverse reactions in patients with bipolar disorder include weight gain, tremor and parkinsonism.

Development timeline for Rykindo

Further information

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