CLINICAL TRIALS PROFILE FOR DELSYM

All Clinical Trials for DELSYM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00593957 ↗	Trial of Dextromethorphan in Rett Syndrome	Terminated	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Phase 2	2004-08-01	Increased brain glutamate and its N-methyl-D-aspartate (NMDA) receptors found in the brain of younger Rett syndrome (RTT) patients cause toxic damage to neurons (the brain's nerve cells), and contributing to EEG spikes. Dextromethorphan (DM) acts by blocking NMDA/glutamate receptors. This study is being done to determine if DM will prevent the harmful over-stimulation of the neurons thereby reducing EEG spike activity. Treatment with DM consists of one of 3 different doses (0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day), and aims to find out which dose if any will help improve EEG abnormalities, behavior, cognition, and reduce seizures, as well as improve breathing abnormalities, motor capabilities, bone density, and GI dysfunction. The study will include 90 females and males with RTT, 2 years-14.99 years of age, with a mutation in the methyl CpG binding protein 2 (MECP2) gene, and spikes on EEG, with or without clinical seizures.
NCT01441102 ↗	Dextromethorphan for Diabetic Macular Edema	Completed	The Emmes Company, LLC	Phase 1/Phase 2	2011-08-01	Background: Many people with diabetes have macular edema (swelling) at the back of the eye. Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in the swelling. A drug called dextromethorphan may help prevent the inflammation and the swelling. Dextromethorphan is approved for use as a cough medicine, but it has not been studied to see if it can help in diabetic macular edema. Objectives: To see if dextromethorphan can help treat diabetic macular edema. Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least one eye. Design: - This study lasts 2 years, and will require at least 14 visits to the National Eye Institute outpatient clinic. Study visits will be every month for the first 2 months and then every other month. Each visit will take about 2 to 4 hours. - Participants will be screened with a physical exam, medical history, eye exam, and blood tests. One eye with macular edema will be chosen as the study eye for testing. - Participants will take dextromethorphan twice a day, about 12 hours apart, for 2 years. A study diary will help keep track of the date, time, and number of pills taken. - Participants will have study visits once a month for the first 2 months and then every other month for the rest of the study. Each study visit will involve eye exams and blood and urine tests. - Four months after starting the study medication, participants may have laser surgery or other treatments for the macular edema, if it is needed.
NCT01441102 ↗	Dextromethorphan for Diabetic Macular Edema	Completed	The EMMES Corporation	Phase 1/Phase 2	2011-08-01	Background: Many people with diabetes have macular edema (swelling) at the back of the eye. Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in the swelling. A drug called dextromethorphan may help prevent the inflammation and the swelling. Dextromethorphan is approved for use as a cough medicine, but it has not been studied to see if it can help in diabetic macular edema. Objectives: To see if dextromethorphan can help treat diabetic macular edema. Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least one eye. Design: - This study lasts 2 years, and will require at least 14 visits to the National Eye Institute outpatient clinic. Study visits will be every month for the first 2 months and then every other month. Each visit will take about 2 to 4 hours. - Participants will be screened with a physical exam, medical history, eye exam, and blood tests. One eye with macular edema will be chosen as the study eye for testing. - Participants will take dextromethorphan twice a day, about 12 hours apart, for 2 years. A study diary will help keep track of the date, time, and number of pills taken. - Participants will have study visits once a month for the first 2 months and then every other month for the rest of the study. Each study visit will involve eye exams and blood and urine tests. - Four months after starting the study medication, participants may have laser surgery or other treatments for the macular edema, if it is needed.
NCT01441102 ↗	Dextromethorphan for Diabetic Macular Edema	Completed	National Eye Institute (NEI)	Phase 1/Phase 2	2011-08-01	Background: Many people with diabetes have macular edema (swelling) at the back of the eye. Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in the swelling. A drug called dextromethorphan may help prevent the inflammation and the swelling. Dextromethorphan is approved for use as a cough medicine, but it has not been studied to see if it can help in diabetic macular edema. Objectives: To see if dextromethorphan can help treat diabetic macular edema. Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least one eye. Design: - This study lasts 2 years, and will require at least 14 visits to the National Eye Institute outpatient clinic. Study visits will be every month for the first 2 months and then every other month. Each visit will take about 2 to 4 hours. - Participants will be screened with a physical exam, medical history, eye exam, and blood tests. One eye with macular edema will be chosen as the study eye for testing. - Participants will take dextromethorphan twice a day, about 12 hours apart, for 2 years. A study diary will help keep track of the date, time, and number of pills taken. - Participants will have study visits once a month for the first 2 months and then every other month for the rest of the study. Each study visit will involve eye exams and blood and urine tests. - Four months after starting the study medication, participants may have laser surgery or other treatments for the macular edema, if it is needed.
NCT01520363 ↗	Placebo Controlled Trial of Dextromethorphan in Rett Syndrome	Completed	The Johns Hopkins Institute for Clinical and Translational Research (ICTR)	Phase 2	2012-03-01	Dr. Sakkubai Naidu, Principal Investigator, is initiating a double blinded placebo controlled clinical drug trial using dextromethorphan (DM) in Rett Syndrome (RTT), at the Pediatric Clinical Research Unit (PCRU) of the Johns Hopkins Hospital/Kennedy Krieger Institute. Funding source , FDA-00PD It has been shown that receptors for a certain brain chemical called glutamate, in particular the NMDA type, are increased in the brain of young RTT patients (
NCT01520363 ↗	Placebo Controlled Trial of Dextromethorphan in Rett Syndrome	Completed	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Phase 2	2012-03-01	Dr. Sakkubai Naidu, Principal Investigator, is initiating a double blinded placebo controlled clinical drug trial using dextromethorphan (DM) in Rett Syndrome (RTT), at the Pediatric Clinical Research Unit (PCRU) of the Johns Hopkins Hospital/Kennedy Krieger Institute. Funding source , FDA-00PD It has been shown that receptors for a certain brain chemical called glutamate, in particular the NMDA type, are increased in the brain of young RTT patients (

Clinical Trial Conditions for DELSYM

Condition Name

Condition Name for DELSYM
Intervention	Trials
Rett Syndrome	2
Diabetic Macular Edema	1
Pain, Postoperative	1
Colitis, Ulcerative	1

Condition MeSH

Condition MeSH for DELSYM
Intervention	Trials
Syndrome	2
Rett Syndrome	2
Edema	1
Pain, Postoperative	1

Clinical Trial Locations for DELSYM

Trials by Country

Trials by Country for DELSYM
Location	Trials
United States	5

Trials by US State

Trials by US State for DELSYM
Location	Trials
Maryland	3
Florida	1
California	1

Clinical Trial Progress for DELSYM

Clinical Trial Phase

Clinical Trial Phase for DELSYM
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for DELSYM
Clinical Trial Phase	Trials
Terminated	2
Completed	2
Withdrawn	1

Clinical Trial Sponsors for DELSYM

Sponsor Name

Sponsor Name for DELSYM
Sponsor	Trials
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	2
The Emmes Company, LLC	1
The EMMES Corporation	1

Sponsor Type

Sponsor Type for DELSYM
Sponsor	Trials
Other	4
Industry	3
NIH	1

DELSYM Market Analysis and Financial Projection

Last updated: February 10, 2026

What Is the Current Status of Clinical Trials for Delsym?

Delsym is an over-the-counter cough suppressant containing dextromethorphan (DXM). It is primarily marketed for short-term relief of cough related to colds and respiratory illnesses. As of 2023, there are no ongoing clinical trials registered on ClinicalTrials.gov explicitly focusing on Delsym (or its active ingredient, DXM) for new indications. The drug maintains its approved use under OTC status, with no recent or active trials aimed at expanding its therapeutic scope.

Are There Any New Developments in Market Authorization or Labeling?

Delsym's market authorization remains consistent across major markets. The U.S. Food and Drug Administration (FDA) approved its OTC label for cough suppression based on existing safety and efficacy data. There have been no recent modifications or new approvals for Delsym.

Similarly, there are no indications of regulatory re-evaluation or re-labeling efforts that could impact its market standing in key regions like the U.S. or Europe.

What Is the Market Size and Sales Performance?

Delsym is a leading brand in OTC cough suppressants. The U.S. market for cough and cold products was valued at approximately $8.2 billion in 2022, with dextromethorphan accounted for a significant share. Delsym, owned by Reckitt Benckiser, holds an estimated 25% market share within OTC cough suppressants based on sales volume and revenue figures.

In 2022, Delsym generated approximately $380 million in U.S. sales, maintaining its position as a top-selling cough suppressant. Sales are driven by retail chains, drugstores, and online platforms.

Global sales data are less precise but estimated to contribute an additional $50–$70 million annually outside the U.S., with growth potential in Asian markets where OTC medicines are gaining popularity. The overall OTC cough suppressant market global value stood at roughly $3.5 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of around 3% through 2027.

What Are the Competitive Dynamics?

Delsym faces competition primarily from other OTC brands containing dextromethorphan, such as Robitussin, Halls, and Store brands. Its unique selling points include a 12-hour extended-release formulation and a reputation for reliability.

New entrants include natural and plant-based cough remedies, which appeal to consumers seeking alternative options. These products are not direct competitors but influence consumer preferences.

Prescription cough suppressants, such as codeine or hydrocodone, are not in direct competition in OTC markets but represent alternatives for severe cough cases.

What Is the Outlook and Future Market Projection?

The OTC cough suppressant segment is expected to grow modestly, driven by aging populations and increased awareness of cold and flu remedies. Dextromethorphan's status as an OTC drug limits regulatory risk but constrains clinical development.

Potential growth avenues for Delsym include:

• Formulation Innovation: A shift toward combination products for multi-symptom relief.
• Market Expansion: Penetration into emerging markets with expanding OTC healthcare access.
• Consumer Trends: Rising preference for convenience and long-lasting formulations.

No substantial clinical trial pipeline exists to support new indications or reformulations for Delsym. The market's future hinges on marketing, distribution, and consumer preferences rather than product innovation or regulatory changes.

Key Takeaways

• Delsym remains an OTC mainstay with no active clinical trials for new indications.
• Market presence is strong in the U.S., with estimated sales of $380 million in 2022.
• The global cough and cold market is steady, with OTC products like Delsym expected to grow at low single-digit CAGR.
• Competition is intense from both branded and generic OTC formulations.
• Future growth depends on marketing, regional expansion, and consumer trends rather than new product development.

FAQs

1. Are there ongoing clinical trials for Delsym’s active ingredient, dextromethorphan?

No. As of 2023, no clinical trials are specifically registered for dextromethorphan aimed at new indications. Most research is outdated or focuses on abuse potential or pharmacokinetics.

2. Could regulatory changes impact Delsym’s OTC status?

While regulatory standards evolve, Delsym has maintained compliance. A major reformulation or safety concern could alter its OTC status, but no imminent regulatory actions are pending.

3. How does Delsym compare to prescription cough suppressants?

Delsym contains dextromethorphan, which is less potent than prescription opioids like codeine but offers a safer OTC option. It is suitable for short-term cough relief but less effective for severe or persistent coughs classified in clinical settings.

4. What are the licensing and patent considerations for Delsym?

Delsym's patent protections expired long ago, leaving the formulation open to generics. Its brand recognition sustains premium pricing despite generic competition.

5. What are potential risks to Delsym’s market share?

Market share could decline due to shifts toward natural remedies, increased generic competition lowering prices, or regulatory measures restricting dextromethorphan sales due to abuse concerns.

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Citations

[1] IQVIA. (2022). "OTC Cold and Cough Market Data."
[2] U.S. Food and Drug Administration. (2023). "OTC Drug Labeling & Regulations."
[3] Market Research Future. (2022). "Global Cough and Cold Remedies Market Size."
[4] Reckitt Benckiser. (2023). "Delsym Product Profile and Sales Data."