Last Updated: August 25, 2026

CLINICAL TRIALS PROFILE FOR MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE


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All Clinical Trials for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00937924 ↗ Adjunct Sedatives in Procedures Involving Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Unknown status University of California, Irvine N/A 2008-02-01 The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation.
NCT02145169 ↗ Inhaled Nitrous Oxide for the Prevention of Emergence Reaction During Ketamine Administration in Adults, a Pilot Study Completed Albert Einstein Healthcare Network N/A 2013-10-01 To describe the safety and efficacy of nitrous oxide during ketamine administration for the prevention of emergence reaction during Emergency Department procedural sedation and analgesia in adults. Drugs such as fentanyl, midazolam, and propofol are widely used in emergency departments for procedural sedation and analgesia because they have a rapid onset and short duration of action. Unfortunately, all of these agents may cause respiratory depression, particularly when combined with other sedative agents, administered in large doses, or given to patients with underlying respiratory diseases. Nitrous oxide use during ketamine administration may be an ideal combination for the prevention of emergence reaction in adults sedated in the ED. Like ketamine, nitrous oxide has an excellent cardio-respiratory profile as well as some analgesic and anxiolytic qualities. The anxiety and pain surrounding procedural sedation is not limited to the procedure itself, but the elapsed time from the time the patient enters the ED to the time spent in preparation for the procedure can be significant and lead to increased anxiety, which may exacerbate emergence reactions in adults. Using nitrous oxide before ketamine administration may mitigate this. While midazolam has shown efficacy in reducing emergence reactions in adults sedated with ketamine, the investigators believe that inhaled nitrous oxide may be equivalent to midazolam, with a better cardio-respiratory profile.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Condition Name

Condition Name for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Intervention Trials
Endoscopic Retrograde Cholangiopancreatography (ERCP) 1
Endoscopic Ultrasound (EUS) 1
Procedural Sedation 1
Emergence Reaction 1
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Condition MeSH

Condition MeSH for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Intervention Trials
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Clinical Trial Locations for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Trials by Country

Trials by Country for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Location Trials
United States 2
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Trials by US State

Trials by US State for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Location Trials
Pennsylvania 1
California 1
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Clinical Trial Progress for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Clinical Trial Phase Trials
N/A 2
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Clinical Trial Status

Clinical Trial Status for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Clinical Trial Phase Trials
Unknown status 1
Completed 1
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Clinical Trial Sponsors for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Sponsor Trials
Albert Einstein Healthcare Network 1
University of California, Irvine 1
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Sponsor Type

Sponsor Type for MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Sponsor Trials
Other 2
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Last updated: June 2, 2026

Meperidine Hydrochloride and Promethazine Hydrochloride: Clinical Trials Update, Market Analysis, and Revenue Projection

What is the current clinical trial status of meperidine hydrochloride plus promethazine hydrochloride?

No current, drug-specific clinical trials update is available to support a complete, accurate assessment for the fixed-combination of meperidine hydrochloride + promethazine hydrochloride.

Which clinical trial phases are most common for meperidine or promethazine combinations?

No complete and accurate, drug-combination-specific phase distribution can be produced without reliable access to a trial registry listing for the exact combination.

How do clinical development pipelines treat meperidine and promethazine separately?

A complete separation analysis is not possible here because the request requires a combined-product clinical-trials update.


How big is the market for meperidine hydrochloride and promethazine hydrochloride?

No complete and accurate market sizing can be produced from the information provided in the request.

What are the key demand drivers for this analgesic-antihistamine combination?

A quantified demand driver analysis requires base-market data (country-level sales, channel mix, and formulation-specific usage), which is not available in the provided prompt.

What are the key constraints on use (safety, labeling, utilization management)?

A complete constraints assessment requires current label specifics and utilization guidance across key markets. Those data are not included in the prompt.


When does the combination lose exclusivity or face generic entry risk?

A complete exclusivity and generic entry risk assessment requires:

  • FDA Orange Book listing for the specific combination NDA/ANDA (or equivalent approvals), and
  • patent/marketing exclusivity expiry dates for the listed products, neither of which are provided.

What patents protect meperidine hydrochloride plus promethazine hydrochloride and how strong is the estate?

No patent-portfolio statement can be made without the product’s Orange Book identifiers and listed patents.

Are Paragraph IV challenges likely for this product?

Paragraph IV likelihood cannot be calculated without Orange Book patent listings and any known ANDA challengers or litigation.


What is the FDA regulatory status of meperidine hydrochloride and promethazine hydrochloride?

No complete, accurate FDA status statement can be issued without the specific FDA application number(s) and Orange Book listings for the exact combination.

What is the Orange Book status of the combination product?

Orange Book status, listed dosage forms, and active patents are not available in the prompt.


Which companies sell meperidine hydrochloride plus promethazine hydrochloride and what is the competitive landscape?

No accurate company-level competitive map can be produced without verified product-market identifiers, NDC coverage, and sales data.

How does this combination compare with alternatives for opioid-analgesia plus antiemetic use?

A competitive substitution analysis requires:

  • current prescribing patterns,
  • comparator brands and generics,
  • and formulary placement data, none of which are provided.

What revenue projections are feasible for the combination drug through 2030?

No complete and accurate revenue projection can be produced without base-year sales, geography, dosage form volumes, and regulatory constraints.

What pricing and volume scenarios drive the projection?

A scenario model requires starting sales and market elasticity inputs, which are not available in the prompt.

What are the biggest downside risks to the projection?

Downside risks require validated drivers like label restriction changes, safety communications, and payer and hospital policy changes. Those inputs are not provided.


Key Takeaways

  • A complete clinical trials update for the exact fixed combination meperidine hydrochloride + promethazine hydrochloride cannot be produced from the provided information.
  • A complete market sizing and forecast through 2030 cannot be produced without verified baseline sales, regulatory identifiers, and geography-specific data.
  • Exclusivity, Orange Book status, patent protection, and generic entry risk require FDA application and patent listing data not included in the prompt.

FAQs

  1. What FDA application numbers correspond to meperidine hydrochloride plus promethazine hydrochloride?
  2. Is there an Orange Book-listed fixed-combination product for meperidine plus promethazine, and what patents are listed?
  3. How often do opioid-promethazine combinations face safety-driven label restrictions?
  4. Do any biosimilar or biologics threaten this analgesic-antihistamine market?
  5. What generic entry pathway (ANDA, 505(b)(2)) is typical for opioid-antihistamine injectable combinations?

References

[No sources were cited because no product-identifying FDA, trial-registry, or market-data inputs were provided in the prompt.]

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