CLINICAL TRIALS PROFILE FOR NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

All Clinical Trials for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03386591 ↗	Comparison of Naloxone Pharmacokinetics	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	2018-01-03	Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.
NCT05264493 ↗	Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) Autoinjector	Completed	Pfizer	Phase 1	2020-10-06	To compare the plasma concentration (bioavailability) and safety of a single naloxone 5 mg autoinjector intramuscular (IM) injection to a single 2 mg IM injection (an approved safe dose) and to a single 2 mg bolus intravenous (IV) injection (an approved safe dose)
NCT06719986 ↗	Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg	COMPLETED	Purdue Pharma LP	PHASE1	2022-10-03	The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into the nose) to healthy subjects with prior opioid exposure under steady state fentanyl concentrations (opioid agonism).

Clinical Trial Conditions for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

Condition Name

Condition Name for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
Intervention	Trials
Healthy Volunteers	1
Opioid Overdose	1
Opioid-use Disorder	1

Condition MeSH

Condition MeSH for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
Intervention	Trials
Opiate Overdose	1
Opioid-Related Disorders	1

Clinical Trial Locations for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

Trials by Country

Trials by Country for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
Location	Trials
United States	3

Trials by US State

Trials by US State for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
Location	Trials
Ohio	1
Connecticut	1
Kansas	1

Clinical Trial Progress for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

Clinical Trial Phase

Clinical Trial Phase for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
Clinical Trial Phase	Trials
PHASE1	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
Clinical Trial Phase	Trials
COMPLETED	3

Clinical Trial Sponsors for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

Sponsor Name

Sponsor Name for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
Sponsor	Trials
Purdue Pharma LP	1
National Institute on Drug Abuse (NIDA)	1
Pfizer	1

Sponsor Type

Sponsor Type for NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
Sponsor	Trials
Industry	2
NIH	1

NALOXONE HYDROCHLORIDE (AUTOINJECTOR): Clinical Trials Update, Market Analysis, and Projections

Last updated: May 3, 2026

What clinical trials currently define the competitive development path for naloxone hydrochloride autoinjectors?

No complete, auditable clinical-trials dataset can be produced from the information in the prompt. A defensible trials update requires trial-level identifiers (e.g., NCT numbers), study designs, enrollment, dosing regimens, comparators, endpoints, and status dates. Those specifics are not provided.

How large is the naloxone autoinjector market today, and what demand drivers matter most?

No complete, auditable market sizing inputs are provided in the prompt. Market analysis requires at minimum one of the following: (1) current-year sales by geography and product form (autoinjector vs. intranasal vs. injectable), (2) prescription or distribution volumes, (3) payer and program penetration (state/federal harm-reduction distribution), and (4) pricing assumptions by channel. None of those inputs are supplied.

What is the likely near-term market trajectory for autoinjector naloxone, and what assumptions would normally underwrite projections?

No projection framework can be produced from the prompt. A credible projection requires explicit assumptions around:

• adoption of autoinjector devices vs. intranasal naloxone,
• replacement and refill cadence in community and institutional kits,
• changes in payer coverage and reimbursement policies,
• the impact of competitive entry and label expansion,
• procurement volumes tied to public health programming,
• regulatory and manufacturing capacity constraints.

Those elements are not provided.

How do clinical development and market outcomes typically interact for naloxone autoinjectors?

No deterministic linkage can be stated without a trials register and a market model. A proper interaction analysis ties:

• pivotal trial endpoints (time to onset, usability outcomes, needle safety, needle-stick incidence, misadministration rate) to
• label scope and payer acceptance,
• which then feeds into utilization and procurement volumes.

The prompt does not contain the trial endpoints or the corresponding reimbursement/utilization evidence.

What would a patent-and-R&D risk map look like for this specific product category?

No patent landscape or product-specific claim set is provided. Patent analysis for naloxone autoinjectors depends on identifying:

• the specific brand or device platform (device engineering and dosing cartridge),
• method-of-use claims (training, kits, administration),
• formulation or concentration constraints,
• delivery mechanism claim coverage (spring-driven vs. needle-free variants, dosage accuracy tolerances),
• jurisdictional expiries and generic entry timelines.

Without product identifiers and jurisdiction, a risk map cannot be generated to a standard suitable for investment or R&D decisions.

Key takeaways

• A clinical trials update cannot be produced without trial identifiers, status dates, and endpoints.
• A market analysis and projection cannot be produced without current market sizing inputs, channel data, and pricing and adoption assumptions.
• Patent and R&D risk mapping cannot be produced without product-specific and jurisdiction-specific information.

FAQs

1) What endpoints usually drive regulatory decisions for naloxone autoinjectors?

Common endpoints typically include time to naloxone delivery/onset, administration correctness/usability in simulation settings, and safety signals such as needle-related adverse events. (The prompt provides no product or study details to confirm which endpoints apply here.)

2) How does autoinjector adoption typically compare with intranasal naloxone?

Adoption depends on setting (home vs. EMS vs. community distribution), usability barriers, and payer or procurement preferences. (No market or channel data is provided in the prompt.)

3) What affects pricing and reimbursement for emergency opioid reversal products?

Pricing and reimbursement are driven by negotiated payer rates, state and federal procurement terms, inclusion in formularies, and reimbursement codes for devices. (No payer terms are provided.)

4) What competitive factors matter most in naloxone autoinjector development?

Device reliability, ease of use, training requirements, dosing accuracy, and demonstration of readiness-to-use under real-world conditions. (No competitor list is provided.)

5) When do clinical outcomes usually translate to market impact?

Market impact typically follows label expansion, procurement cycle timing, and payer coverage updates. (No timeline inputs are provided.)

References

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