Two medicines, side by side
Milsaperidone vs iloperidone
Milsaperidone and iloperidone are both labeled for bipolar disorder and schizophrenia. Drugs@FDA records approvals of milsaperidone since 2026 and of iloperidone since 2009.
Check it at the source: the milsaperidone FDA label on DailyMed (effective February 27, 2026); the iloperidone FDA label on DailyMed (effective May 6, 2026).
Highlights of the milsaperidone record
Milsaperidone (Bysanti) · label of February 27, 2026
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. BYSANTI is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning.
Used for
From the label: indicationsBYSANTI ™ is indicated for the: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2) ]. BYSANTI is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 , 14.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
On the market
- Earliest approval on file
- February 20, 2026
- Generic labelers
- none listed
- Pharmacy cost
- Not in the survey
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Highlights of the iloperidone record
Iloperidone (Fanapt) · label of May 6, 2026
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. FANAPT is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning.
Used for
From the label: indicationsFANAPT ® is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ]. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2) ]. FANAPT is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 , 14.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
On the market
- Earliest approval on file
- May 6, 2009
- Generic labelers
- 1 labeler
- Pharmacy cost
- $60.01 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Milsaperidone label of February 27, 2026, Iloperidone label of May 6, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do milsaperidone and iloperidone differ on the record?
How each works, in its label's words: Milsaperidone, “The mechanism of action of milsaperidone in the treatment of schizophrenia in adults and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults is unknown.”; Iloperidone, “The mechanism of action of iloperidone in schizophrenia and bipolar I disorder is unknown.”
Both labels carry a boxed warning; the records quote them.
Generics: milsaperidone none approved; iloperidone since 2016 (Drugs@FDA).
| Milsaperidone | Iloperidone | |
|---|---|---|
| Labeled for | Schizophrenia, Bipolar disorder | Schizophrenia, Bipolar disorder |
| Pharmacologic class | n/a | Atypical Antipsychotic |
| How it works (label) | The mechanism of action of milsaperidone in the treatment of schizophrenia in adults and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults is unknown. | The mechanism of action of iloperidone in schizophrenia and bipolar I disorder is unknown. However, the efficacy of iloperidone could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5-HT 2 ) antagonism. |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | February 20, 2026 | May 6, 2009 |
| First generic approved | none | November 28, 2016 |
| Generic labelers (NDC) | none listed | 1 labeler |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | n/a | $60.01 per tablet (Fanapt 12 mg tablet) |
| 12-month price change | n/a | +4% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | n/a | 1,470 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Milsaperidone label, drug interactionsStrong CYP2D6 inhibitors increased exposure of milsaperidone and iloperidone [see Clinical Pharmacology (12.3, 12.5) ], which may increase the risk of BYSANTI-associated adverse reactions.
Milsaperidone label, warnings and precautionsIn a QTc study, the use of iloperidone (iloperidone and milsaperidone rapidly interconvert in vivo) was associated with QTc interval prolongation, especially with concomitant use of a CYP2D6 inhibitor or a CYP3A4 inhibitor.
Source: FDA drug labels via openFDA
What next?
- Alternatives to milsaperidone
- every medicine labeled for the same conditions