COMPANY

Ensysce Biosciences

HQ: La Jolla, CA source · ensysce.com ↗ · West Coast

Clinical Phase 3

Location: La Jolla, CA · source · Oct 13, 2026

Profile checked Oct 10, 2026

Keywords: Recreational Drug Use Acute Postoperative Pain Acute Pain PF614

$83.0MRaised (2 yrs)9Trials (company is sponsor)

Funding and NIH signals

NIH award NIH awarded $5.28M (NIH grant 5U01DA059791-03, continuation, notice Jul 14, 2026). NIH RePORTER 5U01DA059791-03 (Jul 14, 2026)
Evidence (1 event)
- Jul 14, 2026 · NIH RePORTER 5U01DA059791-03
  Organization: ENSYSCE BIOSCIENCES, INC.; City/State: LA JOLLA, CA; Project number: 5U01DA059791-03; Activity code: U01; Fiscal year: 2026; Award notice date: 2026-07-14; FY total cost (award amount): 5279389; Administering IC: National Institute on Drug Abuse; Project title: PF614-MPAR: clinical development of opioid with oral overdose protection; Organization type: Domestic For-Profits

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

Timeline

Aug 6, 2026 Raise Private equity round — Convertible note financing: $77M (up to, as announced), announced Aug 6, 2026. Source: SEC filing. source ↗
Jul 14, 2026 Grant Government grant — NIH U01: $5.28M (annual award, as published), announced Jul 14, 2026. Agency: NIH/NIDA. Source: government award database. source ↗
Apr 7, 2026 Raise Private placement: $2M (total, as published), announced Apr 7, 2026. Source: SEC filing. source ↗
Dec 9, 2025 Trial start Phase 3: PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301) source ↗
Nov 17, 2025 Raise Private placement: $4M (total, as published), announced Nov 17, 2025. Source: SEC filing. source ↗
Jun 11, 2025 Grant Government grant — NIH U01: $5.29M (annual award, as published), announced Jun 11, 2025. Agency: NIH/NIDA. Source: government award database. source ↗
Nov 24, 2024 Trial start Phase 1: Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) source ↗
Oct 5, 2023 Trial start Phase 2: Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201) source ↗
Oct 5, 2022 Trial start Phase 1: A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104) source ↗
Jun 10, 2022 Trial start Phase 1: A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103) source ↗
Dec 1, 2021 Trial start Phase 1: Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101) source ↗
Sep 8, 2021 Trial start Phase 1: Evaluation of Oral PF614 Relative to OxyContin (PF614-102) source ↗
Sep 21, 2020 Trial start Phase 1: Oral Nafamostat in Healthy Volunteers (NAF-101) source ↗
Nov 16, 2016 Trial start Phase 1: Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101) source ↗

Upcoming milestones

Dec 22, 2026 (ESTIMATED) · Phase 1 · Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) · NCT06500793

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Raised: $83.0M. Last 2 years.

Aug 6, 2026 Private equity round — Convertible note financing: $77M (up to, as announced), announced Aug 6, 2026. Source: SEC filing. source ↗
Apr 7, 2026 Private placement: $2M (total, as published), announced Apr 7, 2026. Source: SEC filing. source ↗
Nov 17, 2025 Private placement: $4M (total, as published), announced Nov 17, 2025. Source: SEC filing. source ↗
Jul 14, 2026 Government grant — NIH U01: $5.28M (annual award, as published), announced Jul 14, 2026. Agency: NIH/NIDA. Source: government award database. source ↗
Jun 11, 2025 Government grant — NIH U01: $5.29M (annual award, as published), announced Jun 11, 2025. Agency: NIH/NIDA. Source: government award database. source ↗

Clinical trials (lead sponsor) 9

Record	Title	Phase	Status	Start	Primary completion
NCT06500793	Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102)	Phase 1	Recruiting	Nov 24, 2024	Dec 22, 2026 (estimated)
NCT06602271	PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)	Phase 3	Recruiting	Dec 9, 2025	2026-08 (estimated)
NCT06629402	Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)	Phase 2	Completed	Oct 5, 2023	Nov 14, 2023 (actual)
NCT02454712	Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)	Phase 1	Completed	Nov 16, 2016	Jan 18, 2018 (actual)
NCT05567354	A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103)	Phase 1	Completed	Jun 10, 2022	Aug 31, 2022 (actual)
NCT04406415	Oral Nafamostat in Healthy Volunteers (NAF-101)	Phase 1	Completed	Sep 21, 2020	Nov 11, 2020 (actual)
NCT05571345	A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104)	Phase 1	Completed	Oct 5, 2022	Dec 23, 2022 (actual)
NCT05090280	Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)	Phase 1	Completed	Dec 1, 2021	Apr 26, 2023 (actual)
NCT05043766	Evaluation of Oral PF614 Relative to OxyContin (PF614-102)	Phase 1	Completed	Sep 8, 2021	Mar 21, 2022 (actual)