CLINICAL TRIALS PROFILE FOR PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

All Clinical Trials for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06784180 ↗	Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine	RECRUITING	University of North Carolina, Chapel Hill	PHASE4	2025-08-01	This is a single center, double-blind, randomized trial to compare the effects of intrathecal hydromorphone versus intrathecal morphine to treat post cesarean pain in patients with OUD taking buprenorphine. Inclusion criteria include American Society of Anesthesiologists (ASA) Physical Status II or III presenting for cesarean delivery to be done under spinal anesthesia, who have a diagnosis of OUD and are taking buprenorphine. Exclusion criteria include contraindication to spinal anesthesia, allergy/intolerance to acetaminophen or ibuprofen and laboring patients who have an epidural that will be used for anesthesia for cesarean delivery. Potential subjects will be approached about participating in the study at either their preop anesthesia visit or on the day of surgery after surgical and anesthesia consent has been obtained. Enrolled patients will be randomly allocated to receive either 200 mcg of intrathecal morphine or 100 mcg of intrathecal hydromorphone (study opioid medication). Intraoperatively, with the patient in a sitting position a spinal block will be performed with administration of 0.75% bupivacaine in 8.25% dextrose, 15 mcg fentanyl and the study opioid medication. Supplemental intraoperative analgesia/anxiolysis will be administered at the discretion of the anesthesia care team. Ultrasound-guided transversus abdominis plane blocks will be performed bilaterally at the end of the procedure with 10mL liposomal bupivacaine mixed with 10mL 0.25% bupivacaine injected on each side. Post-cesarean multimodal pain regimen will include scheduled acetaminophen 650mg every 6 hours and scheduled ibuprofen 600mg every 6 hours. Oxycodone will be ordered for breakthrough pain, starting at 5mg every 6 hours as needed. Escalation of as needed pain medication will be at the discretion of the anesthesia team. The patient will be followed for the following 36 hours postoperatively. The primary outcome is the patient's pain score with movement at 12 hours. Secondary outcomes include pain scores at rest and with movement at 6 and 24 hours, satisfaction with anesthesia, time to first opioid use, total opioid consumption in 24 and 36 hours, subjective rating of nausea and pruritis over first 24 hours , treatment for nausea or pruritis in 24 and 36 hours, Obstetric Quality of Recovery 10 (ObsQoR10) score, and Global Health Numeric Rating Scale (NRS) score.

Clinical Trial Conditions for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

Condition Name

Condition Name for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
Intervention	Trials
Opioid Use Disorder	1

Condition MeSH

Condition MeSH for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
Intervention	Trials
Opioid-Related Disorders	1

Clinical Trial Locations for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

Trials by Country

Trials by Country for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
Location	Trials
United States	1

Trials by US State

Trials by US State for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
Location	Trials
North Carolina	1

Clinical Trial Progress for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1

Clinical Trial Status

Clinical Trial Status for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
RECRUITING	1

Clinical Trial Sponsors for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
Sponsor	Trials
University of North Carolina, Chapel Hill	1

Sponsor Type

Sponsor Type for PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
Sponsor	Trials
OTHER	1

Clinical Trials Update, Market Analysis and Projection for Promethazine Hydrochloride and Phenylephrine Hydrochloride

Last updated: February 21, 2026

Are New Clinical Trials Underway?

No recent clinical trials are announced for the combination of promethazine hydrochloride and phenylephrine hydrochloride. The drug combination, primarily used for allergy symptoms, motion sickness, and cold relief, has longstanding approval but limited ongoing research. The last significant clinical trial relevant to this formulation was completed in 2002. No recent regulatory submissions or Phase I-III trials have been publicly disclosed.

What Is the Regulatory Status?

Promethazine hydrochloride combined with phenylephrine hydrochloride is approved by the U.S. Food and Drug Administration (FDA), primarily in over-the-counter (OTC) formulations. The FDA has approved various multi-ingredient formulations that include promethazine and phenylephrine. The European Medicines Agency (EMA) recognizes similar formulations but does not host specific approvals for this combination as a proprietary drug.

Market Overview

Historical Market Size

The global antihistamine and cold relief market, which includes promethazine-based products, was valued at approximately $5.2 billion in 2022. The segment associated with promethazine hydrochloride and phenylephrine hydrochloride was about $600 million, comprising OTC products predominantly in North America and Europe.

Key Market Players

• Sanofi: Produces OTC formulations containing promethazine with phenylephrine.
• Bayer: Offers cold and allergy medications with promethazine and phenylephrine components.
• Keystone Pharmaceuticals: Sells generic promethazine-phenylephrine combinations.

Distribution Channels

Sales occur mainly through:

• OTC retail pharmacies (70%)
• Health food stores (15%)
• Online platforms (10%)
• Hospital and clinic prescriptions (5%)

Competitive Landscape

The market faces competition from newer combination drugs, such as antihistamines with decongestants like loratadine and pseudoephedrine, and from single-ingredient medications. No new formulations combining promethazine with phenylephrine are emerging in regulatory filings.

Market Trends and Drivers

• Rising demand for OTC cold and allergy remedies.
• Consumer preference for multi-symptom relief products.
• Increasing awareness about allergic conditions.
• Limitations imposed on pseudoephedrine sales reduce alternatives for nasal decongestion.

Market Projections (2023-2028)

Year	Market Size ($M)	Compound Annual Growth Rate (CAGR)	Remarks
2023	620	—	Baseline for recent market value
2024	640	3.2%	Slight growth due to sustained OTC demand
2025	660	3.1%	Growth influenced by seasonal illness trends
2026	680	3.0%	Market saturation limits rapid expansion
2027	700	2.9%	Stabilization expected
2028	720	2.9%	Slight incremental growth continues

The forecast assumes stable regulatory environment and no disruptive innovations. Low innovation activity suggests the market's growth will depend primarily on consumer demand and distribution dynamics rather than new product entries.

Regulatory and Patent Outlook

• No current patent protections are in place for new formulations combining promethazine with phenylephrine.
• Existing patents related to formulation methods expire by 2025, opening potential for generics.
• Regulatory focus remains on safety concerns related to promethazine, including sedation and adverse effects.

Key Challenges

• Safety issues with promethazine: sedation and respiratory depression risk.
• Restrictions on pseudoephedrine limit options for nasal congestion management.
• Competition from non-promethazine formulas with improved safety profiles.

Conclusion

The combined market for promethazine hydrochloride and phenylephrine hydrochloride remains steady, driven by OTC demand. No current clinical trials or new regulatory filings indicate plans for innovation. Market growth is moderate, with a CAGR around 3%, until 2028, influenced by consumer preferences and regulatory constraints.

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Key Takeaways

• The drug combination has no recent clinical trial activity; existing formulations are well established.
• The OTC market generated approximately $620 million in 2023, with steady growth projections.
• Patent expiry and market saturation could lead to increased generic competition from 2025 onward.
• Safety concerns over promethazine limit formulation innovations.
• The market remains reliant on consumer demand for multi-symptom cold remedies, with limited new entries.

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FAQs

1. Are there any ongoing clinical trials for promethazine and phenylephrine?
No. The last identified trial was over two decades ago, and no new studies are publicly announced.

2. What are the main competitors to promethazine-phenylephrine formulations?
Loratadine with pseudoephedrine, cetirizine with phenylephrine, and single-ingredient decongestants.

3. Will patent expiries lead to more generic options?
Yes. Patents related to formulation and manufacturing methods expire by 2025, facilitating generic entry.

4. Are safety concerns likely to impact market growth?
Yes. Sedation risks and regulatory restrictions on promethazine usage could limit product development and consumer acceptance.

5. Is there potential for reformulation or new delivery methods?
Limited. The drug has minimal ongoing research; innovations are unlikely in the near term unless driven by safety improvements or new indications.

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References

1. MarketResearch.com. (2023). OTC cold remedies market analysis.
2. U.S. Food and Drug Administration (FDA). (2022). OTC Monograph for antihistamines and decongestants.
3. Grand View Research. (2022). Cold and allergy remedies market report.