Alkermes

Alkermes(ALKS)

DUBLIN 4, Ireland
Biotechnology4 H-1B visas (FY2023)

Focus: Small Molecules

Alkermes is a life sciences company focused on Small Molecules.

NeurologyMetabolic DiseasesRespiratoryPsychiatryGastroenterology
Funding Stage
PUBLIC
Open Jobs
0

Products & Portfolio (4)

2 discontinued products not shown

ARISTADA
aripiprazole lauroxil
Peak
INTRAMUSCULAR · SUSPENSION, EXTENDED RELEASE
aripiprazole. Following intramuscular injection, aripiprazole lauroxil is likely converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. The mechanism of action of aripiprazole in schizophrenia is unknown. However, efficacy could be mediated through a combination of partial agonist activity at dopamine D 2 and serotonin 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.
schizophrenia in adults ()schizophrenia
2015
0
ARISTADA INITIO KIT
aripiprazole lauroxil
Peak
INTRAMUSCULAR · SUSPENSION, EXTENDED RELEASE
aripiprazole. Following intramuscular injection, aripiprazole lauroxil is likely converted by enzyme-mediated hydrolysis to N -hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. The mechanism of action of aripiprazole in schizophrenia is unclear. However, efficacy could be mediated through a combination of partial agonist activity at dopamine D 2 and serotonin 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.
schizophrenia
2018
0
LYBALVI
olanzapine and samidorphan l-malate
Peak
ORAL · TABLET
unclear; however, its efficacy in the treatment of schizophrenia or bipolar I disorder could be mediated through a combination of dopamine and serotonin type 2 (5HT 2 ) antagonism. The mechanism of action of samidorphan could be mediated through opioid receptor antagonism.
Schizophrenia
2021
0
VIVITROL
naltrexone
Peak
INTRAMUSCULAR · FOR SUSPENSION, EXTENDED RELEASE
2006
8

Pipeline & Clinical Trials

ALK21-025: Vivitrol's Cost and Treatment Outcomes Registry
Opioid Dependence
N/A
Clinical Trials (1)
NCT01422837ALK21-025: Vivitrol's Cost and Treatment Outcomes Registry
N/A
ERPs with electroencephalography
Opioid Use Disorder
N/A
Clinical Trials (1)
NCT05495984Neuroplasticity in Maternal Opioid Use Disorder (OUD)
N/A
Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)
Schizophrenia
N/A
Clinical Trials (1)
NCT03919994Observational Study of Long Acting Injectable Medications (LAIs) in Schizophrenia (OASIS)
N/A
Event-Related Potentials
Schizophrenia
N/A
National Pregnancy Registry for Psychiatric Medications
Pregnant Women
N/A
Phase 1
Clinical Trials (1)
NCT02545439A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers
Phase 1
Phase 1
Clinical Trials (1)
NCT00002316The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis
Phase 1
Aripiprazole Lauroxil
Schizophrenia
Phase 1
Clinical Trials (1)
NCT02636842A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
Phase 1
Clinical Trials (1)
NCT05547100Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan
Phase 1
ALKS 9072, Low dose
Schizophrenia
Phase 1
Clinical Trials (1)
NCT01493726A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
Phase 1
RDC-0313 + Buprenorphine
Substance-Related Disorders
Phase 1
Clinical Trials (1)
NCT01046539Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults
Phase 1
Itraconazole
Pharmacokinetics
Phase 1
Clinical Trials (1)
NCT02272764A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers
Phase 1
Ketamine
Healthy
Phase 1
Moxifloxacin
Healthy
Phase 1
Clinical Trials (1)
NCT02479308A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
Phase 1
Phase 1
Clinical Trials (1)
NCT02452801Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic Function
Phase 1
Phase 1
Clinical Trials (1)
NCT02508506Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function
Phase 1
Clinical Trials (1)
NCT05019105Phase 1 ALKS 1140 in Healthy Adults
Phase 1
Phase 1
Clinical Trials (1)
NCT02068105A Study of ALKS 5461 in Healthy Volunteers
Phase 1
[11C]-UCB-J
Healthy
Phase 1
Clinical Trials (1)
NCT03577262A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic Density
Phase 1
ALKS 5461
Healthy
Phase 1
Clinical Trials (1)
NCT02521857A Water Consumption Study of ALKS 5461 in Healthy Volunteers
Phase 1
ALKS 33-BUP
Cocaine Abuse
Phase 1
Clinical Trials (1)
NCT01366001ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine
Phase 1
ALKS 5461
Healthy
Phase 1
Clinical Trials (1)
NCT02413281A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid Users
Phase 1
Phase 1
Clinical Trials (1)
NCT02922426An Insulin Sensitivity Study in Healthy Subjects
Phase 1
RDN-929 oral capsule
Healthy
Phase 1
Clinical Trials (1)
NCT03963973A 28 Day Parallel Group Study to Assess the Effects of RDN-929
Phase 1
Samidorphan IV
Healthy
Phase 1
Clinical Trials (1)
NCT02504463A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male Volunteers
Phase 1
Phase 1
Clinical Trials (1)
NCT04987658Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder
Phase 1
Phase 1
Clinical Trials (1)
NCT00802035ALK29-002: A Study of Baclofen Formulations in Healthy Adults
Phase 1
ALKS 3831
Schizophrenia
Phase 1
Clinical Trials (1)
NCT02804568A Phase 1 Safety Study in Adults With Schizophrenia
Phase 1
Phase 1
Clinical Trials (1)
NCT00800319ALK33-001: A Study of RDC-0313 Administered to Healthy Adults
Phase 1
Phase 1
Clinical Trials (1)
NCT02218021A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users
Phase 1
Aripiprazole Lauroxil
Schizophrenia
Phase 1
Clinical Trials (1)
NCT02320032An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
Phase 1
RDN-929
Healthy
Phase 1
Clinical Trials (1)
NCT03668314Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects
Phase 1
trospium chloride inhalation powder
Chronic Obstructive Pulmonary Disease
Phase 1/2
Clinical Trials (1)
NCT00465959Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
Phase 1/2
Phase 1/2
Clinical Trials (1)
NCT01381107ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD
Phase 1/2
Clinical Trials (1)
NCT01382797ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
Phase 2
Medisorb naltrexone 75 mg
Opiate Dependence
Phase 2
Clinical Trials (1)
NCT01218984ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
Phase 2
Phase 2
Clinical Trials (1)
NCT00945763Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
Phase 2
Phase 2
Clinical Trials (1)
NCT00777062VIVITROL as a Treatment for Cocaine and Alcohol Dependence
Phase 2
Clinical Trials (1)
NCT01449565Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)
Phase 2
Clinical Trials (1)
NCT00801684ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD
Phase 2
Samidorphan
Schizophrenia
Phase 2
Clinical Trials (1)
NCT01903837A Study of ALKS 3831 in Adults With Schizophrenia
Phase 2
Phase 2
Clinical Trials (1)
NCT06843590A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
Phase 2
ALKS 37
OIC
Phase 2
Clinical Trials (1)
NCT01418092ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)
Phase 2
Phase 2
Clinical Trials (1)
NCT01084161Study to Evaluate the Efficacy, Safety and Tolerability of N1539
Phase 2
Samidorphan + olanzapine
Schizophrenia
Phase 2
Clinical Trials (1)
NCT02161718A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
Phase 2
Clinical Trials (1)
NCT01100151ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)
Phase 2
Phase 2
Clinical Trials (1)
NCT01098435ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating Disorder
Phase 2
Phase 2
Clinical Trials (1)
NCT00981617ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence
Phase 2
Phase 2
Clinical Trials (1)
NCT06358950A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
Phase 2

Open Jobs (0)

No open positions listed yet. Check their careers page directly.

Interview Prep Quick Facts
Portfolio: 6 approved products, 46 clinical trials
Top TAs: Neurology, Psychiatry
H-1B (2023): 4 approvals
SEC Filings: 2 available
Portfolio Health
Peak4 (67%)
Post-LOE2 (33%)
6 total products
Therapeutic Area Focus
Neurology
3 marketed
Psychiatry
1 marketed
Marketed
Pipeline

Financials (FY2025)

Revenue
$1.7B50%
R&D Spend
$271M(16%)1%
Net Income
$356M
Cash
$457M

Visa Sponsorship

Sponsors Work Visas
H-1B Petitions (FY2023)
4
Approved
0
Denied
100%
Rate

Source: USCIS H-1B Employer Data Hub