# US 10,441,580 B2 · Iloperidone for the treatment of schizophrenia > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,441,580 B2 - Document ID: US10441580B2 - Status: Granted - Kind: B2 - Application number: 15/549,820 - Filed: 2016-02-17 - Published: 2018-01-25 - Granted: 2019-10-15 - Earliest claimed: 2015-02-17 - Assignees: Vanda Pharmaceuticals Inc. - Applicants: Vanda Pharmaceuticals, Inc. - Inventors: Mihael H. Polymeropoulos; Curt D. Wolfgang - Web page: https://patentgrep.com/patent/US10441580B2 ## CPC - A61K 31/454: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone - A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Aspects of the invention relate generally to the treatment of schizophrenia in an individual and, more specifically, to the treatment of an individual with iloperidone, an iloperidone metabolite, or a pharmaceutically-acceptable salt thereof. In one embodiment, the invention provides a method of preventing schizophrenic relapse in an individual diagnosed with schizophrenia, the method comprising: administering to the individual iloperidone, an iloperidone metabolite, or a pharmaceutically-acceptable salt thereof at a daily dose between about 12 mg and about 16 mg following a period in which the individual's schizophrenia was stabilized. ## Claims ### Claim 1 A method of treating schizophrenia or a symptom of schizophrenia in an individual, the method comprising: administering to the individual a titrated first daily dose of 16-24 mg/day of iloperidone or a pharmaceutically-acceptable salt thereof during an acute treatment phase, wherein the acute treatment phase follows an initial titration of iloperidone, followed by administering to the individual a second daily dose that is smaller than the titrated first daily dose and is 12-16 mg/day of iloperidone or a pharmaceutically-acceptable salt thereof during a maintenance treatment phase, following completion of the acute treatment phase. ### Claim 2 (depends on 1) The method of claim 1, wherein the titrated first daily dose is 8-12 mg of iloperidone administered orally twice daily, and the second daily dose is 6-8 mg of iloperidone administered orally twice daily. ### Claim 3 (depends on 1) The method of claim 1, wherein the second daily dose is 75% of the first daily dose. ### Claim 4 (depends on 1) The method of claim 1, wherein the titrated first daily dose is 16 mg and the second daily dose is 12 mg. ### Claim 5 (depends on 1) The method of claim 1, wherein the titrated first daily dose is 12 mg and the second daily dose is 8 mg. ### Claim 6 (depends on 1) The method of claim 1, wherein the second daily dose is 50% of the first daily dose. ### Claim 7 (depends on 6) The method of claim 6, wherein the titrated first daily dose is 24 mg and the second daily dose is 12 mg. ### Claim 8 (depends on 6) The method of claim 6, wherein the titrated first daily dose is 16 mg and the second daily dose is 8 mg. ### Claim 9 (depends on 6) The method of claim 6, wherein the titrated first daily dose is 12 mg and the second daily dose is 6 mg. ### Claim 10 (depends on 1) The method of claim 1, wherein the second daily dose is between 12 mg and 16 mg. ### Claim 11 (depends on 10) The method of claim 10, wherein the second daily dose is between 12 mg and 14 mg. ### Claim 12 A method of continuing the treatment of schizophrenia in an individual who has been receiving a titrated first daily dose of 16-24 mg/day of iloperidone or a pharmaceutically acceptable salt thereof during an acute treatment phase of the schizophrenia, the method comprising: administering a second daily dose of 12-16 mg/day of iloperidone or the pharmaceutically acceptable salt thereof that is reduced relative to the first daily dose during a subsequent maintenance treatment phase following completion of the acute treatment phase. ### Claim 13 (depends on 12) The method of claim 12, wherein the titrated first daily dose of iloperidone or the pharmaceutically acceptable salt thereof is 8-12 mg administered twice daily, and the second daily dose of iloperidone or the pharmaceutically acceptable salt thereof is 6-8 mg administered twice daily. ### Claim 14 (depends on 12) The method of claim 12, wherein the second daily dose is 75% of the first daily dose. ### Claim 15 (depends on 14) The method of claim 14, wherein the first daily dose is 16 mg and the second daily dose is 12 mg/day. ### Claim 16 (depends on 14) The method of claim 14, wherein the first daily dose is 20 mg and the second daily dose is 15 mg/day. ### Claim 17 (depends on 12) The method of claim 12, wherein the first daily dose is 24 mg and the second daily dose is 16 mg. ### Claim 18 (depends on 12) The method of claim 12, wherein the second daily dose is 50% of the first daily dose. ### Claim 19 (depends on 18) The method of claim 18, wherein the first daily dose is 24 mg and the second daily dose is 12 mg/day. ### Claim 20 (depends on 12) The method of claim 12, wherein the second daily dose is between 12 mg and 14 mg/day.