lumateperone deuterated (ITI-1284 ODT-SL) / J&J - LARVOL DELTA

ITI-1284-301: Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=705 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | Trial completion date: Mar 2027 ➔ Oct 2027

Trial completion date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD) (clinicaltrials.gov) - P3 | N=900 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc.

Monotherapy • New P3 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects (clinicaltrials.gov) - P1 | N=58 | Completed | Sponsor: Intra-Cellular Therapies, Inc. | Recruiting ➔ Completed | N=42 ➔ 58

Enrollment change • Trial completion

Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=570 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | Trial completion date: Oct 2027 ➔ Jul 2028

Monotherapy • Trial completion date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=570 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | Trial completion date: Jun 2027 ➔ Oct 2027 | Trial primary completion date: Jun 2027 ➔ Oct 2027

Monotherapy • Trial completion date • Trial primary completion date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | Trial completion date: Jul 2026 ➔ Oct 2026

Trial completion date

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease (clinicaltrials.gov) - P2 | N=370 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | Trial completion date: Oct 2027 ➔ Dec 2028 | Trial primary completion date: Sep 2027 ➔ Sep 2028

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Psychiatry

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | N=30 ➔ 42 | Trial completion date: Sep 2025 ➔ Jul 2026 | Trial primary completion date: Sep 2025 ➔ Jul 2026

Enrollment change • Trial completion date • Trial primary completion date

A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Intra-Cellular Therapies, Inc. | Not yet recruiting ➔ Completed

Trial completion

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | N=12 ➔ 30 | Trial completion date: Mar 2025 ➔ Sep 2025 | Trial primary completion date: Mar 2025 ➔ Sep 2025

Enrollment change • Trial completion date • Trial primary completion date

A Mass Balance Study Following Subcutaneous Administration of [14C]-ITI-1284 to Healthy Male Subjects (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Intra-Cellular Therapies, Inc.

New P1 trial

ITI-1284-301: Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=705 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | Trial completion date: Jan 2027 ➔ Jun 2027 | Trial primary completion date: Dec 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=570 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc.

Monotherapy • New P2 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

ITI-1284-101: A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc.

New P2 trial • Alzheimer's Disease • CNS Disorders • Dementia

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease (clinicaltrials.gov) - P2 | N=370 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc.

New P2 trial • Alzheimer's Disease • CNS Disorders • Psychiatry

Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder (clinicaltrials.gov) - P2 | N=705 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc.

New P2 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Intra-Cellular Therapies, Inc.

New P1 trial

Intra-Cellular Therapies Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - “ITI-1284-ODT-SL program: In 2023, we plan to begin Phase 2 programs in agitation in patients with Alzheimer’s disease (AD), generalized anxiety disorder, and psychosis in patients with AD….Lenrispodun (ITI-214) is our lead PDE1 inhibitor compound….We expect to commence clinical conduct in a Phase 2 trial in Parkinson’s disease later this month….ITI-333 program: ITI-333, a 5-HT2A receptor antagonist and μ-opioid receptor partial agonist, provides potential utility in the treatment of opioid use disorder, pain and mood disorders. A multiple ascending dose study in healthy volunteers evaluating pharmacokinetics (PK), safety and tolerability commenced clinical conduct in the first quarter of 2023. ”

New P1 trial • New P2 trial • Alzheimer's Disease • CNS Disorders • Pain • Parkinson's Disease

Intra-Cellular Therapies Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - “Net product sales of CAPLYTA were $87.4 million for the fourth quarter of 2022, compared to $25.5 million for the same period in 2021, representing a year-over-year increase of 243% and a 22% increase over the third quarter of 2022….Research and development (R&D) expenses for the fourth quarter of 2022 were $33.9 million, compared to $29.5 million for the fourth quarter of 2021. This increase is primarily due to higher lumateperone and non-lumateperone project costs, including the ITI-1284, ITI-214, and ITI-333 programs.”

Commercial • Sales • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Pain • Parkinson's Disease

Intra-Cellular Therapies Reports First Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - “ITI-1284-ODT-SL program: ITI-1284 ODT-SL Phase 1 studies are either ongoing or planned, including food effect and brain-imaging studies. We expect to commence clinical conduct in our agitation in patients with probable Alzheimer’s disease program in 2022, followed by additional studies in dementia-related psychosis and certain depressive disorders in the elderly.”

New trial • Alzheimer's Disease • CNS Disorders • Dementia

Intra-Cellular Therapies Reports Third Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - “Lumateperone: Study 403 is ongoing and is evaluating lumateperone 42mg in patients with MDD and in patients with bipolar depression...We expect to complete this study in the second half of 2022; Study ITI-007-025, a Phase 1 single ascending dose study of LLAI, is ongoing. We expect to complete this study later this year….ITI-1284 program: We have initiated our program for the development of ITI-1284-ODT-SL for the treatment of agitation in patients with probable Alzheimer’s disease. Clinical conduct in this program is expected to commence early in 2022. Studies in dementia-related psychosis and certain depressive disorders in the elderly are planned for the first half of 2022. Phosphodiesterase type I inhibitor (PDE1) program: Our Phase 2 clinical program evaluating lenrispodun (ITI-214) in Parkinson’s disease has been initiated, and we expect to commence patient enrollment in the first half of 2022.”

New P2 trial • New trial • Trial completion date • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Parkinson's Disease • Schizophrenia

Intra-Cellular Therapies Reports Second Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - “ITI-1284 program: We plan to initiate our program for the development of ITI-1284-ODT-SL for the treatment of behavioral disturbances in dementia in the second half of 2021, and plan additional studies in dementia-related psychosis and certain depressive disorders in the elderly in 2022.”

New trial • Alzheimer's Disease • CNS Disorders • Dementia • Depression • Major Depressive Disorder