Iloperidone Vanda Pharmaceuticals (iloperidone)

Region: 🇪🇺 EU
Active substance: iloperidone
Company: Vanda Pharmaceuticals Netherlands B.V.
Status: Refused
Therapeutic area: Schizophrenia; Bipolar Disorder
CHMP opinion: Thu 26 Feb 2026
Application: EMEA/H/C/006561
ATC: N05AX14
Official record: www.ema.europa.eu

Indication

Iloperidone is indicated for: treatment of schizophrenia in adults acute treatment of manic or mixed episodes associated with bipolar I disorder in adults

Regulatory milestones

Fri 12 Jun 2026🇪🇺 EU refusal

Iloperidone Vanda Pharmaceuticals (iloperidone): EU marketing authorisation refused

Vanda Pharmaceuticals Netherlands B.V. · source

Thu 26 Feb 2026🇪🇺 CHMP negative opinion

Iloperidone Vanda Pharmaceuticals (iloperidone): CHMP negative opinion

Vanda Pharmaceuticals Netherlands B.V. · source

Same substance in other markets

🇪🇺 Fanaptum Refused · Vanda Pharmaceuticals Ltd
🇪🇺 Fanaptum Application withdrawn · Vanda Pharmaceuticals Ltd

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.