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Alkermes plc. (ALKS)

Alkermes plc, a biopharmaceutical company, engages in the research, development, and commercialization of pharmaceutical products to address unmet medical needs of patients in therapeutic areas in the United States, Ireland, and internationally. The company has a portfolio of proprietary commercial products for the treatment of opioid dependence, alcohol dependence, schizophrenia, bipolar I, and a pipeline of clinical and preclinical product candidates in development for neurological disorders. Its marketed products include ARISTADA, an intramuscular injectable suspension for the treatment of schizophrenia; ARISTADA INITIO for the treatment of schizophrenia in adults; VIVITROL for the treatment of alcohol and prevention of opioid dependence; LYBALVI, an oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and bipolar I disorder; and LUMRYZ, an extended-release oral suspension product for the treatment of cataplexy or EDS in pediatric patients. The company also offers proprietary technology platforms to third parties to enable them to develop, commercialize, and manufacture products. It has collaboration agreements primarily with Janssen Pharmaceutica N.V., Janssen Pharmaceutica Inc, and Janssen Pharmaceutica International. Alkermes plc was founded in 1987 and is headquartered in Dublin, Ireland.

Sector: Pharmaceutical Preparations

Industry: Drug Manufacturers - Specialty & Generic

Alkermes plc logo

Alkermes plc

NASDAQ:ALKSHealthcare
-0.07%$45.34
AH$45.34+0.00%vs close
Mkt Cap$7.61B
Float165.08M
O/S167.76M
Vol
$ Vol
RVOL
Inst Own-
SI11.5%
Earnings
Dilution
Alkermes plc logoNASDAQ:ALKS$45.34-0.07%
Phase Distribution
83 lead-sponsored trials·9 active·68 completed
Early Phase 11
Phase 124
Phase 1/21
Phase 217
Phase 2/31
Phase 333
Phase 43
Not applicable3
(35 more as collaborator)
Status Overview
Recruiting8
Active, not recruiting1
Completed68
Stopped5
Expanded access1

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Completed

    ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults

    VIVITROL 380 mg, Placebo

    Alcohol Dependence

    Enrollment
    31
    Start
    Jul 2007
    Primary Completion
    Jun 2009
    Completion
    Oct 2009
    NCT00511836
  • Phase 4
    Completed

    A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration

    VIVITROL 380mg

    Opioid Dependence

    Enrollment
    27
    Start
    Jan 2011
    Primary Completion
    May 2014
    Completion
    May 2014
    NCT01453374
  • Phase 4
    Completed

    A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia

    Aripiprazole Lauroxil

    Schizophrenia

    Enrollment
    51
    Start
    Dec 2015
    Primary Completion
    Jul 2017
    Completion
    Jul 2017
    NCT02634320
  • Phase 3
    Completed

    ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults

    Medisorb naltrexone 380 mg, Medisorb naltrexone 190 mg

    Alcoholism

    Enrollment
    108
    Start
    Oct 2003
    Primary Completion
    Jan 2007
    Completion
    Jan 2007
    NCT00156923
  • Phase 3
    Terminated

    ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])

    Medisorb naltrexone 380 mg, Oral naltrexone to Medisorb naltrexone 380 mg

    Alcoholism, Opiate Dependence

    Enrollment
    108
    Start
    Aug 2004
    Primary Completion
    Jan 2007
    Completion
    Jan 2007
    NCT00156936
  • Phase 3
    Completed

    ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence

    VIVITROL 380 mg, Placebo for VIVITROL 380 mg

    Alcohol Dependence

    Enrollment
    300
    Start
    Jul 2007
    Primary Completion
    Jan 2011
    Completion
    Mar 2011
    NCT00501631
  • Phase 3
    Completed

    ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence

    VIVITROL® 380 mg, Placebo

    Opiate Dependence

    Enrollment
    250
    Start
    Jun 2008
    Primary Completion
    Oct 2009
    Completion
    Nov 2010
    NCT00678418
  • Phase 3
    Completed

    ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals

    Medisorb naltrexone 380 mg

    Opiate Dependence

    Enrollment
    38
    Start
    Mar 2009
    Primary Completion
    May 2012
    Completion
    May 2012
    NCT00834080
  • Phase 3
    Completed

    ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults

    Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg

    Alcoholism

    Enrollment
    624
    Start
    Feb 2002
    Primary Completion
    Sep 2003
    Completion
    Sep 2003
    NCT01218958
  • Phase 3
    Completed

    ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)

    Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg

    Alcohol Dependence

    Enrollment
    332
    Start
    Aug 2002
    Primary Completion
    Sep 2004
    Completion
    Sep 2004
    NCT01218971
  • Phase 3
    Completed

    ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)

    Medisorb naltrexone 380 mg, Oral naltrexone 50 mg

    Alcoholism

    Enrollment
    436
    Start
    Aug 2003
    Primary Completion
    Mar 2005
    Completion
    Mar 2005
    NCT01218997
  • Phase 3
    Terminated

    Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery

    N1539, N1539

    Laparoscopic Surgery

    Enrollment
    50
    Start
    Oct 2011
    Primary Completion
    Mar 2012
    Completion
    Mar 2012
    NCT01436032
  • Phase 3
    Completed

    A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia

    ALKS 9072, Placebo

    Schizophrenia

    Enrollment
    623
    Start
    Dec 2011
    Primary Completion
    Jan 2014
    Completion
    Mar 2014
    NCT01469039
  • Phase 3
    Completed

    A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

    ALKS 9072, Low, ALKS 9072, High

    Schizophrenia

    Enrollment
    478
    Start
    Jun 2012
    Primary Completion
    Apr 2015
    Completion
    Apr 2015
    NCT01626456
  • Phase 3
    Completed

    An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

    ALKS 9072, Low Dose, ALKS 9072, High Dose

    Schizophrenia

    Enrollment
    291
    Start
    Jul 2013
    Primary Completion
    Jun 2016
    Completion
    Jun 2016
    NCT01895452
  • Phase 3
    Completed

    A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)

    ALKS 5461

    Major Depressive Disorder

    Enrollment
    66
    Start
    Feb 2014
    Primary Completion
    Sep 2014
    Completion
    Sep 2014
    NCT02085135
  • Phase 3
    Completed

    A Long-Term Safety Study of ALKS 5461

    ALKS 5461

    Major Depressive Disorder

    Enrollment
    1,485
    Start
    May 2014
    Primary Completion
    Nov 2017
    Completion
    Nov 2017
    NCT02141399
  • Phase 3
    Completed

    A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

    High Dose ALKS 5461, Low Dose ALKS 5461

    Major Depressive Disorder

    Enrollment
    385
    Start
    May 2014
    Primary Completion
    Dec 2015
    Completion
    Dec 2015
    NCT02158533
  • Phase 3
    Completed

    A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study

    ALKS 5461, Placebo

    Major Depressive Disorder

    Enrollment
    447
    Start
    May 2014
    Primary Completion
    Dec 2015
    Completion
    Dec 2015
    NCT02158546
  • Phase 3
    Completed

    A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

    ALKS 5461, Placebo

    Major Depressive Disorder

    Enrollment
    407
    Start
    Jul 2014
    Primary Completion
    Sep 2016
    Completion
    Oct 2016
    NCT02218008
  • Phase 3
    Completed

    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)

    NTX/BUP, NTX/PBO-B

    Opioid Use Disorder

    Enrollment
    380
    Start
    Aug 2015
    Primary Completion
    Oct 2016
    Completion
    Jan 2017
    NCT02537574
  • Phase 3
    Completed

    A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

    ALK3831, Olanzapine

    Schizophrenia

    Enrollment
    403
    Start
    Dec 2015
    Primary Completion
    May 2017
    Completion
    Jun 2017
    NCT02634346
  • Phase 3
    Completed

    A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

    ALKS 3831

    Schizophrenia

    Enrollment
    281
    Start
    Jan 2016
    Primary Completion
    Jun 2018
    Completion
    Jun 2018
    NCT02669758
  • Phase 3
    Completed

    A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)

    ALKS 3831, Olanzapine

    Schizophrenia

    Enrollment
    561
    Start
    Mar 2016
    Primary Completion
    Nov 2018
    Completion
    Nov 2018
    NCT02694328
  • Phase 3
    Completed

    Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL

    Naltrexone, Placebo

    Opioid Use Disorder

    Enrollment
    101
    Start
    Apr 2016
    Primary Completion
    Nov 2017
    Completion
    Nov 2017
    NCT02696434

1-25 of 83

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