Alcohol Dependence

16
Pipeline Programs
5
Companies
13
Clinical Trials
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
0
2
0
5
6
Early DiscoveryClinical DevelopmentMarket

On Market (4)

Approved therapies currently available

UP
KEPPRAApproved
levetiracetam
UCB Pharma
oral2003
UP
KEPPRA XRApproved
levetiracetam
UCB Pharma
oral2008
U
LEVETIRACETAMApproved
levetiracetam
Unknown Company
oral2012
U
SPRITAMApproved
levetiracetam
Unknown Company
oral2015

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Alkermes
AlkermesDUBLIN 4, Ireland
7 programs
2
1
2
2
Extended release injectable naltrexonePhase 41 trial
VIVITROL 380 mgPhase 41 trial
Medisorb naltrexone 190 mgPhase 31 trial
VIVITROL 380 mgPhase 31 trial
ALKS33Phase 21 trial
+2 more programs
Active Trials
NCT00802035CompletedEst. Feb 2009
NCT00800319CompletedEst. Jun 2009
NCT00981617CompletedEst. Aug 2010
+4 more trials
UP
UCB PharmaBelgium - Brussels
1 program
1
1
levetiracetamPhase 31 trial
Active Trials
NCT00758277Completed201Est. Dec 2009
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
2 programs
2
Ondansetron + Cognitive Behavioral TherapyPhase 31 trial
Topiramate + Cognitive Behavioral TherapyPhase 31 trial
Active Trials
NCT00382642Completed283Est. Dec 2009
NCT00448825Unknown180Est. Jun 2013
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
ABT-436Phase 22 trials
Active Trials
NCT01613014Completed150Est. Jul 2015
NCT01380704Completed51Est. Sep 2011
Alliance Pharmaceuticals
1 program
1
PT150Phase 11 trial
Active Trials
NCT03548714Completed10Est. Jul 2019

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AlkermesExtended release injectable naltrexone
AlkermesVIVITROL 380 mg
AlkermesVIVITROL 380 mg
UCB Pharmalevetiracetam
Johnson & JohnsonTopiramate + Cognitive Behavioral Therapy
Johnson & JohnsonOndansetron + Cognitive Behavioral Therapy
AlkermesMedisorb naltrexone 190 mg
AbbVieABT-436
AlkermesALKS33
Alliance PharmaceuticalsPT150
AbbVieABT-436
AlkermesRDC-0313
AlkermesBaclofen IR

Clinical Trials (13)

Total enrollment: 875 patients across 13 trials

NCT00620750AlkermesExtended release injectable naltrexone

Extended-release Naltrexone for Alcohol Dependence in Primary Care

Start: Jul 2007Est. completion: Feb 2010
Phase 4Completed
NCT00511836AlkermesVIVITROL 380 mg

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

Start: Jul 2007Est. completion: Oct 2009
Phase 4Completed
NCT00501631AlkermesVIVITROL 380 mg

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

Start: Jul 2007Est. completion: Mar 2011
Phase 3Completed
NCT00758277UCB Pharmalevetiracetam

Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients

Start: May 2007Est. completion: Dec 2009201 patients
Phase 3Completed
NCT00448825Johnson & JohnsonTopiramate + Cognitive Behavioral Therapy

Novel Pharmacotherapy for Dual Dependence

Start: Mar 2007Est. completion: Jun 2013180 patients
Phase 3Unknown
NCT00382642Johnson & JohnsonOndansetron + Cognitive Behavioral Therapy

Pharmacological Treatment for Alcoholism

Start: Jun 2006Est. completion: Dec 2009283 patients
Phase 3Completed
NCT01218971AlkermesMedisorb naltrexone 190 mg

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

Start: Aug 2002Est. completion: Sep 2004
Phase 3Completed
NCT01613014AbbVieABT-436

ABT-436 for Alcohol Dependence

Start: Feb 2013Est. completion: Jul 2015150 patients
Phase 2Completed
NCT00981617AlkermesALKS33

ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence

Start: Oct 2009Est. completion: Aug 2010
Phase 2Completed
NCT03548714Alliance PharmaceuticalsPT150

Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol

Start: Sep 2018Est. completion: Jul 201910 patients
Phase 1Completed
NCT01380704AbbVieABT-436

Safety and Pharmacodynamic Study of ABT-436 in Major Depressive Disorder

Start: Jun 2011Est. completion: Sep 201151 patients
Phase 1Completed
NCT00800319AlkermesRDC-0313

ALK33-001: A Study of RDC-0313 Administered to Healthy Adults

Start: Dec 2008Est. completion: Jun 2009
Phase 1Completed
NCT00802035AlkermesBaclofen IR

ALK29-002: A Study of Baclofen Formulations in Healthy Adults

Start: Nov 2008Est. completion: Feb 2009
Phase 1Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
5 companies competing in this space