CLINICAL TRIALS PROFILE FOR DIMENHYDRINATE

505(b)(2) Clinical Trials for dimenhydrinate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00124787 ↗	A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis	Completed	Canadian Association of Emergency Physicians	Phase 4	2005-04-01	Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
OTC	NCT00124787 ↗	A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis	Completed	St. Justine's Hospital	Phase 4	2005-04-01	Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?

All Clinical Trials for dimenhydrinate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00124787 ↗	A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis	Completed	Canadian Association of Emergency Physicians	Phase 4	2005-04-01	Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
NCT00124787 ↗	A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis	Completed	St. Justine's Hospital	Phase 4	2005-04-01	Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
NCT00791960 ↗	Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	N/A	2008-11-01	The purpose of this study will be to determine whether an intravenous dose of dimenhydrinate (also known as Gravol), given before the induction of spinal anesthesia, will decrease the incidence of intraoperative nausea and vomiting in patients undergoing Cesarean delivery. This medication is commonly given during and after the surgery if required, but it is not known whether a preventative dose will decrease the overall incidence of these side effects.
NCT01524731 ↗	The Effect of Prophylactic Antiemetic Dexamethasone on Plasma Cortisol Levels	Completed	William Li Pi Shan	N/A	2012-05-01	Dexamethasone is a synthetic corticosteroid that has been proven to be effective and relatively safe for the prophylaxis of the postoperative nausea and vomiting (PONV). However, little is known about its effect on the hypothalamic-pituitary-adrenal (HPA) axis after surgery. The investigators hypothesize that it will inhibit the normal physiologic HPA surge and reduce cortisol levels post-operatively ia a dose-dependant fashion. To answer this question, the investigators will conduct a randomized, double-blinded placebo-controlled trial with two different doses of dexamethasone in women undergoing elective gynecologic laparotomy.

Clinical Trial Conditions for dimenhydrinate

Condition Name

Condition Name for dimenhydrinate
Intervention	Trials
Postoperative Nausea and Vomiting	7
Postoperative Pain	3
Vomiting	2
Nausea	2

Condition MeSH

Condition MeSH for dimenhydrinate
Intervention	Trials
Vomiting	11
Postoperative Nausea and Vomiting	9
Nausea	9
Vertigo	3

Clinical Trial Locations for dimenhydrinate

Trials by Country

Trials by Country for dimenhydrinate
Location	Trials
Canada	10
Brazil	7
Turkey	2
Thailand	1
Jamaica	1

Clinical Trial Progress for dimenhydrinate

Clinical Trial Phase

Clinical Trial Phase for dimenhydrinate
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	9
Phase 3	3

Clinical Trial Status

Clinical Trial Status for dimenhydrinate
Clinical Trial Phase	Trials
Completed	12
Not yet recruiting	4
Recruiting	3

Clinical Trial Sponsors for dimenhydrinate

Sponsor Name

Sponsor Name for dimenhydrinate
Sponsor	Trials
Pontificia Universidade Catolica de Sao Paulo	3
Centre hospitalier de l'Université de Montréal (CHUM)	1
Preeyaporn Jirakittidul	1

Sponsor Type

Sponsor Type for dimenhydrinate
Sponsor	Trials
Other	24
Industry	3

Last updated: July 28, 2026

Clinical trials update and market projections for dimenhydrinate: what’s in the pipeline, how the market behaves, and where generics land

Dimenhydrinate remains a mature, over-the-counter (OTC) antihistamine used primarily for motion sickness and nausea. In most markets it is not an active ingredient with a single dominant “brand patent estate,” but rather a broadly available generic commodity with recurrent product-formulation and manufacturing IP around specific dosage forms, pediatric strengths, and delivery formats. Clinical-trial activity exists but is generally sparse and fragmented versus newer antiemetics.

What clinical trials are ongoing for dimenhydrinate (and how to find the latest status)?

No complete, current cross-registry clinical-trial “latest status” dataset is available in the provided material, so a definitive list of active trials, NCT numbers, and enrollment timelines cannot be produced.

What trial types matter most for dimenhydrinate?

When dimenhydrinate does appear in trials, it is usually in one of these contexts:

• Formulation or bioequivalence studies for tablet, chewable, syrup, or effervescent variants
• Comparative studies against other antiemetics/antihistamines in motion sickness paradigms
• Safety or pharmacokinetic studies in pediatric or specific-use populations (where allowed)
• Small pragmatic studies related to nausea control rather than disease-modifying endpoints

Which endpoints are typically used?

Expect endpoints that support regulatory and label claims rather than long-horizon efficacy:

• Pharmacokinetics (Cmax, Tmax, AUC)
• Pharmacodynamic proxies (nausea scores, motion sickness symptom scales)
• Time-to-onset of antiemetic effect and duration of symptom control
• Safety signals such as sedation, anticholinergic effects, and adverse-event rates

What is the current market size for dimenhydrinate and how fast is it growing?

A numeric market-size and growth-rate forecast cannot be produced without a sourced base figure (e.g., IQVIA, GlobalData, EvaluatePharma) and without a country-by-country sales dataset for dimenhydrinate. No such market dataset is included in the provided material.

Where does demand usually come from?

Commercial pull tends to be steady and tied to:

• OTC seasonal peaks linked to travel and tourism
• Broad household penetration in motion-sickness use cases
• Pediatric-access formulations (e.g., syrup/chewable) in some geographies
• Private label and generic switching driven by price

What pricing dynamics usually dominate?

Dimenhydrinate pricing behaves like a mature OTC generic:

• Margin pressure from multi-supplier generic competition
• Low willingness-to-pay unless a product differentiates (taste, dosing convenience, pediatric usability)
• Promotion and distribution rather than clinical innovation drives share movement

How do generic launches and substitution affect dimenhydrinate sales?

Because dimenhydrinate is widely generic, the principal commercial risk is not “patent cliff entry,” but ongoing share redistribution:

• Price competition increases quickly when additional generic suppliers enter a given market
• Shelf placement and pharmacy/wholesale channel contracts dominate outcomes
• Label-equivalent products with the same dosage form and route substitute rapidly

What dosage forms typically compete head-to-head?

Competitive overlap is usually strongest within:

• Oral tablets and oral suspension/syrups
• Chewable formats (where available)
• Buffered/effervescent variants in certain OTC lineups

What regulatory pathway issues matter for dimenhydrinate reformulations?

Dimenhydrinate product development in most jurisdictions follows generic and OTC-reformulation logic:

• Bioequivalence-driven abbreviated pathways (country-specific)
• Label support for pediatric dosing and motion-sickness/nausea indication wording
• Safety labeling updates to reflect adverse-event data and pharmacovigilance

What matters for OTC antiemetics?

Key regulatory friction points typically include:

• Sedation and anticholinergic warnings consistency
• Pediatric dosing restrictions and age cutoffs
• Manufacturing controls and impurity profiles
• Stability, taste masking, and excipient acceptability in pediatric liquid forms

When does dimenhydrinate lose exclusivity or face patent expiry?

Dimenhydrinate as an active ingredient is long off any meaningful primary active-ingredient exclusivity in major markets in practice. The practical “exclusivity” that can matter now is usually secondary IP:

• Formulation patents for a specific dosage form, taste-masking system, or buffered composition
• Manufacturing-process patents
• Method-of-use claims tied to specific patient subsets or specific dosing schedules (less common for a commodity OTC ingredient)

A specific exclusivity or expiry timeline cannot be stated without an identified jurisdiction-specific patent and regulatory listing dataset.

What patents protect dimenhydrinate formulations, and how strong is the patent estate?

A patent estate assessment requires a patent landscape with jurisdiction, filing history, assignees, claim scope, and expiration dates. No such landscape is provided here, so a concrete patent list, claim scope map, and strength ranking cannot be generated.

Common types of secondary IP around dimenhydrinate products

• Taste-masked oral solids and pediatric-friendly compositions
• Extended-release or modified-release attempts (if any exist in a given jurisdiction)
• Specific salt or buffering systems to improve gastric tolerance
• Scale-up manufacturing process improvements

What generic entry risks exist for dimenhydrinate (Paragraph IV vs biosimilar-style risks)?

Dimenhydrinate is not a biologic and does not carry biosimilar-style litigation risk. Generic entry is driven by:

• Generic product acceptance through bioequivalence and compendial standards
• OTC switching and distribution contracts
• Packaging, dosing convenience, and line-extension strategies

Paragraph IV litigation-style risk is only relevant if an innovator-branded product has still-active Orange Book-listed patents and if a generic applicant targets those patents. A determination cannot be made without a current Orange Book/patent listing dataset for dimenhydrinate products in the jurisdiction of interest.

How does dimenhydrinate compare with competitors in motion sickness and nausea?

Dimenhydrinate competes in OTC and low-acuity antiemetic markets with:

• Meclizine
• Doxylamine combinations (where used)
• Promethazine in some jurisdictions and settings (often prescription)
• Non-drug motion mitigation products (pressure devices, behavioral approaches)

What drives consumer and prescriber choice?

Compared across these options, the main differentiators are:

• Sedation profile and tolerability
• Onset time perception for motion use
• Label wording and dosing convenience
• Price and availability at point of sale

Typical commercial outcome

In most mature OTC categories, the “winner” is the one with:

• Lowest net price after channel discounts
• Strongest distribution and formulary placement
• Sufficient perceived safety for travel use

Market projection for dimenhydrinate: base case, upside, downside scenarios

A quantified projection (CAGR, dollar value, and volume outlook) cannot be produced without baseline market size and segmentation assumptions. No sourced dataset is included in the provided material.

What projection drivers would be used in a rigorous model?

In a standard OTC generic projection framework for dimenhydrinate, the model would typically use:

• Number of active generic SKUs and market shares by country
• Average net selling price (after rebates/discounts)
• Volume shifts due to seasonal travel patterns
• Regulatory changes to OTC labeling or pediatric restrictions
• Input cost and packaging effects on gross margin
• Competitor share movement between antihistamine-based antiemetics

Key Takeaways

• Dimenhydrinate is a mature OTC antihistamine with demand tied to motion sickness and nausea use cases and with stable, price-led generic competition.
• Current clinical-trial status and specific ongoing trials cannot be enumerated from the provided material.
• A numeric market-size and forecast cannot be produced without a sourced market baseline and segmentation dataset.
• Competitive risk is primarily channel and pricing redistribution rather than patent-driven cliff entry.
• The IP that can still matter is secondary product-formulation and manufacturing IP around specific dosage forms and pediatric usability, not primary active-ingredient exclusivity.

FAQs

1) Are there any recent FDA approvals or label changes specifically for dimenhydrinate?

No sourced FDA product-label change dataset is provided here, so a specific answer cannot be generated.

2) Does dimenhydrinate have pediatric trial requirements that differ from adult studies?

Dimenhydrinate development often includes pediatric safety and dosing support, but a jurisdiction-specific summary cannot be provided without a regulatory dossier dataset.

3) What are the most common adverse events limiting dimenhydrinate use?

Expected class effects include sedation and anticholinergic symptoms; a confirmation tied to recent pharmacovigilance summaries is not available in the provided material.

4) Which active competitors most directly substitute for dimenhydrinate in motion sickness?

Meclizine and other antihistamine-based options are typical substitutes; a quantified substitution map is not available here.

5) Is dimenhydrinate a target for reformulation patents like taste-masking or modified-release?

Commodity OTC ingredients often see secondary formulation IP, but a verified patent list for dimenhydrinate is not provided here.

References

1. [No citable sources were provided in the prompt.]