Delving into the Latest Updates on Dextromethorphan Hydrobromide Hydrate with Synapse

Overview

Basic Info

SummaryDextromethorphan (DXM) is a synthetic analog of codeine, but unlike codeine, it is not a narcotic and does not have the same potential for abuse or addiction. DXM is an N-methyl-D-aspartate (NMDA) receptor antagonist, NMDA receptors are involved in pain perception and the regulation of mood, learning, and memory. DXM is a sigma-1 receptor agonist,Sigma-1 receptors are involved in many different functions, including pain perception, mood regulation, and neuroprotection. Dextromethorphan is commonly used as a cough suppressant, and it has also been investigated for its potential therapeutic effects in a variety of conditions, including neuropathic pain, depression, and addiction. Dextromethorphan was successfully tested in 1954 as part of US Navy and CIA-funded research on nonaddictive substitutes for codeine. It was approved by the FDA in 1958 as an over-the-counter antitussive.

Drug Type

Small molecule drug

Synonyms

Dextromethorphan Hydrobromide, Dextromethorphan Hydrobromide Cranules, Dextromethorphan Hydrobromide Granules

+ [30]

Target

NMDA receptor x σ1 receptor

Action

antagonists, agonists

Mechanism

NMDA receptor antagonists(Glutamate [NMDA] receptor antagonists), σ1 receptor agonists(Sigma opioid receptor agonists)

Therapeutic Areas

Respiratory Diseases

Active Indication

Dry coughCough

Inactive Indication-

Originator Organization

Shionogi Pharma Co., Ltd.

Active Organization

Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.Shionogi Pharma Co., Ltd.Procter & Gamble Australia Pty Ltd.

+ [1]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (01 Jan 1958),

Cough

Regulation-

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Structure/Sequence

Molecular FormulaC18H28BrNO2

InChIKeySTTADZBLEUMJRG-IKNOHUQMSA-N

CAS Registry6700-34-1

This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being.
The main questions it aims to answer are, does psilocybin:
1. Acutely increase complexity of EEG activity in older adults with low well-being, as modulated by the presence of biomarkers of Alzheimer's disease (AD) pathology.
2. Longitudinally decrease plasma markers of neuroinflammation, as modulated by the presence of biomarkers of AD pathology.
3. Explore longitudinal changes in autonomic physiology via wearable recording devices as well as longitudinal structural and functional brain changes measured in the MRI
Participants will be in the study for up to 3 months, which will include 3 to 4 in person visits and 3 to 4 remote visits. Most visits will be between 1 to 3 hours, but the dosing visit will last a minimum of 8 hours and could be as long as 12 hours. During the dosing visit, all participants will receive a single dose of the study drugs and dosages listed below.
Researchers will compare participants who receive the following drug options:
* A low-to-moderate dose of Psilocybin (5-10 mg)
* A moderate-to-high dose of Psilocybin (25-30 mg)
* A low-to-moderate dose of Dextromethorphan (30-60 mg)
* A moderate-to-high dose of Dextromethorphan (80-90 mg)

Start Date01 Mar 2026

Sponsor / Collaborator

The University of California, San Francisco

NCT07241065

/ Not yet recruitingPhase 1

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

The purpose of this study is to assess the effect of capivasertib on the pharmacokinetics of oral dextromethorphan in healthy participants.

Start Date28 Jan 2026

Sponsor / Collaborator

AstraZeneca PLC

[+1]

CTRI/2026/01/100036

/ Not yet recruitingNot Applicable

Efffect of iron deficiency anemia on cytochrome P450 2D6 acitivity - NIL

Start Date21 Jan 2026

Sponsor / Collaborator

PSG Institute of Medical Sciences and Research

100 Clinical Results associated with Dextromethorphan Hydrobromide Hydrate

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100 Translational Medicine associated with Dextromethorphan Hydrobromide Hydrate

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100 Patents (Medical) associated with Dextromethorphan Hydrobromide Hydrate

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2,597

Literatures (Medical) associated with Dextromethorphan Hydrobromide Hydrate

01 Apr 2026·JOURNAL OF AFFECTIVE DISORDERS

The effect of dextromethorphan on reward-related behaviors: A systematic review of preclinical and clinical evidence

Review

Author: Le, Gia Han ; Teopiz, Kayla M ; Wong, Sabrina ; McIntyre, Roger S

INTRODUCTION:

Extant literature suggests that anhedonia, defined as a loss of the ability to feel pleasure or interest, is subserved by dysregulation of reward processing in the central nervous system. Dextromethorphan (DXM), an uncompetitive N-Methyl-d-Aspartate (NMDA) receptor antagonist and sigma-1 (σ1) receptor agonist, is a glutamatergic modulator with antidepressant properties. The effect of DXM on reward-related outcomes remains inadequately characterized. Herein, we conducted a systematic review of extant literature reporting on the effects of DXM on reward-related behaviors in both preclinical and clinical studies.

METHODS:

A systematic search of the literature was conducted on online databases (PubMed, OVID, Scopus, Web of Science) of published articles from inception to January 2025. Preclinical and clinical studies that reported on the effect of DXM on reward outcomes were assessed.

RESULTS:

Preclinical studies (n = 13) indicate that administration of DXM attenuates reward-seeking behavior in rats as measured primarily by performance in the conditioned place preference test and behavioral sensitization. In a single human study (n = 1) evaluating DXM in healthy participants (n = 20), self-reported drug-liking for DXM (400 mg/70 kg) was significantly lower in comparison to psilocybin (20 mg and 30 mg) at 7 h after the dosing session.

DISCUSSION:

Extant literature suggests that DXM administration attenuates reward-related behaviors in rats. There is a paucity of human studies investigating the effect of DXM on reward outcomes. Future research should prioritize the investigation of the effect of DXM on reward function using validated reward paradigms in persons with anhedonia.

01 Feb 2026·CTS-Clinical and Translational Science

The Effect of Ecopipam on the Pharmacokinetics of Concomitant Medications

Article

Author: Schmith, Virginia D. ; Lohmer, Lauren L. R. ; Graden, Danielle ; Schleyer, Joy ; Wanaski, Stephen P.

ABSTRACT:

Ecopipam is a first‐in‐class dopamine D1 receptor antagonist under investigation for the treatment of Tourette syndrome. This open‐label, fixed‐sequence, three‐cohort study evaluated whether ecopipam induces or inhibits cytochrome P450 (CYP) 1A2, CYP2B6, CYP2C19, CYP2D6, CYP3A4, organic anion‐transporting polypeptide (OATP) 1B1, and p‐glycoprotein (P‐gp). Probe substrates were administered alone and after single or steady‐state dosing of ecopipam (1.8 mg/kg/day). Cohort 1 received standard doses of omeprazole (CYP2C19), caffeine (CYP1A2), and dextromethorphan (CYP2D6) orally, and a microdose of midazolam (CYP3A4) intravenously. Cohort 2 received a standard dose of bupropion (CYP2B6) orally. Cohort 3 received an oral solution containing microdoses of dabigatran (P‐gp), pitavastatin (OATP1B1), rosuvastatin (BCRP, OATP, and P‐gp), atorvastatin (BCRP, OATP, P‐gp, and CYP3A4), and midazolam. A total of 56 healthy individuals (median [range] age, 36.5 [19–54] years; 85.7% male) were enrolled, and 48 completed the study. Ecopipam was well tolerated in the presence and absence of probe substrates. Steady‐state ecopipam administration increased dextromethorphan exposure (> 100‐fold); decreased the AUC inf of midazolam, omeprazole, and dabigatran by 44.2%, 44.1%, and 37.9%, respectively; and decreased unconjugated bilirubin (UGT1A1) by 19.5%. Single‐dose ecopipam increased atorvastatin Cmax by 95% and rosuvastatin Cmax by 11%, whereas steady‐state ecopipam decreased the AUC inf of atorvastatin by 26.8% and rosuvastatin by 16.4%. There were no changes in caffeine, bupropion, or pitavastatin exposure. Ecopipam is a strong inhibitor of CYP2D6 and weak inducer of CYP3A4, CYP2C19, P‐gp, and UGT1A1. Ecopipam did not inhibit CYP3A4, CYP2C19, CYP2B6, CYP1A2, UGT1A1, P‐gp, or OATP1B1 and did not induce OATP1B1 or CYP2B6.

01 Feb 2026·CLINICAL PHARMACOLOGY & THERAPEUTICS

An Evaluation of the Drug Interaction Potential of Encorafenib in Combination With Binimetinib Using the Inje Cocktail in Patients With Cancer

Article

Author: Williams, Jason H. ; Wollenberg, Lance ; Matschke, Kyle ; Reddy, Micaela B. ; Del Frari, Laurence ; Gong, Jason ; Piscitelli, Joseph

A clinical drug–drug interaction (DDI) study was designed to evaluate the effect of single and multiple oral doses of encorafenib on the single oral dose pharmacokinetics (PK) of the cytochrome P450 (CYP) enzyme probe substrates, losartan (CYP2C9), midazolam (CYP3A4), caffeine (CYP1A2), omeprazole (CYP2C19), and dextromethorphan (CYP2D6) administered as a cocktail (Inje). This study was conducted, post‐approval, in patients with BRAF V600‐mutant advanced solid tumors, and aimed to address the remaining uncertainty in the DDI potential of encorafenib as a perpetrator of these CYP enzymes. Study participants received the cocktail on Days −7, 1, and 14 and continuous doses of encorafenib (450 mg q.d.) and binimetinib (45 mg b.i.d.) starting on Day 1. PK sampling and urine collection were conducted from 0 to 8 hours on cocktail administration days. PK parameters were calculated for each participant using noncompartmental analysis of concentration–time data or amount excreted for urine parameters. At steady‐state encorafenib plasma concentrations, midazolam plasma Cmax and AUC last decreased by 74% and 82%, respectively. No clinically significant DDIs were observed at encorafenib steady‐state concentrations with the other probe substrates of interest. The results from this clinical study indicate that encorafenib is a strong inducer of CYP3A (≥ 80% decrease in midazolam area under the curve (AUC)) at steady state. Based on these results regarding co‐administration with encorafenib, sensitive substrates of CYP3A should be avoided or dose adjusted based on the recommendations of their approved product labeling. This information has been included in the updated prescribing information for encorafenib.

103

News (Medical) associated with Dextromethorphan Hydrobromide Hydrate

20 Jan 2026

·firstwordpharma.com

Biopharma bites: Roche ups its spend on US facility, financial updates from AZ, Exciva, plus Capricor's DMD drug

Roche pours more capital into North Carolina manufacturing siteAstraZeneca's direct US stock listing to start in FebExciva raises €51M to fund mid-stage work on Alzheimer's agitation drugCapricor plans February submission for DMD dataRoche pours more capital into North Carolina manufacturing siteRoche's Genentech unit said Tuesday that it will more than double its investment in a biomanufacturing facility located in Holly Springs, North Carolina. The drugmaker had originally committed $700 million to construct the site, breaking ground in August. Now, it has upped its spend on the site to about $2 billion, increasing production volume and manufacturing capacity. The pharma has promised to spend $50 billion over the next five years to boost manufacturing and R&D across both its pharmaceutical and diagnostics divisions in the US.The Holly Springs facility, expected to come online by 2029, will produce treatments for metabolic conditions such as obesity. It's slated to generate more than 500 high-wage manufacturing positions and over 1500 construction jobs. AstraZeneca's direct US stock listing to start in FebAstraZeneca will withdraw from NASDAQ and begin listing on the New York Stock Exchange (NYSE) starting February 2, following through with plans outlined last September. The move affects the company's American Depositary Shares, which will be replaced on the NYSE with its ordinary shares.Prior to announcing its plans to list on the NYSE, reports had suggested that AstraZeneca CEO Pascal Soriot was considering switching the company's listing across the Atlantic amid frustration with the UK's operating environment. However, the move to the NYSE has been explained by the drugmaker as part of wider plans to double its revenue by 2030, with 50% of this coming from the US.AstraZeneca's ordinary shares are also traded on the London Stock Exchange and NASDAQ Stockholm.Exciva raises €51M to fund mid-stage work on Alzheimer's agitation drugExciva closed a €51-million ($59 million) series B round, which will primarily be used to fund a Phase II study of Deraphan for treating agitation in patients with Alzheimer's disease (AD). The German biotech's lead programme combines the NMDA receptor channel blocker dextromethorphan with EXV-801, a triple-acting agent that is a CYP2D6 inhibitor and a 5-HT2A/2C receptor inverse agonist. Exciva hopes that combining the two modes of action will deliver a broad and synergistic treatment targeting various domains of neuropsychiatric symptoms associated with dementia, without affecting the dopaminergic system and accelerating cognitive decline.The round was co-led by Gimv and EQT Life Sciences, with new investors Fountain Healthcare Partners, LifeArc Ventures, Carma Fund and Modi Ventures joining existing backers Andera Partners and LBBW.Capricor plans February submission for DMD dataAfter receiving a complete response letter (CRL) from the FDA in July, Capricor Therapeutics thinks it's now resolved all the agency's concerns with its Duchenne muscular dystrophy (DMD) treatment, deramiocel. The rejection was prompted by a lack of supporting data, but findings from the Phase III HOPE-3 study, shared in December, back Capricor's case for approval. The allogeneic cardiosphere-derived cell therapy slowed disease progression by 54% versus placebo as at 12 months as measured by the performance of upper limb total score, meeting its primary endpoint (see – KOL Views Q&A: Capricor’s deramiocel has doubts to assuage but DMD cell therapy offers intriguing commercial profile).The FDA has now indicated that the full study report from HOPE-3 will be sufficient to address the CRL, according to Capricor. The company plans to submit the data to the agency in February, after which it expects to receive a new PDUFA date for deramiocel.Elizabeth Eaton contributed to this report.

Phase 3Phase 2Clinical ResultCell Therapy

20 Jan 2026

·endpoints.news

Exciva raises $59M to fund Phase 2 test of Alzheimer’s agitation drug

Exciva has secured €51 million ($59 million) in a Series B raise to advance its candidate for a common behavioral symptom of Alzheimer’s disease into mid-stage development. The German biotech will use the proceeds to carry out a Phase 2 trial of its asset, called Deraphan, in Alzheimer’s patients with agitation. The study will enroll 300 participants across the US, UK, Europe and Canada, Exciva CEO François Conquet told Endpoints News via email. It is expected to start in the first quarter of the year. Patients with agitation behave in a restless and aggressive manner, and often resist care. More than three-quarters of Alzheimer’s patients living in nursing homes have behavioral and psychological symptoms, according to Exciva. Deraphan contains two active ingredients: an NMDA receptor channel blocker called dextromethorphan that’s been used in cough medicines for over 60 years, and a novel agent called EXV-801. The latter is an inhibitor of the CYP2D6 liver enzyme and also targets two serotonin receptors called 5-HT2A and 5-HT2C. The two compounds are “complementary” because one stops the other from being metabolized, meaning both can reach the brain and trigger the relevant neuronal targets, Conquet said. Dextromethorphan is known to be metabolized by CYP2D6, so blocking that enzyme can result in higher amounts of the drug in the body. Exciva said the combination of dextromethorphan and EXV-801 was safe and well-tolerated in a previous Phase 1 trial. Otsuka and Lundbeck’s Rexulti is the only atypical antipsychotic that has secured FDA approval for Alzheimer’s agitation, but it carries a black box warning for increased risk of mortality. Other antipsychotics that are used to treat Alzheimer’s agitation often come with severe side effects, as do benzodiazepines. The Series B raise was co-led by Gimv and EQT Life Sciences, with support from investors including LifeArc and Andera Partners. Andera also contributed to a €9 million Series A round that Exciva closed back in 2021. Exciva was founded in 2016.

Phase 1Phase 2Drug Approval

31 Dec 2025

·pharma.economictimes.indiatimes.com

Health Ministry moves to exclude syrups from OTC list

New Delhi: With rising safety concerns over syrup formulations, the Union Health Ministry is looking to revoke exemptions for the category and ‘remove’ it from the OTC drug list . In a notification dated December 29, the ministry stated “Syrup” will be omitted from the “Class of Drugs” under the Schedule K, of the Drugs Rules, 1945. The decision comes months after the deaths of at least 24 children in Madhya Pradesh, who consumed an DEG adulterated brand: Corlif cough syrup, and the death of a child in Rajasthan who was officially stated to have consumed an 'unprescribed' Dextromethorphan Hydrobromide syrup formulation. Speaking to ETPharma a senior drug regulator said that, Syrups have been a matter of scrutiny and the recent cases (Madhya Pradesh and Rajasthan) are the “possible trigger for this decision.” Moreover, the decision follows a proposal by the Central Drugs Standard Control Organisation (CDSCO) the top internal advisory body–the Drugs Consultative Committee (DCC), which at its 67th meeting last month had also recommended to delete the provided exemptions for the category. According to the committee minutes of meet, “DCC was apprised about the recent incidences due to contaminated cough syrup” and it proposed that the exemption provided under Entry no.13 of Schedule K of Drugs Rules, 1945 in respect of syrups for cough may be deleted." The decision is currently in draft form and open for stakeholder comments for 30 days from the date of its publication. Schedule K drugs are medicines which are exempted from the Chapter IV of the Drugs and Cosmetics Acts,---regulations for manufacturing and distribution—and are allowed to be sold over-the-counter (OTC). The list includes common household medicines like antiseptics, anatacids, contraceptives, which can be dispensed by non-pharmacist as well. However, with respect to cough syrups experts often caution against their unmonitored OTC warning that s it may pose health risks to children as several formulations in the category is not intended for pediatric population. "Moving syrups from the OTC list will help to curtail the potential misuse or abuse of syrups as there will not be any syrup dispensed in the absence of valid prescription," the regulator quoted above said. Safety and quality of cough syrups has been a long concern in India, and past incidents of child deaths in countries like Uzbekistan and Cameroon, linked to Indian-made products, have also triggered international scrutiny. By Abhijeet Singh ,

100 Deals associated with Dextromethorphan Hydrobromide Hydrate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Dextromethorphan Hydrobromide Hydrate	R05DA09	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Dry cough	China	Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.	01 Jan 1990
Cough	United States	Shionogi Pharma Co., Ltd.	01 Jan 1958

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06716645 (CTgov)	Phase 4	Cough \| Common Cold	244	Robitussin Maximum Strength Cough+Chest Congestion DM (Robitussin Cough Syrup (Daytime))	oiituyatlk(gkdzraekzx) = pmnofwgbpi dhhauncwjh (xshlyvkyye, ddzpfaulzf - vimdwuqqjf) View more	-	20 Feb 2026
				Robitussin Maximum Strength Nighttime Cough DM+Chest Congestion DM (Robitussin Cough Syrup (Daytime) + Robitussin Cough Syrup (Nighttime))	oiituyatlk(gkdzraekzx) = yrbjwpddav dhhauncwjh (xshlyvkyye, gxakdjbrrm - nhnswlubym) View more
NCT03076021 (CTgov)	Phase 4	-	33	isotretinoin (Pre-isotretinoin)	pvatmbmsbz(jmcxeqfzxz) = imbufmbfvz tyfftkikqi (gjuyevsvik, ugvldnkmom - qogzgcwoqt) View more	-	28 Jan 2025
				Isotretinoin (With Isotretinoin)	pvatmbmsbz(jmcxeqfzxz) = rogbdkfqea tyfftkikqi (gjuyevsvik, ibuasmrksv - ioitkshils) View more
NCT04392011 (CTgov)	Early Phase 1	-	15	midazolam HCl+dextromethorphan HBr (Drug Cocktail)	rydeaszzfk(zndbqpwwht) = tveigrddqy niqdwqzsbj (hflxeqnwdr, brlsziqduv - uhuorcmzbi) View more	-	08 Jun 2023
				Kratom (Kratom + Drug Cocktail)	rydeaszzfk(zndbqpwwht) = ztczquimzz niqdwqzsbj (hflxeqnwdr, tcduzjwfwa - boqtrojdsk) View more
CTRI/2020/06/026115 (Pubmed \| Respirology)	Not Applicable	Cough	112	Dextromethorphan syrup 30 ml (90 mg)	qiwbcazcbp(fwhvsoqyxs) = snjnafbohe umgpsplztu (xfmxejpkmm ) View more	-	10 Jan 2023
				Placebo	qiwbcazcbp(fwhvsoqyxs) = zivgchmzhd umgpsplztu (xfmxejpkmm ) View more
NCT03538054 (CTgov)	Phase 2	Fibromyalgia	27	Dextromethorphan (Dextromethorphan)	ojljunqizf(nrwtapjkik) = gztygvkawh zuelwxsjsk (azfccwpfsq, 24.32) View more	-	26 Aug 2022
				Placebo (Placebo)	ojljunqizf(nrwtapjkik) = jxwfkxtfij zuelwxsjsk (azfccwpfsq, 24.69) View more
NCT02651116 (CHPA DXM, CTgov)	Phase 4	Acute onset cough	131	Cough recording device+Dextromethorphan Hydrobromide (Dextromethorphan Hydrobromide)	gwmzcmcqqi(ovgmcxvxzl) = gxbzepzros atnemahnaj (wwbfouwdkh, 367.21) View more	-	28 Apr 2021
				Cough recording device (Placebo)	gwmzcmcqqi(ovgmcxvxzl) = rypaakjiud atnemahnaj (wwbfouwdkh, 814.33) View more
NCT03714919 (CTgov)	Phase 2	Hypertrophy of adenoids	10	dexmedetomidine+Acetaminophen+Dextromethorphan+Ketamine	thaktoncfj(ayzmlfovde) = ptfzkusjvh ehgaqnausi (tkeblzgmwm, 0) View more	-	05 Feb 2021
NCT03480009 (DexMab, CTgov)	Phase 3	Abortion, Habitual \| Pain	156	Oxycodone+Dextromethorphan Hydrobromide (Dextromethorphan, Opted for Narcotic Prescription)	foihrihibt(aedwxtkglh) = xsioljkbzq efmikvmvyq (pncjskhvvv, hdeqeaieuw - jrmgkyxfcx) View more	-	06 Aug 2020
				Avicel PH101 (Microcrystalline Cellulose NF) for Compounding+Oxycodone (Placebo, Opted for Narcotic Prescription)	foihrihibt(aedwxtkglh) = msqwjdsbhi efmikvmvyq (pncjskhvvv, ttbqkuosda - fasgmkinhv) View more
NCT01441102 (Pubmed \| Transl Vis Sci Technol)	Phase 1/2	Diabetic macular oedema	5	Dextromethorphan 60 mg	ugfqvdsomc(wfenwydapd) = rczifeuoug qiuhyztflp (jivaypspfv ) View more	-	01 Nov 2018
NCT01361217 (FLUOXETINE, CTgov)	Not Applicable	Medication interactions	10	Lovastatin+Omeprazole+midazolam+caffeine+Fluoxetine+dextromethorphan	owbqcbqcax(btpxwlkogc) = qyccoudeba qvzigjizvm (utexgsxfvx, tzovdcraxh - xrkmbhvtie) View more	-	29 Jun 2018