Robitussin

(Dextromethorphan)

Phase 3Small molecule

Dextromethorphan is used to relieve coughs caused by colds, flu, or other respiratory conditions. It works by reducing the cough reflex in your brain rather than treating the underlying cause of the cough.[1] Robitussin is currently being investigated across 9 indications[3], with its most advanced program in Phase 3.[1]

Robitussin is one of 151 small molecule programs targeting Attention Deficit Hyperactivity Disorder. It is currently in Phase 3.

Indications

Total Trials

Active Trials

150

Competitors

Pipeline

Status by Indication[3][1]

Indication

Attention Deficit Hyperactivity DisorderActive, not recruiting

Toxic EncephalopathyActive, not recruiting

NeurotoxicityActive, not recruiting

Obstructive Sleep ApneaActive, not recruiting

InteractionWithdrawn

OCDRecruiting

UltrasoundActive, not recruiting

SystemicActive, not recruiting

Attention Deficit Hyperactivity DisorderPreclinical

Active, not recruiting

Toxic EncephalopathyPreclinical

Active, not recruiting

NeurotoxicityPreclinical

Active, not recruiting

Obstructive Sleep ApneaPreclinical

Active, not recruiting

InteractionPhase 3

Withdrawn

OCDPhase 2

Recruiting

UltrasoundPhase 1

Active, not recruiting

SystemicPhase 1

Active, not recruiting

Competition

Competitive Landscape

62 competitors in Interaction

#DrugCompanyPhaseTrials

Versed

CConrado Roberto Hoffmann Filho

Approved

91 2

Epsom Salt

FFresenius Kabi USA, LLC

Approved

1 3

Rifadin

Sanofi

Phase 2

34 4

Robitussin

Pfizer

Phase 3

10 5

Sporanox

SSebela Pharmaceuticals Development LLC

Phase 2

77 6

Rifampicin

Boehringer Ingelheim

Phase 3

22 7

Crestor

AstraZeneca

Phase 1

61 8

Tegretol

Novartis

Phase 1

16 9

Lanoxin

Oxycontin

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Hodgkin Lymphoma

NCT06383338

Phase 2Recruiting

OCD

NCT04899687

Phase 1Recruiting

Chronic Pain

NCT05068791

Q4 2027

Phase 1Recruiting

Study completion

NCT06772753

Q1 2030

Phase 1Recruiting

Older Adults (50-90 Years)

NCT07386730

Q4 2030

Phase 1Recruiting

Ulcerative Colitis

NCT07665723

Clinical

Trials by Indication[1]

Interaction10 trials

Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation

Completed· GSK logo

GSK·Phase 1·NCT00964106·87 enrolled

Safety, Blood Levels, Drug Interaction and Effects of Repeated Doses of GSK1034702

Completed· GSK logo

GSK·Phase 1·NCT00950586·48 enrolled

Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects

Not yet recruiting·JJemincare·Phase 1·NCT06348290·72 enrolled

Show 7 more trials

Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir

Completed· Novartis logo

Novartis·Phase 1·NCT05236530·48 enrolled

PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates

Completed·MMirati Therapeutics Inc.·Phase 1·NCT04887194·40 enrolled

Drug Interaction Study of CT1812 in Healthy Volunteers

Completed·CCognition Therapeutics·Phase 1·NCT03716427·16 enrolled

A Drug Interaction Study of LY3871801 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05602675·39 enrolled

Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study

Withdrawn· Takeda logo

Takeda·Phase 4·NCT02760615

Drug-drug Interaction Study of KL1333 in Healthy Subjects

Completed·AAbliva AB·Phase 1·NCT04643249·14 enrolled

Drug Interaction Study of Darunavir/Ritonavir and Lopinavir/Ritonavir on GSK2248761 PK and CYP450 Probe Drugs

Completed· GSK logo

GSK·Phase 1·NCT00920088·24 enrolled

Rett syndrome4 trials

Placebo Controlled Trial of Dextromethorphan in Rett Syndrome

Completed·HHugo W. Moser Research Institute at Kennedy Krieger, Inc.·Phase 2·NCT01520363·57 enrolled

Study of the Pathogenesis of Rett Syndrome

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·N/A·NCT00004807·120 enrolled

Trial of Dextromethorphan in Rett Syndrome

Terminated·HHugo W. Moser Research Institute at Kennedy Krieger, Inc.·Phase 2·NCT00593957·38 enrolled

Show 1 more trial

Independent Studies of Dextromethorphan and of Donepezil Hydrochloride for Rett Syndrome

Unknown status·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00069550·90 enrolled

Tics2 trials

Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01766050·45 enrolled

Endobiotics for Phenotyping of Human Cytochrome P450 Enzymes

Completed·JJules Desmeules·N/A·NCT04188028·40 enrolled

Methadone2 trials

Effects of Dextromethorphan on Opioid Tolerance in Methadone Patients - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000352

Combined Therapy of Methadone and Dextromethrophan

Unknown status·NNational Cheng-Kung University Hospital·Phase 3·NCT01189097·1,500 enrolled

Bipolar Disorder2 trials

Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder

Unknown status·NNational Cheng-Kung University Hospital·Phase 3·NCT03039842·300 enrolled

Add-on Dextromethorphan in Bipolar Disorders

Completed·NNational Cheng-Kung University Hospital·Phase 3·NCT01188265·300 enrolled

51 more indications

Female2 trials

Relative Bioavailability of Dextromethorphan Syrup in Comparison to Dextromethorphan Soft Pastilles in Healthy Male and Female Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02191709·18 enrolled

A Study of Imlunestrant (LY3484356) in Female Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05444556·113 enrolled

Neuropathic Pain2 trials

Study of NMDA Antagonists and Neuropathic Pain

Completed·UUniversity Hospital, Clermont-Ferrand·Phase 2·NCT01602185·7 enrolled

Dextromethorphan Versus Placebo for Neuropathic Pain

Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 2·NCT00001344·129 enrolled

Ulcerative Colitis2 trials

A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03358706·28 enrolled

A Phase I, Multicenter, Open-Label, Single-Agent Study to Assess the Pharmacokinetics of Cytochrome P450 Substrates After Treatment With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis

Recruiting· Roche logo

Roche·Phase 1·NCT07665723·25 enrolled

Major Depressive Disorder2 trials

Repurposing of Dextromethorphan as an Adjunct Therapy in Patients With Major Depressive Disorder

Completed·—·Phase 4·NCT05181527·60 enrolled

Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder

Completed·JJohns Hopkins University·Phase 1·NCT04226352·5 enrolled

Spinal Cord Injury2 trials

Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination Clinical Trial

Completed·—·Phase 2·NCT02218203·26 enrolled

Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial

Completed·—·Phase 2·NCT01435798·26 enrolled

Schizophrenia2 trials

Add-On Therapy to Risperidonein Schizophrenia

Completed·NNational Cheng-Kung University Hospital·Phase 2/3·NCT01189006·161 enrolled

Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia

Completed·—·Phase 4·NCT05944510·40 enrolled

Irritable Bowel Syndrome1 trial

Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome

Completed·UUS Department of Veterans Affairs·Phase 2·NCT00108446

Advanced Solid Tumors1 trial

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT03864042·56 enrolled

Neurotoxicity1 trial

A Pilot Study of Dextromethorphan for the Prevention and Treatment of Methotrexate Neurotoxicity

Terminated·UUniversity of Medicine and Dentistry of New Jersey·N/A·NCT00176553·20 enrolled

Psoriasis1 trial

Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02397382·16 enrolled

Gulf War Illness1 trial

Trial of Naltrexone and Dextromethorphan for Gulf War Illness

Completed·—·Phase 2·NCT02206490·60 enrolled

Adult1 trial

Study of SHP620 (Maribavir) in Healthy Adults

Completed· Takeda logo

Takeda·Phase 1·NCT02775240·18 enrolled

Ultrasound1 trial

Pharmacological Mechanisms of Low-intensity Focused Ultrasound for Motor Cortex Neuroplasticity

Active, not recruiting·UUniversity Health Network, Toronto·Phase 1·NCT04923659·20 enrolled

Sleep1 trial

Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep

Completed·PPenn State University·Phase 1·NCT00127686·105 enrolled

Pediatric Patients1 trial

A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients

Completed·AArlyne Thung·Phase 2·NCT03714919·10 enrolled

Type 2 Diabetes Mellitus1 trial

A Study to Investigate the Glucose Lowering Effects of Dextromethorphan Alone or in Combination With Sitagliptin in Subjects With Type 2 Diabetes Mellitus (T2DM) After an Oral Glucose Tolerance Test

Completed·PProfil Institut für Stoffwechselforschung GmbH·Phase 2·NCT01936025·34 enrolled

Transcranial Direct Current Stimulation1 trial

Pilot Study Using an NMDA Antagonist to Modulate Transcranial Direct Current Stimulation (tDCS) Effects on Sensory Discrimination

Unknown status·UUniversity of Ottawa·Phase 1/2·NCT02426983·12 enrolled

Obstructive Sleep Apnea1 trial

Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Completed·VVirginia Commonwealth University·N/A·NCT00310323·69 enrolled

Hyperalgesia1 trial

Hyperalgesia in Methadone Patients: Can it be Treated?

Unknown status·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00333242·40 enrolled

Drug Interactions1 trial

Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents

Completed·AAegerion Pharmaceuticals, Inc.·Phase 2·NCT00359281·125 enrolled

Prostate Cancer1 trial

A Study to Evaluate How Daily Dosing With Enzalutamide Affects the Metabolism of Caffeine and Dextromethorphan in Men With Prostate Cancer

Completed· Astellas logo

Astellas·Phase 1·NCT02225093·12 enrolled

Drug Metabolism1 trial

KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism

Completed·HHelsinki University Central Hospital·N/A·NCT06566794·12 enrolled

Genetic Polymorphism1 trial

Impact of Genetic Polymorphism on Drug-Drug Interactions Involving CYP2D6

Completed·JJules Desmeules·N/A·NCT03054220·34 enrolled

Oral1 trial

A Study to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail in Healthy Subjects

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03058419·16 enrolled

Dietary Supplements1 trial

Licorice Botanical Dietary Supplements - Metabolism and Safety in Women

Completed·UUniversity of Illinois at Chicago·Phase 1·NCT03948243·19 enrolled

Monotherapy1 trial

Dextromethorphan, Memantine Monotherapy, or Combined Use of Dextromethorphan and Memantine in Amphetamine Addiction

Unknown status·NNational Cheng-Kung University Hospital·Phase 2/3·NCT04687566·120 enrolled

Opioid Analgesia1 trial

Assessment of Opioid Analgesia in Sickle Cell

Withdrawn·—·Phase 4·NCT00513864

Acute Cough1 trial

Acute Cough Study In Children

Terminated· Pfizer logo

Pfizer·Phase 4·NCT01257542·140 enrolled

Solid Tumors1 trial

Study of Cobimetinib in Participants With Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT00467779·119 enrolled

OCD1 trial

Study of Dextromethorphan in OCD and Related Disorders

Recruiting·SStanford University·Phase 2·NCT04899687·60 enrolled

Fibromyalgia1 trial

Dextromethorphan in Fibromyalgia

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT03538054·27 enrolled

Chronic Kidney Disease1 trial

Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients

Unknown status·NNational Cheng-Kung University Hospital·Phase 3·NCT01091324·45 enrolled

OIC1 trial

Dextromethorphan to Treat Patients With Voice Spasms

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT00055549·65 enrolled

Peripheral Neuropathy1 trial

Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

Terminated·UUniversity Hospital, Clermont-Ferrand·Phase 2·NCT02271893·19 enrolled

Tonsillectomy1 trial

Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children?

Completed·—·Phase 4·NCT02727491·85 enrolled

Systemic1 trial

A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates

Active, not recruiting·AAllyx Therapeutics·Phase 1·NCT06632990·36 enrolled

ADHD1 trial

Dextromethorphan Added on for the Patients With ADHD

No longer available·TTri-Service General Hospital··NCT01787136

Facial Pain1 trial

Studies of Dextromethorphan and Topiramate to Treat Oral and Facial Pain

Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 2·NCT00001725·100 enrolled

Multiple Sclerosis1 trial

An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis

Completed· Biogen logo

Biogen·Phase 3·NCT01462318·133 enrolled

Parkinson's Disease1 trial

Dextromethorphan for the Treatment of Parkinson's Disease and Similar Conditions of the Nervous System

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 2·NCT00001365·42 enrolled

Stroke1 trial

Histamine Glutamate Antagonism in Stroke

Completed·UUniversity of Florida·Phase 2·NCT02142712·3 enrolled

Total Knee Arthroplasty1 trial

Dextromethorphan Use in Multimodal Analgesia Regimens for Total Knee Arthroplasty

Terminated·UUniversity of Southern California·Phase 4·NCT02987920·23 enrolled

Adult Subject1 trial

Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Dextromethorphan in Healthy Adult Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT01651325·24 enrolled

Phase 11 trial

A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan

Completed· Pfizer logo

Pfizer·Phase 1·NCT00788047·14 enrolled

Chronic pain1 trial

Psilocybin-facilitated Treatment for Chronic Pain

Recruiting·UUniversity of Alabama at Birmingham·Phase 1·NCT05068791·30 enrolled

Midazolam1 trial

DDI Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan

Completed·DDrugs for Neglected Diseases·Phase 1·NCT05947604·20 enrolled

Irritability1 trial

Dextromethorphan Added on for Children With Chronic Irritability

Unknown status·TTri-Service General Hospital·Phase 4·NCT05043805·120 enrolled

Intensive Care Unit1 trial

Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients

Unknown status·KKing Abdullah International Medical Research Center·N/A·NCT01553435·36 enrolled

Older Adults (50-90 Years)1 trial

A Double Blind, Randomized Trial Investigating the Safety, Feasibility, and Mechanisms of Psychedelics in Healthy Older Adults With Low Well-being as Moderated by Biomarkers for Preclinical Alzheimer's Disease

Recruiting·JJennifer Mitchell·Phase 1·NCT07386730·80 enrolled

Hodgkin Lymphoma1 trial

A Prospective Feasibility Study Investigating PhEnoconversion of CYP3A4, CYP2C19 and CYP2D6 Genotype in Paediatric and Adolescent and Young Adult patientS With an acUte diagnosiS of Hodgkin or Non-Hodgkin Lymphoma.

Recruiting·MMurdoch Childrens Research Institute·Phase 1·NCT06383338·10 enrolled

Unspecified6 trials

Vascular Endothelial Protection Effects of Dextromethorphan

Completed·NNational Cheng-Kung University Hospital·Phase 4·NCT00605605·40 enrolled

Development of Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human

Completed·IInje University·Phase 1·NCT01570569·26 enrolled

Investigation of Psychedelic Effects in Psychoactive Substances

Recruiting·JJohns Hopkins University·Phase 1·NCT06772753·50 enrolled

Show 3 more trials

A Study of IBI351 in Healthy Subjects

Completed· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT05699993·24 enrolled

Effects of Isotretinoin on CYP2D6 Activity

Completed·UUniversity of Washington·Phase 4·NCT03076021·33 enrolled

An Open-label, Fixed-sequence Study to Assess the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT07241065·42 enrolled

Sources

References

[1]
ClinicalTrials.gov — 82 trial records for Dextromethorphan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dextromethorphan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dextromethorphan. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sigma Opioid Receptor Agonist; Glutamate [NMDA] Receptor Subunit Epsilon 1 Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Pfizer

Robitussin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q1 2030

Q4 2030

Trials by Indication[1]

Interaction10 trials

Rett syndrome4 trials

Tics2 trials

Methadone2 trials

Bipolar Disorder2 trials

Female2 trials

Neuropathic Pain2 trials

Ulcerative Colitis2 trials

Major Depressive Disorder2 trials

Spinal Cord Injury2 trials

Schizophrenia2 trials

Irritable Bowel Syndrome1 trial

Advanced Solid Tumors1 trial

Neurotoxicity1 trial

Psoriasis1 trial

Gulf War Illness1 trial

Adult1 trial

Ultrasound1 trial

Sleep1 trial

Pediatric Patients1 trial

Type 2 Diabetes Mellitus1 trial

Transcranial Direct Current Stimulation1 trial

Obstructive Sleep Apnea1 trial

Hyperalgesia1 trial

Drug Interactions1 trial

Prostate Cancer1 trial

Drug Metabolism1 trial

Genetic Polymorphism1 trial

Oral1 trial

Dietary Supplements1 trial

Monotherapy1 trial

Opioid Analgesia1 trial

Acute Cough1 trial

Solid Tumors1 trial

OCD1 trial

Fibromyalgia1 trial

Chronic Kidney Disease1 trial

OIC1 trial

Peripheral Neuropathy1 trial

Tonsillectomy1 trial

Systemic1 trial

ADHD1 trial

Facial Pain1 trial

Multiple Sclerosis1 trial

Parkinson's Disease1 trial

Stroke1 trial

Total Knee Arthroplasty1 trial

Adult Subject1 trial

Phase 11 trial

Chronic pain1 trial

Midazolam1 trial

Irritability1 trial

Intensive Care Unit1 trial

Older Adults (50-90 Years)1 trial

Hodgkin Lymphoma1 trial

Unspecified6 trials

References

Drug Info

Quick Facts

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