CLINICAL TRIALS PROFILE FOR BENYLIN

All Clinical Trials for BENYLIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.

Clinical Trial Conditions for BENYLIN

Condition Name

Condition Name for BENYLIN
Intervention	Trials
Diabetic Macular Edema	1

Condition MeSH

Condition MeSH for BENYLIN
Intervention	Trials
Macular Edema	1
Edema	1

Clinical Trial Locations for BENYLIN

Trials by Country

Trials by Country for BENYLIN
Location	Trials
United States	1

Trials by US State

Trials by US State for BENYLIN
Location	Trials
Maryland	1

Clinical Trial Progress for BENYLIN

Clinical Trial Phase

Clinical Trial Phase for BENYLIN
Clinical Trial Phase	Trials
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for BENYLIN
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for BENYLIN

Sponsor Name

Sponsor Name for BENYLIN
Sponsor	Trials
The Emmes Company, LLC	1
The EMMES Corporation	1
National Eye Institute (NEI)	1

Sponsor Type

Sponsor Type for BENYLIN
Sponsor	Trials
Industry	2
NIH	1

Last updated: May 18, 2026

BENYLIN clinical trials update, market analysis, and projection (FY2026–2036)

What is BENYLIN and what clinical trials are actively advancing right now?

BENYLIN is a non-prescription cough/cold brand (combination of cough suppressant and/or expectorant antihistamine and decongestant depending on country-specific label). Public, FDA-tracked clinical trial visibility is limited because BENYLIN products are largely marketed as legacy OTC formulations rather than as a single, globally standardized active-ingredient dossier under one brand master label.

No sufficiently specific, source-verifiable clinical-trials dataset tied to “BENYLIN” as a single drug/product can be produced from the information available here. A defensible trials update requires at least one of the following to be unambiguous: (1) exact active ingredients and strength for the market in scope, (2) the regulatory jurisdiction (FDA, MHRA, EMA, TGA, etc.), and (3) the specific corporate sponsor.

Which active ingredients are in BENYLIN and how do they change the clinical evidence landscape?

“BENYLIN” is used across multiple OTC line extensions in different jurisdictions. For patent and clinical-trials forecasting, the active-ingredient stack matters because it determines:

• Trial relevance (new formulations often reuse older actives).
• Regulatory pathway (OTC monograph style vs modern drug application pathways).
• Bioequivalence needs (if the product is reformulated).
• Whether any modern Phase 1–3 trials exist at all versus routine stability/CMC work.

Without the exact BENYLIN formulation and geography, a complete clinical and commercial analysis cannot be compiled without risking category drift to unrelated cold/cough products.

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What is the BENYLIN market size, share, and growth outlook by geography?

Which countries sell BENYLIN and which category is it in?

BENYLIN OTC cold and cough products typically sit in the:

• OTC cough and cold segment,
• Sometimes cough suppressant or expectorant sub-segment depending on the specific product line.

A market projection must specify:

• Country-by-country category definition (cough and cold OTC differs across retail and pharmacy reporting systems),
• Distribution channel (independent pharmacy vs supermarket vs online),
• Regulatory labeling (which drives substitution and switch rates).

No source-verifiable market sizing inputs can be tied to “BENYLIN” as a single brand revenue pool without the country scope and product composition.

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When does BENYLIN face exclusivity loss, patent expiry, and generic entry risks?

What patents protect BENYLIN formulations and methods of use?

BENYLIN products are typically legacy OTC products; in many markets, actives and core formulation chemistry predate modern blockbuster patent regimes. If the actives are old, the patent estate may be:

• expired,
• limited to incremental formulation, packaging, process, or brand-protected trademark/pack trade dress rather than composition-of-matter.

A litigation-grade answer (what patents protect, expiry dates, freedom-to-operate posture) requires exact formulation identifiers and jurisdictional patent families from sources such as Orange Book analogs, UKIPO/EPO, WIPO, or national registries.

No complete and accurate patent landscape can be produced from the supplied prompt alone.

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What is the Orange Book status of BENYLIN and is there an ANDA pathway risk?

Is BENYLIN FDA-approved and listed in the FDA “Orange Book”?

The Orange Book is only for approved drug products with relevant patents. OTC brands can still be listed, but “BENYLIN” is not specific enough to determine whether a single FDA NDA/BLA product exists under that name.

A reliable “Orange Book status” answer requires mapping BENYLIN to a specific FDA application number, dosage form, and strength, and then retrieving the patent list and any discontinuation or changes.

Not enough information is available here to produce that mapping without risking inaccuracies.

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What competitive landscape does BENYLIN face and how does it compare with major OTC cough/cold brands?

How does BENYLIN pricing and mix compare with comparator OTCs?

OTC cough and cold brands compete on:

• price per dose,
• pharmacy shelf placement and promotions,
• perceived efficacy by actives (e.g., dextromethorphan vs guaifenesin vs antihistamine),
• formulation differentiation (day/night variants, sugar-free, sedation profile).

A projection requires brand-level revenue and either retail scanner data or distribution-weighted market share. Those cannot be sourced to BENYLIN without specifying which BENYLIN product and which market.

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What drives BENYLIN revenue growth and what’s the downside scenario?

Demand drivers

For cough/cold OTC, revenue typically tracks:

• respiratory season intensity (winter peaks),
• public health guidance, market availability, and advertising,
• substitution patterns based on sedation and safety perceptions,
• supply continuity (API and finished goods distribution).

Downside risks

• Regulatory relabeling or restricted indications in a jurisdiction.
• Formulation changes that reduce payer and pharmacy confidence.
• Consumer shift to alternative symptom bundles or to pharmacy-only brands.
• Product recalls or supply constraints.

A numeric downside scenario requires baseline sales and sensitivity coefficients, which are not available in the prompt.

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Key Takeaways

• “BENYLIN” is not sufficiently specific to support a credible clinical-trials update, patent/exclusivity mapping, Orange Book status, or brand-level market projection without exact formulation and geography.
• OTC cough/cold brands often have minimal modern Phase 2–3 development activity, and the most material commercial impacts usually come from seasonal demand, distribution, and regulatory or formulation changes.
• A defensible FY2026–2036 forecast requires mapping BENYLIN to a specific product label (actives, strengths, dosage forms) in a defined set of countries and then sourcing sales and trials/patent records tied to those exact identifiers.

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FAQs

1. Which BENYLIN active ingredients have the strongest evidence for cough and cold symptom relief?
2. How do seasonal respiratory patterns affect OTC cough and cold brand sales like BENYLIN?
3. What OTC regulatory requirements typically govern formulation changes for cough/cold combination products?
4. Do legacy OTC brands like BENYLIN usually face patent-driven generic entry or primarily non-IP competitive pressure?
5. How can formulation variants (day vs night, sugar-free, sedation profile) change market share within cough/cold categories?

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References

No sources were used because no source-verifiable, BENYLIN-specific clinical, regulatory, patent, or market datasets could be correctly identified from the prompt.