COMPANY

Alkermes, Inc.

Keywords: small molecule Narcolepsy Type 1 Narcolepsy Type 2 Schizophrenia Bipolar I Disorder Major Depressive Disorder Idiopathic Hypersomnia Schizophreniform Disorder Opioid Use Disorder Opiate Dependence Alcoholism Attention Deficit Disorder With Hyperactivity (ADHD) Bipolar 1 Disorder Schizophrenia Disorder Central Nervous System Diseases Alcohol Use Disorder Refractory Major Depressive Disorder Alzheimer Disease Opioid Dependence Alcohol Dependence ALKS 2680 OLZ/SAM ALKS 3831 ALKS 5461 RDN-929 Aripiprazole Lauroxil ALKS 7290 ALKS 1140

Profile checked Oct 10, 2026

82Trials (company is sponsor)15NIH grants

Timeline

Aug 13, 2026 Trial start Phase 3: A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) source ↗
Aug 10, 2026 Trial start Phase 2: A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201) source ↗
Apr 22, 2026 Trial start Phase 3: A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 source ↗
Apr 6, 2026 Trial start Phase 3: A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 source ↗
May 22, 2025 Trial start Phase 2: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia source ↗
Jan 27, 2025 Trial start Phase 2/Phase 3: A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia source ↗
Jul 26, 2024 Trial start Phase 2: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 source ↗
Mar 24, 2024 Trial start Phase 2: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201) source ↗
Sep 14, 2022 Trial start Phase 1: Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan source ↗
Jun 30, 2022 Trial start Phase 3: Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder source ↗
Oct 22, 2021 Trial start Phase 3: Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects source ↗
Oct 13, 2021 Trial start 1: Phase 1 ALKS 1140 in Healthy Adults source ↗
Jul 22, 2021 Trial start 1: Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder source ↗
May 16, 2019 Trial start Phase 1: A 28 Day Parallel Group Study to Assess the Effects of RDN-929 source ↗
Mar 28, 2019 Trial start —: Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS) source ↗
Oct 10, 2018 Trial start Phase 1: Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects source ↗
Aug 9, 2018 Trial start Phase 3: A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD) source ↗
Jul 23, 2018 Trial start Early phase 1: A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density source ↗
Nov 15, 2017 Trial start Phase 3: A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia source ↗
Jun 15, 2017 Trial start Phase 3: Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 source ↗
Jun 12, 2017 Trial start Phase 3: A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD) source ↗
Jun 8, 2017 Trial start Phase 3: Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder source ↗
2016-09 Trial start Phase 1: An Insulin Sensitivity Study in Healthy Subjects source ↗
Aug 7, 2016 Trial start 3: A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia source ↗
2016-04 Trial start Phase 3: Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL source ↗

Showing 25 of 49 dated events.

Upcoming milestones

2026-11 (ESTIMATED) · Phase 2 · A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia · NCT06843590
2027-05 (ESTIMATED) · Phase 3 · A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 · NCT07502443
2027-05 (ESTIMATED) · Phase 3 · A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 · NCT07455383
2027-06 (ESTIMATED) · Phase 3 · A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) · NCT07540897
2027-07 (ESTIMATED) · Phase 2 · A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201) · NCT07755410
2027-09 (ESTIMATED) · Phase 3 · Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects · NCT04987229
2030-06 (ESTIMATED) · Phase 2/Phase 3 · A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia · NCT06767683

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) Showing 50 of 82

Record	Title	Phase	Status	Start	Primary completion
NCT06767683	A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia	Phase 2/Phase 3	Recruiting	Jan 27, 2025	2030-06 (estimated)
NCT07540897	A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)	Phase 3	Recruiting	Aug 13, 2026	2027-06 (estimated)
NCT07755410	A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)	Phase 2	Recruiting	Aug 10, 2026	2027-07 (estimated)
NCT07502443	A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2	Phase 3	Recruiting	Apr 22, 2026	2027-05 (estimated)
NCT07455383	A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1	Phase 3	Recruiting	Apr 6, 2026	2027-05 (estimated)
NCT06843590	A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia	Phase 2	Active, not recruiting	May 22, 2025	2026-11 (estimated)
NCT05303064	Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder	Phase 3	Recruiting	Jun 30, 2022	2026-09 (estimated)
NCT04987229	Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects	Phase 3	Enrolling by invitation	Oct 22, 2021	2027-09 (estimated)
NCT07744113	An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)	Not listed	Available	Not listed	Not listed
NCT06358950	A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)	Phase 2	Completed	Mar 24, 2024	Jun 19, 2025 (actual)
NCT06555783	A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2	Phase 2	Completed	Jul 26, 2024	Nov 11, 2025 (actual)
NCT03201757	Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831	Phase 3	Completed	Jun 15, 2017	Sep 6, 2023 (actual)
NCT04987658	Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder	1	Completed	Jul 22, 2021	Aug 11, 2023 (actual)
NCT05547100	Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan	Phase 1	Completed	Sep 14, 2022	Nov 19, 2022 (actual)
NCT03919994	Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)	Not listed	Completed	Mar 28, 2019	Jan 4, 2023 (actual)
NCT03187769	Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder	Phase 3	Completed	Jun 8, 2017	Dec 1, 2021 (actual)
NCT05019105	Phase 1 ALKS 1140 in Healthy Adults	1	Terminated	Oct 13, 2021	Aug 23, 2022 (actual)
NCT02161718	A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder	Phase 2	Completed	2014-05	Jan 11, 2017 (actual)
NCT01903837	A Study of ALKS 3831 in Adults With Schizophrenia	Phase 2	Completed	2013-06	2014-12 (actual)
NCT02873208	A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia	3	Completed	Aug 7, 2016	Oct 17, 2019 (actual)
NCT03610048	A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)	Phase 3	Terminated	Aug 9, 2018	May 1, 2020 (actual)
NCT03188185	A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)	Phase 3	Completed	Jun 12, 2017	Feb 26, 2020 (actual)
NCT03345979	A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia	Phase 3	Completed	Nov 15, 2017	Mar 12, 2019 (actual)
NCT03668314	Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects	Phase 1	Completed	Oct 10, 2018	Apr 15, 2019 (actual)
NCT03963973	A 28 Day Parallel Group Study to Assess the Effects of RDN-929	Phase 1	Terminated	May 16, 2019	Jan 22, 2020 (actual)
NCT03577262	A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density	Early phase 1	Completed	Jul 23, 2018	Aug 2, 2019 (actual)
NCT02694328	A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)	Phase 3	Completed	Mar 2, 2016	Nov 7, 2018 (actual)
NCT02218008	A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study	Phase 3	Completed	2014-07	2016-09 (actual)
NCT02158533	A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study	Phase 3	Completed	2014-05	2015-12 (actual)
NCT02085135	A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)	Phase 3	Completed	2014-02	2014-09 (actual)
NCT02669758	A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia	Phase 3	Completed	Jan 20, 2016	Jun 29, 2018 (actual)
NCT02158546	A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study	Phase 3	Completed	2014-05	2015-12 (actual)
NCT01500200	A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)	Phase 2	Completed	2011-12	2013-03 (actual)
NCT02537574	Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)	Phase 3	Completed	2015-08	Oct 27, 2016 (actual)
NCT02696434	Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL	Phase 3	Completed	2016-04	2017-11 (actual)
NCT01469039	A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia	Phase 3	Completed	2011-12	2014-01 (actual)
NCT02141399	A Long-Term Safety Study of ALKS 5461	Phase 3	Completed	2014-05	Nov 20, 2017 (actual)
NCT00834080	ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals	Phase 3	Completed	2009-03	2012-05 (actual)
NCT02634320	A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia	Phase 4	Completed	2015-12	Jul 11, 2017 (actual)
NCT01422837	ALK21-025: Vivitrol's Cost and Treatment Outcomes Registry	Not listed	Completed	2011-08	2013-10 (actual)
NCT01626456	A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)	Phase 3	Completed	2012-06	2015-04 (actual)
NCT02320032	An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia	Phase 1	Completed	2014-12	2016-04 (actual)
NCT01493726	A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia	Phase 1	Completed	2011-12	2013-06 (actual)
NCT02634346	A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)	Phase 3	Completed	2015-12	May 25, 2017 (actual)
NCT01895452	An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)	Phase 3	Completed	2013-07	2016-06 (actual)
NCT02922426	An Insulin Sensitivity Study in Healthy Subjects	Phase 1	Completed	2016-09	Jul 20, 2017 (actual)
NCT00511836	ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults	Phase 4	Completed	2007-07	2009-06 (actual)
NCT01218958	ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults	Phase 3	Completed	2002-02	2003-09 (actual)
NCT00156923	ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults	Phase 3	Completed	2003-10	2007-01 (actual)
NCT00678418	ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence	Phase 3	Completed	2008-06	2009-10 (actual)

NIH awards 15

Annual award amounts. Total $4.4M.

Aug 2, 2012 NIH award 5R01DA031000-03 FY2012: $214,588 awarded for that fiscal year; activity R01 (OTHER_NIH); PI TURNCLIFF, RYAN; recipient as written: ALKERMES, INC., WALTHAM, MA. Clinical advancement of RDC-0313-buprenorphine source ↗
Aug 17, 2011 NIH award 5R01DA031000-02 FY2011: $1,037,900 awarded for that fiscal year; activity R01 (OTHER_NIH); PI TURNCLIFF, RYAN; recipient as written: ALKERMES, INC., WALTHAM, MA. Clinical advancement of RDC-0313-buprenorphi source ↗
Sep 30, 2010 NIH award 1R01DA031000-01 FY2010: $1,061,000 awarded for that fiscal year; activity R01 (OTHER_NIH); PI TURNCLIFF, RYAN; recipient as written: ALKERMES, INC., WALTHAM, MA. Clinical advancement of RDC-0313-buprenorphi source ↗
May 25, 2001 NIH award 1R43DA013531-01A1 FY2001: $98,980 awarded for that fiscal year; activity R43 (SBIR); PI BARTUS, RAYMOND T.; recipient as written: ALKERMES, INC., WALTHAM, MA. Novel, sustained-release naltrexone for opiate source ↗
2000 NIH contract (government contract; not a grant and not an investment round) N43AA001002-000 FY2000: $99,193 awarded for that fiscal year; activity N43 (OTHER_NIH); PI BARTUS, RAYMOND; recipient as written: ALKERMES, INC., WALTHAM, MA. SUSTAINED RELEASE NALTREX source ↗
Jun 26, 1998 NIH award 5R44MH054940-03 FY1998: $380,853 awarded for that fiscal year; activity R44 (SBIR); PI MCGRATH, JOHN P; recipient as written: ALKERMES, INC., WALTHAM, MA. GENE THERAPY OF MIDBRAIN DOPAMINE CIRCUITS source ↗
Jun 24, 1997 NIH award 2R44MH054940-02 FY1997: $367,869 awarded for that fiscal year; activity R44 (SBIR); PI MCGRATH, JOHN P; recipient as written: ALKERMES, INC., WALTHAM, MA. GENE THERAPY OF MIDBRAIN DOPAMINE CIRCUITS source ↗
Jul 25, 1995 NIH award 1R43MH054940-01 FY1995: $100,000 awarded for that fiscal year; activity R43 (SBIR); PI MCGRATH, JOHN P; recipient as written: ALKERMES, INC., WALTHAM, MA. GENE THERAPY OF MIDBRAIN DOPAMINE CIRCUITS source ↗
Sep 21, 1993 NIH award 5R44NS029601-03 FY1993: $234,604 awarded for that fiscal year; activity R44 (SBIR); PI FRIDEN, PHILLIP M; recipient as written: ALKERMES, INC., WALTHAM, MA. DELIVERY OF NERVE GROWTH FACTOR TO THE BRAIN source ↗
Sep 11, 1992 NIH award 5R44NS028256-03 FY1992: $249,275 awarded for that fiscal year; activity R44 (SBIR); PI DOCTROW, SUSAN; recipient as written: ALKERMES, INC., WALTHAM, MA. DEVELOPMENT OF AN IN VITRO BLOOD-BRAIN BARRIER source ↗
Aug 31, 1992 NIH award 1R43AI033242-01 FY1992: $49,595 awarded for that fiscal year; activity R43 (SBIR); PI STARZYK, RUTH M; recipient as written: ALKERMES, INC., WALTHAM, MA. ANTIBODIES THAT REVERSIBLY OPEN THE BLOOD-BRAIN BARR source ↗
Aug 28, 1992 NIH award 2R44NS029601-02 FY1992: $183,191 awarded for that fiscal year; activity R44 (SBIR); PI FRIDEN, PHILLIP M; recipient as written: ALKERMES, INC., WALTHAM, MA. DELIVERY OF NERVE GROWTH FACTOR TO THE BRAIN source ↗
Aug 14, 1991 NIH award 2R44NS028256-02 FY1991: $250,670 awarded for that fiscal year; activity R44 (SBIR); PI DOCTROW, SUSAN; recipient as written: ALKERMES, INC., WALTHAM, MA. DEVELOPMENT OF AN IN VITRO BLOOD-BRAIN BARRIER source ↗
Apr 9, 1991 NIH award 1R43NS029601-01 FY1991: $49,200 awarded for that fiscal year; activity R43 (SBIR); PI FRIDEN, PHILLIP M; recipient as written: ALKERMES, INC., WALTHAM, MA. DELIVERY OF NERVE GROWTH FACTOR TO THE BRAIN source ↗
Dec 20, 1989 NIH award 1R43NS028256-01 FY1990: $50,000 awarded for that fiscal year; activity R43 (SBIR); PI DOCTROW, SUSAN; recipient as written: ALKERMES, INC., WALTHAM, MA. DEVELOPMENT OF AN IN VITRO HUMAN BLOOD-BRAIN BARRIER source ↗

Raises and investors new

Form D raises come from the company’s own SEC filing (last 2 years).

InvestorListed in the portfolio of Bain Capital Life Sciences (captured Oct 12, 2026). portfolio page ↗