Selincro

(Nalmefene)

ApprovedSmall molecule

Nalmefene is used to reduce alcohol cravings and help people drink less alcohol if they have alcohol use disorder. It works by blocking the effects of alcohol in the brain.[2] Selincro is currently approved and in use across 14 indications[4].[1]

Selincro is one of 320 small molecule programs targeting Gambling Behaviour. It is currently in Approved.

Indications

Total Trials

Active Trials

319

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Gambling BehaviourApproved

Atopic EczemaApproved

Borderline Personality DisorderActive, not recruiting

Kidney DiseaseApproved

Respiratory DepressionActive, not recruiting

Opioid DependenceActive, not recruiting

Fatty Liver DiseaseApproved

Drug DependenceApproved

Non-Alcoholic SteatohepatitisApproved

Alcohol DependenceActive, not recruiting

Gambling BehaviourApproved

Approved

Atopic EczemaApproved

Approved

Borderline Personality DisorderPreclinical

Active, not recruiting

Kidney DiseaseApproved

Approved

Respiratory DepressionPhase 3

Active, not recruiting

Opioid DependenceApproved

Active, not recruiting

Fatty Liver DiseaseApproved

Approved

Drug DependenceApproved

Approved

Non-Alcoholic SteatohepatitisApproved

Approved

Alcohol DependenceApproved

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

245 competitors in Kidney Disease

#DrugCompanyPhaseTrials

Selincro

IIndivior Inc.

Approved

23 2

Reata

Biogen

Phase 3

1 3

Victoza

Novo Nordisk

Phase 3

1 4

Invirase

Roche

Phase 3

1 5

Edarbi

Takeda

Phase 3

1 6

Zemplar

AbbVie

Phase 3

1 7

Evrenzo

Astellas

Phase 3

1 8

Rituxan

Gazyva

Myfortic

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Not yet recruiting

Primary Biliary Cholangitis

NCT06733519

Q3 2027

Phase 3Recruiting

Treatment

NCT05540288

Clinical

Trials by Indication[1]

Alcohol Dependence5 trials

Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use

Completed· Lundbeck logo

Lundbeck·Phase 4·NCT02197598·45 enrolled

Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.

Withdrawn·—·Phase 3·NCT02824354

Efficacy of Nalmefene in Patients With Alcohol Dependence

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT00812461·678 enrolled

Show 2 more trials

Efficacy of Nalmefene in Patients With Alcohol Dependence

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT00811720·598 enrolled

Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT00811941·665 enrolled

Alcohol2 trials

St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene

Completed·—·Phase 1/2·NCT03278886·11 enrolled

Single-dose of Nalmefene to Modulate Neural Alcohol Cue Reactivity

Terminated·—·Phase 1·NCT02372318·23 enrolled

Borderline personality disorder1 trial

Nalmefene in Alcohol Dependence and Borderline Personality Disorder

Unknown status·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·N/A·NCT02752503·30 enrolled

Primary Biliary Cholangitis1 trial

TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis

Not yet recruiting·TTharimmune Inc·Phase 2·NCT06733519·40 enrolled

Parkinson's Disease1 trial

Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study

Unknown status·UUniversity Hospital, Clermont-Ferrand·Phase 2·NCT02934919·30 enrolled

12 more indications

Treatment1 trial

NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions

Recruiting·NNantes University Hospital·Phase 3·NCT05540288·266 enrolled

Renal Impairment1 trial

Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy Subjects

Completed· Lundbeck logo

Lundbeck·Phase 1·NCT01934166·32 enrolled

Respiratory Depression1 trial

Nalmefene vs Naloxone for the Treatment of Recurrent Respiratory Depression After Opioid Overdose

Withdrawn·UUniversity of New Mexico·Phase 3·NCT06408714

Recovery1 trial

Patient Driven Recovery With Nalmefene and Coaching

Completed·YYale University·Phase 1·NCT03279562·10 enrolled

MPA1 trial

Use of Selincro and Impact on Usual Practice

Completed·—··NCT02492581·700 enrolled

Alcohol Use Disorder1 trial

Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects

Completed·PProf. Daniele Zullino·Phase 2·NCT03034408·37 enrolled

Smoking Cessation1 trial

Nalmefene Smoking Cessation Study

Completed·SSomaxon Pharmaceuticals·Phase 2·NCT00202696·76 enrolled

Acute Lymphoblastic Leukemia1 trial

Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT03129347·14 enrolled

Dexmedetomidine1 trial

Effect of Dexmedetomidine Combined With Low-dose Nalmefene on Preventing Remifentanil-induced Postoperative Hyperalgesia

Completed·TTianjin Medical University General Hospital·N/A·NCT03096730·150 enrolled

General Anesthesia1 trial

Effect of Nalmefene on the Quality of Resuscitation in Patients Under General Anesthesia

Completed·RRenJi Hospital·Phase 4·NCT04713358·542 enrolled

AUD1 trial

Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 1·NCT02639273·13 enrolled

Unspecified2 trials

An Evaluation of The Absolute Bioavailability of TH104

Completed·TTharimmune Inc·Phase 1·NCT06198686·20 enrolled

Pharmacokinetic Evaluation of Intranasal Nalmefene

Completed·OOpiant Pharmaceuticals Inc·Phase 1·NCT04759768·68 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 17, 1995

REVEX

NDA NDA020459

May 22, 2023

OPVEE

NDA NDA217470

Aug 7, 2024

ZURNAI (AUTOINJECTOR)

NDA NDA218590

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Nalmefene. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Selincro drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nalmefene compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nalmefene. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA218590). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Selincro. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Indivior Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Delta Opioid Receptor Antagonist; Mu Opioid Receptor Antagonist; Kappa Opioid Receptor Partial Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: IIndivior Inc.

Patent Landscape[6]

Patent Cliff

Jul 10, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11458091Jul 10, 2038

11865112Nov 5, 2039

11857547Nov 5, 2039

12290596Aug 4, 2042

Selincro

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Trials by Indication[1]

Alcohol Dependence5 trials

Alcohol2 trials

Borderline personality disorder1 trial

Primary Biliary Cholangitis1 trial

Parkinson's Disease1 trial

Treatment1 trial

Renal Impairment1 trial

Respiratory Depression1 trial

Recovery1 trial

MPA1 trial

Alcohol Use Disorder1 trial

Smoking Cessation1 trial

Acute Lymphoblastic Leukemia1 trial

Dexmedetomidine1 trial

General Anesthesia1 trial

AUD1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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