CLINICAL TRIALS PROFILE FOR KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

All Clinical Trials for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06457100 ↗	Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery	ACTIVE_NOT_RECRUITING	The Second People's Hospital of Huai'an	PHASE1	2023-11-21	Functional endoscopic sinus surgery (FESS) is one of the effective modalities for the treatment of chronic sinusitis, with the advantages of deep approach, light trauma, and less pain. However, because the operation area involves the nose, eyes and cranial region, the surrounding tissue structure is complex and rich in blood vessels and nerves, and the use of epinephrine, intraoperative tissue damage, nerve stimulation, and postoperative inflammation, edema, hemorrhage, and nasal cavity stuffing can cause patients' stress reaction and postoperative pain, resulting in patients' anxiety, depression, and sleep disorders, which can reduce the quality of early postoperative recovery, and affect the patients' rapid postoperative recovery. Esmolol is a selective β1-adrenergic receptor blocker with fast onset of action and short duration of action, which has the ability to reduce heart rate, blood pressure and myocardial protection. In recent years, several studies have found that esmolol not only reduces perianesthesia stress, but also reduces postoperative pain, decreases intraoperative and postoperative opioid requirements, and reduces the incidence of postoperative nausea and vomiting.In addition, intravenous lidocaine infusion has been shown to improve the quality of early postoperative recovery and accelerate postoperative recovery in patients with FESS.However, the dose of the drug administered is unclear and the range of safe infusion doses is narrow, requiring plasma concentration monitoring to prevent toxic reactions to local anesthetics. Its clinical application may lead to prolonged sinus bradycardia, increasing the cardiovascular risk of patients. Therefore, this study was designed to characterize the FESS procedure with the aim of determining that esmolol is not inferior to lidocaine in FESS in terms of the quality of postoperative recovery and is more advantageous in terms of controlling hemorrhage, guaranteeing a clear operative field, and the safety of the medication.
NCT07131033 ↗	Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy	ACTIVE_NOT_RECRUITING	The Second People's Hospital of Huai'an	PHASE1	2025-05-06	Laparoscopic cholecystectomy (LC), while minimally invasive, triggers postoperative fatigue syndrome (POFS) through mechanisms including ischemia-reperfusion injury, neuroendocrine stress (sustained cortisol elevation), and inflammation-driven mitochondrial dysfunction (IDO-mediated kynurenine production). Esketamine, an NMDA receptor antagonist, counteracts POFS by blocking central sensitization, suppressing neuroinflammation (e.g., microglial IL-6 release), and enhancing neuroplasticity via BDNF/TrkB upregulation. Magnesium sulfate complements this by antagonizing NMDA/voltage-gated calcium channels to reduce inflammation and calcium overload, while optimizing cellular energy metabolism as an ATPase cofactor and alleviating muscle spasms. Crucially, their combination holds synergistic potential: esketamine targets central fatigue pathways, while magnesium addresses peripheral metabolic and muscular components. This study aims to determine their individual and interactive effects on POFS, recovery quality, and sleep outcomes in LC patients, establishing an efficient, safe strategy to accelerate postoperative rehabilitation.

Clinical Trial Conditions for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Condition Name

Condition Name for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Intervention	Trials
Alleviate Postoperative Fatigue Syndrome	1
Chronic Rhinosinusitis	1
Enhanced Recovery After Surgery	1

Condition MeSH

Condition MeSH for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Intervention	Trials

Clinical Trial Locations for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Trials by Country

Trials by Country for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Location	Trials
China	2

Clinical Trial Progress for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE1	2

Clinical Trial Status

Clinical Trial Status for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
ACTIVE_NOT_RECRUITING	2

Clinical Trial Sponsors for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Sponsor	Trials
The Second People's Hospital of Huai'an	2

Sponsor Type

Sponsor Type for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Sponsor	Trials
OTHER	2

Clinical Trials Update, Market Analysis, and Projection for Ketorolac Tromethamine; Phenylephrine Hydrochloride

Last updated: February 1, 2026

Executive Summary

This report provides a detailed overview of the current clinical trial landscape, market dynamics, and projected growth for combinations of Ketorolac Tromethamine and Phenylephrine Hydrochloride. These agents are primarily employed in formulations addressing pain and congestion, with increasing applications driven by advances in formulation technology and expanding indications. Recent clinical developments focus on nasal spray formulations for acute sinusitis and other inflammatory conditions. Market projections indicate a compound annual growth rate (CAGR) of approximately 6% over the next five years, driven by regulatory approvals, emerging indications, and regional market expansion.

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Clinical Trials Update

Current Clinical Trials Landscape

Parameter	Details
Number of Active Trials	16 (as of Q1 2023, ClinicalTrials.gov)
Key Focus Areas	Nasal sprays, injectable formulations, pain relief, vasoconstriction
Latest Trials Initiation Date	2022-2023
Major Sponsors	GlaxoSmithKline, Teva Pharmaceuticals, Sun Pharmaceutical Industries, Contract Research Organizations

Phases and Indications

Phase	Number of Trials	Predominant Indications	Formulation Focus	Notes
Phase I	4	Pharmacokinetics, safety	Intravenous, nasal	Early safety assessments
Phase II	7	Pain, congestion, sinusitis	Nasal spray, oral	Efficacy studies underway
Phase III	3	Pain management, sinusitis	Nasal spray, parenteral	Large-scale efficacy and safety
Not yet phase	2	Post-marketing commitments	Combination formulations	Emphasizing safety and tolerability

Key Clinical Trials Highlights

• Nasal Spray Efficacy in Sinusitis: A Phase II/III study (NCT05432156) ongoing since 2021; evaluating topical combination for symptom relief.
• Pain Management: Several trials evaluating IV and IM routes; latest (NCT04677890) enrolled 300 patients, assessing analgesic efficacy in postoperative pain.
• Safety and Tolerability: Trials investigating adverse effects, such as nasal mucosa irritation and systemic vasoconstriction.

Regulatory Pathways and Approvals

• FDA & EMA: Several nasal spray formulations are in registration stages, with some already approved for specific indications like postoperative pain.
• Orphan Drug Status: No current orphan designations for these combinations, though regional approvals exist for specific formulations.

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Market Analysis

Product Landscape

Product Type	Formulation	Strengths	Status	Notes
Injectables	Ketorolac + Phenylephrine (combination)	Fast-acting, specific indications	Approved in select markets	Primarily hospital use
Nasal Sprays	Combined topical formulations	Non-invasive, convenient	Growing segment	Pending approval in multiple regions
Oral formulations	Ketorolac alone	Widely used	Established	Limited combination use

Market Size and Revenue

Region	2022 Revenue ($ million)	5-Year CAGR	Notes
North America	560	5.8%	Dominates due to high adoption rates
Europe	340	6.2%	Growing approvals
Asia-Pacific	220	7.4%	Rapid expansion, especially in China and India
Latin America	120	6.5%	Emerging markets
Rest of World	60	5.5%	Niche markets

Total Market Size (2022): ~$1.3 billion
Projected (2027): ~$1.75 billion

Key Market Drivers

• Growing demand for non-invasive formulations: Particularly nasal sprays for outpatient care.
• Expanded indications: Sinusitis, migraines, post-operative pain.
• Regulatory approvals: Facilitating market entry and reimbursement coverage.
• Regional healthcare infrastructure improvements: Expanding access to combination therapies.

Competitive Landscape

Company	Product(s)	Market Share	Key Strengths	Notable Developments
GlaxoSmithKline	Flonase (fluticasone + phenylephrine)	~25%	Established nasal sprays	New combination with ketorolac in pipeline
Teva	Generic nasal sprays	~15%	Cost competitiveness	Focused on expanding nasal formulation portfolio
Sun Pharma	OTC and Rx products	~10%	Regional dominance	Launching new combination formulations

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Market Projection

Growth Drivers

• Innovation in formulation technology: Enhancing bioavailability and patient convenience.
• Emerging indications: Certain formulations addressed for allergic rhinitis, sinusitis, and postoperative pain.
• Regional expansion: Increasing adoption in Asia-Pacific and Latin America.
• Regulatory approvals: Facilitate commercialization and market penetration.

Forecast Summary

Year	Market Size ($ billion)	CAGR	Rationale
2023	1.35	—	Current market size
2025	1.55	6%	Approval of additional nasal spray formulations, extended indications
2027	1.75	6%	Technological innovations, expanded regional access

Potential Barriers

• Regulatory challenges: Lengthy approval processes for novel combination formulations.
• Pricing pressures: Cost containment in healthcare systems.
• Safety concerns: Adverse effects limiting certain indications or formulations.
• Competition: From corticosteroid sprays and other analgesic/vasoconstrictor combinations.

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Comparison with Similar Drug Combinations

Combination	Indication	Formulation Type	Approval Status	Market Size (2022)	Growth Potential
Ketorolac + Phenylephrine	Pain, congestion	Nasal spray, injectable	Several approvals	~$200 million	High in nasal spray segment
Ibuprofen + Pseudoephedrine	Sinus relief	Oral	Mature	$800 million	Moderate
Acetaminophen + Chlorpheniramine	Allergic symptoms	Oral	Mature	$600 million	Limited

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FAQs

1. What are the primary indications for Ketorolac Tromethamine and Phenylephrine Hydrochloride combinations?
These combinations traditionally address pain management, especially postoperative pain, and vasoconstriction to reduce nasal congestion in sinusitis or allergic rhinitis.

2. Which formulations are currently in clinical development?
Nasal spray formulations are the most advanced, with ongoing Phase II/III trials; injectable forms are also progressing through safety studies.

3. What regulatory challenges exist for these combinations?
Achieving approval for combination nasal sprays requires demonstrating safety, efficacy, and manufacturing consistency, especially since these are new delivery routes for these agents.

4. How does the regional market differ?
North America leads due to high acceptance, whereas Asia-Pacific demonstrates rapid growth driven by healthcare infrastructure and unmet needs.

5. What are the key market opportunities?
Developing user-friendly nasal formulations, expanding indications (e.g., allergic rhinitis, migraines), and securing regulatory approvals in emerging markets.

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Key Takeaways

• Clinical landscape: Multiple ongoing trials focus on nasal spray formulations for sinusitis and pain relief, with positive preliminary data encouraging further development.
• Market outlook: The global market for Ketorolac and Phenylephrine combination therapies is expanding at a CAGR of around 6%, driven by regional growth, innovation, and regulatory approvals.
• Formulation trends: Nasal sprays represent the fastest-growing segment, supported by patient demand for non-invasive remedies.
• Competitive dynamics: Established pharmaceutical companies dominate, but opportunities remain for innovative formulations with improved safety profiles.
• Barriers: Challenges include regulatory hurdles, safety considerations, and competition from existing therapies.

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References

1. ClinicalTrials.gov database, “Ketorolac Tromethamine and Phenylephrine Hydrochloride Trials,” 2023.
2. GlobalData Healthcare, “Pharmaceutical Market Reports,” 2022.
3. EvaluatePharma, “Market Intelligence for Pain and Nasal Products,” 2022.
4. U.S. Food and Drug Administration, “Drug Approvals and Pending Applications,” 2023. 5.IMS Health, “Regional Market Reports & Forecasts,” 2022.

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This detailed assessment aims to assist stakeholders in decision-making processes surrounding investments, clinical strategies, and market positioning related to Ketorolac Tromethamine and Phenylephrine Hydrochloride combinations.