COMPANY

Akyso Therapeutics

HQ: Salisbury, MD source · akyso.com ↗ · Mid-Atlantic

Clinical Phase 1

Location: Salisbury, MD · source · Oct 14, 2026

Profile checked Oct 10, 2026

Keywords: Opioid Use Disorder

2Trials (company is sponsor)7NIH grants

Funding and NIH signals

NIH award NIH awarded $2.93M (NIH grant 5UG3DA062511-02, continuation, notice Aug 4, 2026); 2 NIH awards totaling $5.65M in the last 12 months. NIH RePORTER 5UG3DA062511-02 (Aug 4, 2026)
Evidence (2 events)
- Aug 4, 2026 · NIH RePORTER 5UG3DA062511-02
  Organization: AKYSO THERAPEUTICS, LLC; City/State: SALISBURY, MD; Project number: 5UG3DA062511-02; Activity code: UG3; Fiscal year: 2026; Award notice date: 2026-08-04; FY total cost (award amount): 2932500; Administering IC: National Institute on Drug Abuse; Project title: Development of a bioabsorbable, subcutaneous, extended-release buprenorphine implant for opioid use disorder; Organization type: Domestic For-Profits
- Jun 11, 2026 · NIH RePORTER 5UH3DA048338-05
  Organization: AKYSO THERAPEUTICS, LLC; City/State: SALISBURY, MD; Project number: 5UH3DA048338-05; Activity code: UH3; Fiscal year: 2026; Award notice date: 2026-06-11; FY total cost (award amount): 2715203; Administering IC: National Institute on Drug Abuse; Project title: A Long-Acting Bioabsorbable Naltrexone Subcutaneous Implant for Opioid Use Disorder; Organization type: Domestic For-Profits

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

Timeline

Jul 25, 2026 Trial start Phase 1: iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers source ↗
Jun 24, 2024 Trial start Phase 1: Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults source ↗

Upcoming milestones

Oct 1, 2029 (ESTIMATED) · Phase 1 · iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers · NCT07064564

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 2

Record	Title	Phase	Status	Start	Primary completion
NCT07064564	iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers	Phase 1	Active, not recruiting	Jul 25, 2026	Oct 1, 2029 (estimated)
NCT06216132	Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults	Phase 1	Completed	Jun 24, 2024	Apr 18, 2025 (actual)

NIH awards 7

Annual award amounts. Total $18.9M.

Aug 4, 2026 NIH award 5UG3DA062511-02 FY2026: $2,932,500 awarded for that fiscal year; activity UG3 (OTHER_NIH); PI COHEN, STEVEN M; recipient as written: AKYSO THERAPEUTICS, LLC, SALISBURY, MD. Development of a bioabsorbable, s source ↗
Jun 11, 2026 NIH award 5UH3DA048338-05 FY2026: $2,715,203 awarded for that fiscal year; activity UH3 (OTHER_NIH); PI COHEN, STEVEN M; recipient as written: AKYSO THERAPEUTICS, LLC, SALISBURY, MD. A Long-Acting Bioabsorbable Naltr source ↗
Jul 23, 2025 NIH award 1UG3DA062511-01 FY2025: $2,932,500 awarded for that fiscal year; activity UG3 (OTHER_NIH); PI COHEN, STEVEN M; recipient as written: AKYSO THERAPEUTICS, LLC, SALISBURY, MD. Development of a bioabsorbable, s source ↗
Apr 23, 2025 NIH award 5UH3DA048338-04 FY2025: $2,708,703 awarded for that fiscal year; activity UH3 (OTHER_NIH); PI COHEN, STEVEN M; recipient as written: AKYSO THERAPEUTICS, LLC, SALISBURY, MD. A Long-Acting Bioabsorbable Naltr source ↗
May 9, 2024 NIH award 4UH3DA048338-03 FY2024: $1,806,120 awarded for that fiscal year; activity UH3 (OTHER_NIH); PI COHEN, STEVEN M; recipient as written: AKYSO THERAPEUTICS, LLC, SALISBURY, MD. A Long-Acting Bioabsorbable Naltr source ↗
Mar 30, 2020 NIH award 5UG3DA048338-02 FY2020: $2,700,832 awarded for that fiscal year; activity UG3 (OTHER_NIH); PI COHEN, STEVEN M; recipient as written: AKYSO THERAPEUTICS, LLC, SALISBURY, MD. A Long-Acting Bioabsorbable Naltr source ↗
Mar 15, 2019 NIH award 1UG3DA048338-01A1 FY2019: $3,083,969 awarded for that fiscal year; activity UG3 (OTHER_NIH); PI COHEN, STEVEN M; recipient as written: AKYSO THERAPEUTICS, LLC, SALISBURY, MD. A Long-Acting Bioabsorbable Nal source ↗