Alkermes plc

ALKS

Held by 11 specialist biotech funds

High Convergence

11 funds opened new positions. Next phase3 readout (OLZ/SAM): Sep 2026. Short interest: 12.2% of float.

BiotechnologyCEO: Richard F. PopsIPO: 1991Website ↗

Alkermes plc, a biopharmaceutical company, researches, develops, and commercializes pharmaceutical products to address unmet medical needs of patients in various therapeutic areas in the United States, Ireland, and internationally. Its marketed products include ARISTADA, an intramuscular injectable suspension for the treatment of schizophrenia; VIVITROL for the treatment of alcohol and prevention of opioid dependence; RISPERDAL CONSTA for the treatment of schizophrenia and bipolar I disorder; INVEGA SUSTENNA for the treatment of schizophrenia and schizoaffective disorder; XEPLION, INVEGA TRINZA, and TREVICTA to treat schizophrenia and schizoaffective; and VUMERITY for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting and active secondary progressive diseases. The company is also developing LYBALVI, an oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and bipolar I disorder; and nemvaleukin alfa, an engineered fusion protein to expand tumor-killing immune cells and to avoid the activation of immunosuppressive cells. 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.

Catalysts

Phase 2Q2 2003Medisorb naltrexone 75 mgOpiate DependenceNCT01218984

Primary: Slope Change From Baseline for Pupil Size (4 weeks (Baseline to Day 28))Enrollment:27/27RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2003Medisorb naltrexone 190 mgAlcoholismNCT01218958

Primary: Percentage of Heavy Drinking Days Over the Treatment Period (Baseline through Week 24 (168 days))Enrollment:624/624RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q3 2004Medisorb naltrexone 190 mgAlcohol DependenceNCT01218971

Primary: Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study (Up to 48 weeks (13 injections), not including base study)Enrollment:332/332NON_RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q1 2005Medisorb naltrexone 380 mgAlcoholismNCT01218997

Primary: Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study (up to 1 year)Enrollment:436/436RANDOMIZED, TREATMENT

Phase 3PositiveQ1 2007Medisorb naltrexone 380 mgAlcoholism, Opiate DependenceNCT00156936

Primary: Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. (Up to 3 years)Enrollment:108/108NON_RANDOMIZED, TREATMENT

Phase 3PositiveQ1 2007Medisorb naltrexone 380 mgAlcoholismNCT00156923

Primary: Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) (Up to 3.5 years of monthly treatment)Enrollment:108/108NON_RANDOMIZED, TREATMENT

Phase 2Q2 2009PlaceboChronic Obstructive Pulmonary Disease (COPD)NCT00801684

Primary: Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L) (15 minutes to 24 hours post-treatment)Enrollment:24/24Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ4 2009VIVITROL® 380 mgOpiate DependenceNCT00678418

Primary: Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A) (20 weeks)Enrollment:250/250Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2009N1539Dental PainNCT00945763

Primary: Pain Intensity Difference at End of Study (0-24 hours)Enrollment:230/230Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q3 2010ALKS33 (RDC-0313) (1 mg)Alcohol DependenceNCT00981617

Primary: Percent of subjects abstinent from heavy drinking (12 Weeks)Enrollment:406/406Sites: 27RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2010RDC-1036 (ALKS 37)Opioid-induced ConstipationNCT01100151

Primary: Change in frequency of spontaneous bowel movement (SBM) from pre-treatment period to treatment period (4 Weeks)Enrollment:Target 60Sites: 11RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ1 2011VIVITROL 380 mgAlcohol DependenceNCT00501631

Primary: Cumulative Percentage of Participants by Heavy Drinking Rate (up to 12 weeks)Enrollment:300/300RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q1 2011N1539HysterectomyNCT01084161

Primary: To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours. (at 60 minutes post dose and at 24 hours)Enrollment:486/486Sites: 12RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q2 2011RDC-0313 (ALKS 33)Binge Eating DisorderNCT01098435

Primary: Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE) (6 Weeks)Enrollment:69/69Sites: 6RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2PositiveQ3 2011ALKS 5461Major Depressive DisorderNCT01381107

Primary: The number and percent of subjects with treatment-emergent adverse events following sublingual administration of ALKS 33 and buprenorphine co-formulation (ALKS 5461) (7 days)Enrollment:Target 32Sites: 2RANDOMIZED, TRIPLE

Phase 3NegativeQ1 2012N1539Laparoscopic SurgeryNCT01436032

Primary: Sum of the time-weighted pain intensity differences (SPID) as recorded on the Visual Analog Scale (VAS) from baseline (time 0) to 24 hours following the first dose of study medication (SPID 24) (0 to 24 hours)Enrollment:50/50Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2012ALKS 37Opioid-induced ConstipationNCT01382797

Primary: Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response. (4 weeks)Enrollment:157/157Sites: 20RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q2 2012Medisorb naltrexone 380 mgOpiate DependenceNCT00834080

Primary: Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. (2 years (Baseline to end of study))Enrollment:38/38Sites: 11NA, TREATMENT

Phase 2Q2 2012ALKS 37OICNCT01418092

Primary: Change from baseline in the weekly average of complete spontaneous bowel movements during treatment (Weeks 1 through 4 of treatment)Enrollment:91/91Sites: 13RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2PositiveQ1 2013ALKS 5461Major Depressive DisorderNCT01500200

Primary: Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score (Baseline and 4 weeks for each stage)Enrollment:142/142Sites: 27RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ1 2014ALKS 9072SchizophreniaNCT01469039

Primary: The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score (Data collected from baseline to day 85)Enrollment:623/623Sites: 84RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2014ALKS 5461Major Depressive DisorderNCT02085135

Primary: Number of Subjects With Adverse Events (AEs) (8 weeks)Enrollment:66/66Sites: 9RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2014Samidorphan (Low Dose)SchizophreniaNCT01903837

Primary: Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score (Baseline (Day 8) to Day 92 (end of study Part A))Enrollment:347/347Sites: 61RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q2 2015ALKS 9072, LowSchizophreniaNCT01626456

Primary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) (52 weeks)Enrollment:478/478Sites: 82RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2015High Dose ALKS 5461Major Depressive DisorderNCT02158533

Primary: Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Baseline and 5 weeks for each stage)Enrollment:385/385Sites: 49RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ4 2015ALKS 5461Major Depressive DisorderNCT02158546

Primary: Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Baseline and week 6)Enrollment:447/447Sites: 58RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q2 2016ALKS 9072, Low DoseSchizophreniaNCT01895452

Primary: Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs) (Up to 12 months)Enrollment:291/291Sites: 57RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2016ALKS 5461Major Depressive DisorderNCT02218008

Primary: Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) (Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect)Enrollment:407/407Sites: 44RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2016NTX/BUPOpioid Use DisorderNCT02537574

Primary: Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection (1 week)Enrollment:380/380Sites: 20RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q1 2017Samidorphan + olanzapine (ALKS 3831)Schizophrenia, Alcohol Use DisorderNCT02161718

Primary: Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) (Up to 15 months)Enrollment:300/300Sites: 71RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q2 2017ALK3831SchizophreniaNCT02634346

Primary: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 (4 weeks)Enrollment:403/403Sites: 31RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ4 2017ALKS 5461Major Depressive DisorderNCT02141399

Primary: Incidence of Adverse Events (AEs) (Up to 56 weeks)Enrollment:1,485/1,485Sites: 158NA, TREATMENT

Phase 3Q4 2017NaltrexoneOpioid Use DisorderNCT02696434

Primary: Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8 (8 days)Enrollment:101/101Sites: 9RANDOMIZED, DOUBLE, TREATMENT

Phase 3PositiveQ2 2018ALKS 3831SchizophreniaNCT02669758

Primary: Number of Participants With Adverse Events (AEs) (Up to 52 weeks)Enrollment:281/281Sites: 31NA, TREATMENT

Phase 3PositiveQ4 2018ALKS 3831SchizophreniaNCT02694328

Primary: Percent Change From Baseline in Body Weight at Week 24 (Baseline and Week 24)Enrollment:561/561Sites: 54RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q1 2019Paliperidone PalmitateSchizophreniaNCT03345979

Primary: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 (Baseline and 4 weeks)Enrollment:200/200Sites: 16RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ4 2019ALKS 3831SchizophreniaNCT02873208

Primary: Number of Subjects With Adverse Events (Up to 52 weeks)Enrollment:266/266Sites: 45NA, TREATMENT

Phase 3Q1 2020ALKS 5461Major Depressive DisorderNCT03188185

Primary: Change From Baseline to the End of Treatment (EOT) in the Montgomery Asberg Depression Rating Scale-10 (MADRS-10) Scores (Baseline and 5 weeks for Stage 1, Baseline and 6 weeks for Stage 2)Enrollment:278/278Sites: 35RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3NegativeQ2 2020ALKS 5461Refractory Major Depressive DisorderNCT03610048

Primary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) (Up to 68 weeks)Enrollment:175/175Sites: 34NA, TREATMENT

Phase 3Q4 2021ALKS 3831Schizophrenia, Schizophreniform Disorders, Bipolar I DisorderNCT03187769

Primary: Percent Change From Baseline in Body Weight at Week 12 (Baseline and 12 weeks)Enrollment:426/426Sites: 57RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q3 2023ALKS 3831Schizophrenia, Schizophreniform Disorder, Bipolar I DisorderNCT03201757

Phase 2Q2 2025ALKS 2680Narcolepsy Type 1NCT06358950

Phase 2Q4 2025ALKS 2680Narcolepsy Type 2NCT06555783

Phase 3Q3 2026OLZ/SAMSchizophrenia, Bipolar I DisorderNCT05303064

Phase 2Q4 2026ALKS 2680Idiopathic HypersomniaNCT06843590

Phase 3Q2 2027ALKS 2680 Dose 1Narcolepsy Type 1NCT07455383

Phase 3Q2 2027ALKS 2680 Dose 1Narcolepsy Type 2NCT07502443

Phase 3Q2 2027ALKS 2680 Dose 1Narcolepsy Type 1NCT07540897

Phase 2Q3 2027ALKS 7290Attention Deficit Disorder With Hyperactivity (ADHD)NCT07755410

Phase 3Q3 2027OLZ/SAMBipolar I Disorder, SchizophreniaNCT04987229

Phase 3Q2 2028ALKS 2680, 4mgNarcolepsy Type 1, Narcolepsy Type 2, Idiopathic HypersomniaNCT06767683

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