We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Reagila
Published
Product name
Reagila
Active ingredient
Cariprazine hydrochloride
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Reagila (cariprazine hydrochloride) was approved for the following therapeutic use:
Reagila is indicated for the treatment of schizophrenia in adult patients.
How this medicine works
Reagila is an atypical antipsychotic. The mechanism of action of cariprazine, as with other medicines having efficacy in schizophrenia, is not fully understood. However, the therapeutic effect of cariprazine may be mediated through a combination of partial agonist activity at dopamine D3, D2L and D2S receptors and serotonin 5-HT1A receptors, and antagonist activity at serotonin 5-HT2B, 5-HT2A and histamine H1 receptors.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Reagila was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- REAGILA cariprazine (as hydrochloride) 6 mg hard capsule blister pack (325476)
- REAGILA cariprazine (as hydrochloride) 1.5 mg hard capsule blister pack (325477)
- REAGILA cariprazine (as hydrochloride) 3 mg hard capsule blister pack (325478)
- REAGILA cariprazine (as hydrochloride) 4.5 mg hard capsule blister pack capsule (325479)