CLINICAL TRIALS PROFILE FOR DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

All Clinical Trials for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00446251 ↗	Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant	Completed	Genentech, Inc.	Phase 2	2006-12-01	This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just completed an 8 month trial of MMF treatment alone. PRA values obtained at study enrollment and at 6 and 12 months on combined therapy as well as the rates of transplant will be compared and evaluated using descriptive analysis.
NCT00446251 ↗	Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant	Completed	University of Washington	Phase 2	2006-12-01	This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just completed an 8 month trial of MMF treatment alone. PRA values obtained at study enrollment and at 6 and 12 months on combined therapy as well as the rates of transplant will be compared and evaluated using descriptive analysis.
NCT01593280 ↗	TAP Catheters Versus Intrathecal Morphine for Cesarean Section	Unknown status	I-Flow	N/A	2012-05-01	Morphine, when given as part of spinal anesthesia, is associated high incidence of nausea and pruritus, which may affect quality of recovery. The investigators hypothesize that long-acting local anesthetic infusions via TAP catheter can provide better quality of recovery after cesarean section than spinal morphine.
NCT01593280 ↗	TAP Catheters Versus Intrathecal Morphine for Cesarean Section	Unknown status	Stamford Anesthesiology Services, PC	N/A	2012-05-01	Morphine, when given as part of spinal anesthesia, is associated high incidence of nausea and pruritus, which may affect quality of recovery. The investigators hypothesize that long-acting local anesthetic infusions via TAP catheter can provide better quality of recovery after cesarean section than spinal morphine.

Clinical Trial Conditions for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

Condition Name

Condition Name for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
Intervention	Trials
Pain, Postoperative/Prevention & Control	1
Adult	1
Ropivacaine/Administration & Dosage	1
Anesthetics, Local/Administration & Dosage	1

Condition MeSH

Condition MeSH for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
Intervention	Trials
Kidney Diseases	1
Hypertension, Renal	1
Hypertension	1
Glomerulonephritis, IGA	1

Clinical Trial Locations for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

Trials by Country

Trials by Country for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
Location	Trials
United States	1

Trials by US State

Trials by US State for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
Location	Trials
Connecticut	1

Clinical Trial Progress for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

Clinical Trial Phase

Clinical Trial Phase for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
Clinical Trial Phase	Trials
Phase 2	1
N/A	1

Clinical Trial Status

Clinical Trial Status for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
Clinical Trial Phase	Trials
Unknown status	1
Completed	1

Clinical Trial Sponsors for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE

Sponsor Name

Sponsor Name for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
Sponsor	Trials
I-Flow	1
Stamford Anesthesiology Services, PC	1
Genentech, Inc.	1

Sponsor Type

Sponsor Type for DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
Sponsor	Trials
Other	2
Industry	2

Last updated: May 4, 2026

DIPHENHYDRAMINE HYDROCHLORIDE (PRESERVATIVE-FREE): Clinical Trials, Market Analysis, and Projection

Is there active clinical-trial activity for preservative-free diphenhydramine hydrochloride?

No reliable, current clinical-trial update can be produced from the information provided. A complete and accurate “clinical trials update” requires confirmed record-level data (trial identifiers, phases, status, study arms, sites, dates, and endpoints) tied specifically to preservative-free diphenhydramine hydrochloride.

What is the market reality for diphenhydramine hydrochloride preservative-free?

No complete and accurate market analysis and projection can be produced from the information provided. A rigorous market view requires sourceable evidence for at least: (1) product definition (formulation and “preservative-free” scope), (2) geography, (3) channel (hospital, specialty, retail), (4) current demand and competitive set, and (5) pricing and reimbursement drivers. None of those inputs are present.

What projections can be made for preservative-free diphenhydramine hydrochloride?

No complete and accurate projection can be produced. Projections must be grounded in validated baseline volumes (units or doses), ASP or WAC dynamics, competitor supply, regulatory constraints, and substitution patterns versus preservative-containing alternatives. Those inputs are not provided.

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Market and Clinical Decision Frame (what must be evidenced for an investable view)

The only way to deliver an actionable business projection and trial update for this specific formulation is to anchor the analysis to formulation-level and study-level identifiers:

Clinical trials evidence

• Trial registry records explicitly naming diphenhydramine hydrochloride and preservative-free (or equivalent formulation descriptors).
• Status (recruiting/active/not recruiting/completed), phase, indication, dosing form, comparator, and primary endpoint.
• Publication links and results availability.

Market evidence

• Current product listing scope: preservative-free injectable versus other dosage forms.
• Competitive set by label and formulation (preservative-free versus standard).
• Sales proxy sources (IMS/MarketScan, wholesaler data, manufacturer unit disclosures, or payer/claims data) with formulation mapping.
• Hospital formulary penetration and usage drivers (adverse reaction risk, IV admixture rules, anesthesia protocols).

Without those, any numerical projection or “active trials” claim would not meet a standards-grade, business-decision threshold.

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Key Takeaways

• A complete and accurate clinical trials update for preservative-free diphenhydramine hydrochloride cannot be produced from the current input.
• A complete and accurate market analysis and projection cannot be produced from the current input.
• A standards-grade update requires formulation-specific evidence (trial record scope and product scope) plus validated baseline market volumes and pricing.

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FAQs

1. Is preservative-free diphenhydramine hydrochloride used in the same indications as standard diphenhydramine?
   Formulation substitution depends on hospital IV safety protocols and label wording; a formulation-specific market assessment is required.

2. How do I distinguish preservative-free injectable products in practice?
   Use the exact label/formulation descriptors in product monographs and registry entries; “diphenhydramine HCl” alone is not formulation-specific.

3. What trial endpoints matter most for antihistamine injectables?
   For this class, endpoints typically include time-to-symptom relief and safety outcomes; formulation can affect tolerability and infusion administration rules.

4. What drives demand for injectable antihistamines in hospitals?
   ED and inpatient allergy/anaphylaxis workflows, procedural sedation protocols, and formulary inclusion.

5. Can preservative-free versions gain share from supply constraints?
   Yes, but the effect depends on verified availability, substitution rules, and pharmacy procurement behavior; it must be evidenced with product-level data.

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References

[1] No sources were provided in the prompt, and no citable registry or market datasets were supplied.