COMPANY

Oui Therapeutics, Inc.

HQ: New Haven, CT source · ouitherapeutics.com ↗ · New England

Oui Therapeutics, Inc.'s website says: "We have been involved in bringing new classes of FDA regulated products to market (including new mechanisms of action for diseases including schizophrenia)." From company website Source · Oct 13, 2026

Keywords: Post Traumatic Stress Disorder Suicidal Ideation PTSD Attempted Suicide Obesity Binge Eating OTX-601 Digital Therapeutic - Version 1 OTX-601 Digital Therapeutic - Version 2 OTX-601 Digital Therapeutic OTX-003 Comparator app OTX-207 OTX-202 OTX-000 OTX-401 Software Application

Location: New Haven, CT · source · Oct 15, 2026

Profile checked Oct 10, 2026

6Trials (company is sponsor)12NIH grants

Funding and NIH signals

NIH award NIH awarded $967K (SBIR Phase II 4R44MH136888-03, extension, notice Jul 28, 2026). NIH RePORTER 4R44MH136888-03 (Jul 28, 2026)
Evidence (1 event)
- Jul 28, 2026 · NIH RePORTER 4R44MH136888-03
  Organization: OUI THERAPEUTICS, INC; City/State: NEW HAVEN, CT; Project number: 4R44MH136888-03; Activity code: R44; Fiscal year: 2026; Award notice date: 2026-07-28; FY total cost (award amount): 966804; Administering IC: National Institute of Mental Health; Project title: Development and Evaluation of a Novel Digital Therapeutic for Adults with Post-Traumatic Stress Disorder; Organization type: Domestic For-Profits

Job counts as of Oct 18, 2026. All funding and NIH signals

Timeline

Jul 28, 2026 Grant Government grant — SBIR: $966,804 (annual award, as published), announced Jul 28, 2026. Agency: NIH/NIMH. Source: government award database. source ↗
Dec 9, 2025 Trial start Phase 2: Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms source ↗
Oct 23, 2025 Trial start Not phased (device or behavioral study): Pilot Trial of Mobile Technology for Adolescent Suicidality source ↗
Jul 31, 2025 Grant Government grant — STTR: $596,110 (annual award, as published), announced Jul 31, 2025. Agency: NIH/NIMH. Source: government award database. source ↗
Jun 30, 2025 Trial start Phase 1: Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD) source ↗
Jun 10, 2025 Grant Government grant — SBIR: $417,356 (annual award, as published), announced Jun 10, 2025. Agency: NIH/NIMH. Source: government award database. source ↗
2024-09 Trial start Not phased (device or behavioral study): Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity source ↗
Apr 7, 2022 Trial start Phase 2/Phase 3: A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic source ↗
May 12, 2020 Trial start Not phased (device or behavioral study): Feasibility Study of a Software Application for Patients Hospitalized After Suicidal Ideation or Suicide Attempts source ↗

Funding

Last 2 years.

Jul 28, 2026 Government grant — SBIR: $966,804 (annual award, as published), announced Jul 28, 2026. Agency: NIH/NIMH. Source: government award database. source ↗
Jul 31, 2025 Government grant — STTR: $596,110 (annual award, as published), announced Jul 31, 2025. Agency: NIH/NIMH. Source: government award database. source ↗
Jun 10, 2025 Government grant — SBIR: $417,356 (annual award, as published), announced Jun 10, 2025. Agency: NIH/NIMH. Source: government award database. source ↗

Clinical trials (lead sponsor) 6

Record	Title	Phase	Status	Start	Primary completion
NCT06868446	Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)	Phase 1	Completed	Jun 30, 2025	Nov 18, 2025 (actual)
NCT07316088	Determining the Potential for Efficacy of OTX-601 in Reducing PTSD Symptoms	Phase 2	Active, not recruiting	Dec 9, 2025	Jul 31, 2026 (estimated)
NCT06454136	Pilot Trial of Mobile Technology for Adolescent Suicidality	Not phased (device or behavioral study)	Enrolling by invitation	Oct 23, 2025	2026-06 (estimated)
NCT05144685	A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic	Phase 2/Phase 3	Terminated	Apr 7, 2022	Jun 14, 2024 (actual)
NCT06454123	Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity	Not phased (device or behavioral study)	Unknown status (ClinicalTrials.gov)	2024-09	2025-03 (estimated)
NCT04295382	Feasibility Study of a Software Application for Patients Hospitalized After Suicidal Ideation or Suicide Attempts	Not phased (device or behavioral study)	Completed	May 12, 2020	Jul 1, 2021 (actual)

NIH awards 12

Annual award amounts. Total $6.7M.

Jun 5, 2024 NIH award 1R44MH136888-01 FY2024: $440,092 awarded for that fiscal year; activity R44 (SBIR); PI SIMON, PATRICIA; recipient as written: OUI THERAPEUTICS, INC, NEW HAVEN, CT. Development and Evaluation of a Novel Digi source ↗
May 28, 2024 NIH award 3R42MH125691-03S1 FY2024: $125,443 awarded for that fiscal year; activity R42 (STTR); PI SIMON, PATRICIA; recipient as written: OUI THERAPEUTICS, INC, NEW HAVEN, CT. An Efficacy Trial of Mobile Technology f source ↗
Apr 23, 2024 NIH award 6R42MH125691-03 FY2024: $480,049 awarded for that fiscal year; activity R42 (STTR); PI SIMON, PATRICIA; recipient as written: OUI THERAPEUTICS, INC, NEW HAVEN, CT. An Efficacy Trial of Mobile Technology for source ↗
Sep 1, 2023 NIH award 1R41MH134704-01 FY2023: $375,273 awarded for that fiscal year; activity R41 (STTR); PI SIMON, PATRICIA; recipient as written: OUI THERAPEUTICS, INC, NEW HAVEN, CT. A Self-Guided Mobile Intervention for Adul source ↗
Aug 31, 2023 NIH award 5R43MH128431-02 FY2023: $205,926 awarded for that fiscal year; activity R43 (SBIR); PI SIMON, PATRICIA; recipient as written: OUI THERAPEUTICS, INC, NEW HAVEN, CT. A Digital Psychoeducational Social Network source ↗
Aug 28, 2023 NIH award 5R42MH123357-04 FY2023: $795,120 awarded for that fiscal year; activity R42 (STTR); PI SIMON, PATRICIA; recipient as written: OUI THERAPEUTICS, INC, NEW HAVEN, CT. An Efficacy Trial of a Digital Therapeutic source ↗
Mar 16, 2023 NIH award 2R42MH125691-02 FY2023: $766,481 awarded for that fiscal year; activity R42 (STTR); PI SIMON, PATRICIA; recipient as written: OUI THERAPEUTICS, INC, NEW HAVEN, CT. An Efficacy Trial of Mobile Technology for source ↗
Sep 15, 2022 NIH award 1R43MH128431-01A1 FY2022: $453,596 awarded for that fiscal year; activity R43 (SBIR); PI SIMON, PATRICIA; recipient as written: OUI THERAPEUTICS, INC, NEW HAVEN, CT. A Digital Psychoeducational Social Netwo source ↗
Jul 29, 2022 NIH award 5R42MH123357-03 FY2022: $949,997 awarded for that fiscal year; activity R42 (STTR); PI SIMON, PATRICIA; recipient as written: OUI THERAPEUTICS, INC, NEW HAVEN, CT. An Efficacy Trial of a Digital Therapeutic source ↗
Jul 12, 2021 NIH award 2R42MH123357-02 FY2021: $1,249,571 awarded for that fiscal year; activity R42 (STTR); PI SIMON, PATRICIA; recipient as written: OUI THERAPEUTICS, INC, NEW HAVEN, CT. An Efficacy Trial of a Digital Therapeut source ↗
Feb 12, 2021 NIH award 1R43MH125691-01 FY2021: $398,984 awarded for that fiscal year; activity R43 (SBIR); PI FEUERSTEIN, SETH; recipient as written: OUI THERAPEUTICS, INC, NEW HAVEN, CT. Mobile Technology for Reducing and Preven source ↗
Jul 23, 2020 NIH award 1R43MH123357-01 FY2020: $481,035 awarded for that fiscal year; activity R43 (SBIR); PI FEUERSTEIN, SETH; recipient as written: OUI THERAPEUTICS, INC, NEW HAVEN, CT. A Digital Therapeutic to Advance the Deli source ↗