CLINICAL TRIALS PROFILE FOR BENADRYL PRESERVATIVE FREE

All Clinical Trials for BENADRYL PRESERVATIVE FREE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00657618 ↗	Use of Sodium Stibogluconate as a Treatment for Leishmaniasis	Completed	Walter Reed Army Medical Center	Phase 1/Phase 2	2004-10-01	Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND) product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and visceral leishmanias. This drug is not licensed for commercial use in the United States because of very limited need for the product in the U.S.A. The primary objective of this protocol is to collect safety data on the use of Pentostam for treatment of laboratory-confirmed leishmaniasis with SSG 20mg/kg/d IV for 10 days or 20 days and visceral and mucocutaneous leishmaniasis with SSG 20mg/kg/d IV for 28 days. Due to low enrollment, the protocol was later amended in version 11 submitted 19May2010 in serial no. 0096) to remove the efficacy objective and only collect safety data for enrolled subjects. Prior to this amendment, data were entered on case report forms (CRFs). Per the Sponsor's discretion, CRFs were no longer required and protocol-specified treatment details and safety assessments were recorded in the patients' medical records (study file) only. No data entry or statistical analyses of patient data was conducted.
NCT00657618 ↗	Use of Sodium Stibogluconate as a Treatment for Leishmaniasis	Completed	U.S. Army Medical Research and Development Command	Phase 1/Phase 2	2004-10-01	Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND) product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and visceral leishmanias. This drug is not licensed for commercial use in the United States because of very limited need for the product in the U.S.A. The primary objective of this protocol is to collect safety data on the use of Pentostam for treatment of laboratory-confirmed leishmaniasis with SSG 20mg/kg/d IV for 10 days or 20 days and visceral and mucocutaneous leishmaniasis with SSG 20mg/kg/d IV for 28 days. Due to low enrollment, the protocol was later amended in version 11 submitted 19May2010 in serial no. 0096) to remove the efficacy objective and only collect safety data for enrolled subjects. Prior to this amendment, data were entered on case report forms (CRFs). Per the Sponsor's discretion, CRFs were no longer required and protocol-specified treatment details and safety assessments were recorded in the patients' medical records (study file) only. No data entry or statistical analyses of patient data was conducted.
NCT00657618 ↗	Use of Sodium Stibogluconate as a Treatment for Leishmaniasis	Completed	U.S. Army Medical Research and Materiel Command	Phase 1/Phase 2	2004-10-01	Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND) product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and visceral leishmanias. This drug is not licensed for commercial use in the United States because of very limited need for the product in the U.S.A. The primary objective of this protocol is to collect safety data on the use of Pentostam for treatment of laboratory-confirmed leishmaniasis with SSG 20mg/kg/d IV for 10 days or 20 days and visceral and mucocutaneous leishmaniasis with SSG 20mg/kg/d IV for 28 days. Due to low enrollment, the protocol was later amended in version 11 submitted 19May2010 in serial no. 0096) to remove the efficacy objective and only collect safety data for enrolled subjects. Prior to this amendment, data were entered on case report forms (CRFs). Per the Sponsor's discretion, CRFs were no longer required and protocol-specified treatment details and safety assessments were recorded in the patients' medical records (study file) only. No data entry or statistical analyses of patient data was conducted.
NCT00662012 ↗	Sodium Stibogluconate Treatment of Leishmaniasis	Completed	Walter Reed Army Medical Center	Phase 2	2002-06-01	Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND) product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and viseral leishmanias. This drug is not licensed for commercial use in the United States because of very limited need for the product in the U.S.A. The objective of this protocol is to provide sodium stibogluconate for the treatment of cutaneous leishmaniasis and mucosal leishmaniasis (pentavalent antimonials curently considered the drug of choice for these infections) Provide sodium stibogluconate as a second line treatment for viscerotropic and visceral leishmaniasis (liposomal amphotericin is the drug of choice for these types as it is FDA approved for vusceral leishmaniasis).
NCT00662012 ↗	Sodium Stibogluconate Treatment of Leishmaniasis	Completed	U.S. Army Medical Research and Development Command	Phase 2	2002-06-01	Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND) product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and viseral leishmanias. This drug is not licensed for commercial use in the United States because of very limited need for the product in the U.S.A. The objective of this protocol is to provide sodium stibogluconate for the treatment of cutaneous leishmaniasis and mucosal leishmaniasis (pentavalent antimonials curently considered the drug of choice for these infections) Provide sodium stibogluconate as a second line treatment for viscerotropic and visceral leishmaniasis (liposomal amphotericin is the drug of choice for these types as it is FDA approved for vusceral leishmaniasis).
NCT00662012 ↗	Sodium Stibogluconate Treatment of Leishmaniasis	Completed	U.S. Army Medical Research and Materiel Command	Phase 2	2002-06-01	Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND) product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and viseral leishmanias. This drug is not licensed for commercial use in the United States because of very limited need for the product in the U.S.A. The objective of this protocol is to provide sodium stibogluconate for the treatment of cutaneous leishmaniasis and mucosal leishmaniasis (pentavalent antimonials curently considered the drug of choice for these infections) Provide sodium stibogluconate as a second line treatment for viscerotropic and visceral leishmaniasis (liposomal amphotericin is the drug of choice for these types as it is FDA approved for vusceral leishmaniasis).

Clinical Trial Conditions for BENADRYL PRESERVATIVE FREE

Condition Name

Condition Name for BENADRYL PRESERVATIVE FREE
Intervention	Trials
Leishmaniasis	2

Condition MeSH

Condition MeSH for BENADRYL PRESERVATIVE FREE
Intervention	Trials
Leishmaniasis	2

Clinical Trial Locations for BENADRYL PRESERVATIVE FREE

Trials by Country

Trials by Country for BENADRYL PRESERVATIVE FREE
Location	Trials
United States	2

Trials by US State

Trials by US State for BENADRYL PRESERVATIVE FREE
Location	Trials
District of Columbia	2

Clinical Trial Progress for BENADRYL PRESERVATIVE FREE

Clinical Trial Phase

Clinical Trial Phase for BENADRYL PRESERVATIVE FREE
Clinical Trial Phase	Trials
Phase 2	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for BENADRYL PRESERVATIVE FREE
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for BENADRYL PRESERVATIVE FREE

Sponsor Name

Sponsor Name for BENADRYL PRESERVATIVE FREE
Sponsor	Trials
Walter Reed Army Medical Center	2
U.S. Army Medical Research and Development Command	2
U.S. Army Medical Research and Materiel Command	2

Sponsor Type

Sponsor Type for BENADRYL PRESERVATIVE FREE
Sponsor	Trials
U.S. Fed	6

Last updated: May 3, 2026

What is the clinical and market outlook for BENADRYL Preservative Free?

Benadryl Preservative Free is a consumer antihistamine product line marketed in the United States and other countries for allergy symptoms. It is not a single defined “drug asset” with a clear, sponsor-owned pipeline the way prescription biologics or small-molecule therapeutics are. Market reporting typically treats it as a formulation/label/OTC product rather than a proprietary development program. As a result, there is no unified clinical-trials register entry that can be reliably mapped to “BENADRYL Preservative Free” as a distinct investigational drug, and forecasts must be built from OTC antihistamine market behavior and brand/formulation positioning, not from trials for a new molecular entity.

Below is what can be stated cleanly and actionably from available public regulatory and market structure: what exists, what is measurable, and what investors/R&D teams can project for an OTC antihistamine franchise tied to preservative-free packaging and pediatric/avoidance use cases.

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Is “BENADRYL Preservative Free” a clinical-trials investigational drug?

No. “Benadryl Preservative Free” is marketed as an OTC antihistamine product, not as a clinical development candidate. Public clinical-trials registries typically index active investigational substances and trial protocols. OTC formulations under established active ingredients are usually not the subject of dedicated phase trials unless there is a regulatory requirement for a new strength, new dosage form, new route, or safety/efficacy change.

In practice, “preservative free” is a formulation attribute that affects manufacturing and labeling, not a new molecular entity. That means the clinical-trials update for this specific SKU is usually limited to:

• Post-market pharmacovigilance and routine safety monitoring
• Label/packaging changes and comparability work during formulation/manufacturing updates
• No phase program tied to the preservative-free attribute as a standalone clinical endpoint

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What regulatory and labeling structure governs this product?

Benadryl OTC antihistamines in the US are regulated under OTC monograph and/or NDA/BLA frameworks depending on the active ingredient and marketed status. “Benadryl” is the brand name historically associated with diphenhydramine antihistamine formulations, with different presentations (liquid, tablets, etc.) and different excipient profiles.

A “preservative free” claim usually drives:

• A change in inactive ingredients to eliminate specific preservatives
• Stability and compatibility controls for the formulation
• Labeling to support use cases such as sensitivity or pediatric administration (where appropriate)

For businesses, this means commercial outcomes track availability, substitutability, and distribution more than clinical efficacy differentiation.

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How does the OTC antihistamine market behave for brand extensions like “preservative free”?

OTC allergy relief demand is driven by:

• Seasonality (peak allergy periods in spring and summer)
• Formulary and pharmacy shelf placement
• Pediatric usage patterns (liquid formulations and dosing convenience)
• Consumer “avoidance” claims (preservative-free, dye-free, alcohol-free where offered)
• Switching behavior among antihistamines based on perceived symptom control and tolerability

Preservative-free usually plays as a margin and preference lever, not as a clinical efficacy lever. The competitive set includes:

• Generic diphenhydramine products sold in liquid and tablet forms
• Branded antihistamine competitors within OTC allergy categories
• Other sedating antihistamines with varying ingredient systems
• Non-sedating alternatives (e.g., second-generation agents) where consumers trade off drowsiness for symptom control

Net effect for forecasts: preservative-free SKUs typically grow by:

• Capturing subset demand within diphenhydramine users
• Trading up from generics where consumers pay for “cleaner” excipient profiles
• Maintaining share during short-term supply or packaging disruptions relative to preservative-containing equivalents

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What clinical-trials signals matter for OTC antihistamine brands?

For an OTC antihistamine franchise, “clinical-trials update” is less about randomized endpoints and more about whether regulators or major safety bodies issue meaningful signals affecting:

• Sedation, anticholinergic risk, and contraindication language
• Pediatric safety framing (dose guidance and age limits)
• Risk communications that change consumer and clinician behavior

For commercial projection, the key measurable signals are:

• Safety-related label changes
• FDA communications that alter pediatric dosing or warnings
• Market withdrawals or supply interruptions of specific excipient variants

For “preservative free,” any unique clinical relevance would come from a formulation-specific labeling change or stability/safety event tied to that excipient-free system.

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Market analysis: demand drivers and constraints for preservative-free antihistamine SKUs

Core demand drivers

• Allergy season pull: recurring annual demand cycles
• Pediatric convenience: liquid formats and easier dosing
• Preference for excipient avoidance: “preservative free” reduces perceived irritant or sensitivity concerns
• Retail visibility: end-cap and planogram placement in pharmacy channels

Constraints

• Substitutability: generic diphenhydramine products with similar dosing still capture much of the value chain
• Sedation perception: sedating antihistamines lose consumers to non-sedating options during preference shifts
• Regulatory tone: tighter pediatric warnings can depress category usage for certain age groups
• Manufacturing complexity: excipient-free formulations can raise cost and inventory risk if raw material supply tightens

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Commercial projection: what can be modeled for “BENADRYL Preservative Free”?

Because there is no distinct phase-development “clinical readout” for this product SKU, projections should be modeled using category and brand share mechanics:

• Category growth rate for OTC antihistamines in the relevant retail segment
• Brand penetration and pack-size mix
• Incremental capture rate from “preservative-free” preference
• Price and promo sensitivity of diphenhydramine buyers versus non-sedating alternatives

A practical projection framework:

1. Baseline: overall OTC antihistamine category revenue and unit volume trend over time
2. Share: Benadryl franchise share in diphenhydramine-containing segments
3. Variant premium: incremental price premium and promotion frequency for preservative-free SKU versus standard version
4. Seasonality: allocate units by allergy months; apply inventory lead time and shelf-through rates
5. Risk scenario:
   • Downside: label tightening or consumer shift to second-generation agents
   • Upside: improved retail velocity from preservative-free “clean label” positioning

This framework yields a forecast even without new clinical trial endpoints, because OTC brand performance is driven by retail dynamics and label/regulatory stability, not investigational programs.

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What timeline would matter operationally?

For an OTC preservative-free formulation, the timeline that affects performance is:

• Packaging and excipient supply continuity (manufacturing lead times)
• Seasonal demand windows
• Any label revisions that change usage or warnings
• Retail reset cycles (planograms and shelf placement)

A true “clinical trials update” timeline is usually absent unless the preservative-free change triggers a regulatory filing with meaningful clinical implications, which is atypical for established OTC antihistamines.

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Investment and R&D implications

For R&D

• The preservative-free attribute is a formulation and compliance exercise.
• Value creation comes from manufacturing robustness, stability, and supply economics, not from new efficacy.
• If a company is pursuing differentiation, it must target:
  • Better tolerability profile through excipient systems
  • Pediatric acceptability (taste, viscosity, dosing ease)
  • Stability shelf-life improvements that reduce stock-outs

For commercial strategy

• Protect distribution: prevent substitution losses during peak season.
• Maintain clear labeling: “preservative free” is the shelf differentiator; it must remain prominent.
• Use channel-specific economics: pharmacy and e-commerce promotions can compress or expand variant premium.

For patent strategy

• If a firm holds patents on formulation or excipient systems, the commercial relevance depends on enforceable scope. OTC antihistamine actives face genericization pressure; differentiation patents tend to focus on formulation and stability methods rather than pharmacology.

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Key Takeaways

• “BENADRYL Preservative Free” is an OTC antihistamine brand/format, not a clinical-trials investigational drug with a distinct phase program.
• A clinical-trials “update” is therefore not best represented by new efficacy readouts; it is driven by post-market safety signals and label/regulatory changes that affect the diphenhydramine category.
• Market projection should be built from OTC category seasonality, retail share mechanics, variant premium capture, and substitutability versus generics and non-sedating alternatives.
• The preservative-free claim is primarily a preference and excipient-avoidance driver, so forecast sensitivity is highest around distribution, promo discipline, and supply continuity, not around clinical endpoints.

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FAQs

1. Does BENADRYL Preservative Free have phase 1-3 clinical trials like prescription drugs?
   No. It is an OTC antihistamine product line where separate phase trials are not typically run for the preservative-free attribute.

2. What is the main differentiator for preservative-free antihistamine SKUs?
   The excipient profile and associated “preservative free” claim, which targets consumer preference and sensitivity concerns rather than new therapeutic effect.

3. What drives sales most during the year?
   Allergy season seasonality and retail execution (shelf placement, promo timing, and shelf-through).

4. How does substitutability affect pricing and share?
   Generic diphenhydramine and competing antihistamines cap price premiums; preservative-free SKUs must rely on variant preference and channel visibility.

5. What regulatory events would most impact projections?
   Label/warning changes and safety communications that alter pediatric dosing guidance, consumer use behavior, or channel recommendations.

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References

[1] U.S. Food and Drug Administration (FDA). OTC Drug Products, including antihistamine labeling and safety communications. https://www.fda.gov/drugs/over-counter-otc-drugs
[2] ClinicalTrials.gov. Search results for diphenhydramine and antihistamine investigations (general active ingredient trials). https://clinicaltrials.gov/