CLINICAL TRIALS PROFILE FOR EPHEDRINE SULFATE

All Clinical Trials for EPHEDRINE SULFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00426842 ↗	A Dose Response Trial Using 5 and 10 Mg of Midodrine Hydrochloride	Completed	James J. Peters Veterans Affairs Medical Center	Phase 2	2007-01-01	With upright postures, there is an immediate redistribution of blood to the dependent circulation; venous return and central venous filling pressure are reduced, resulting in diminution of cardiac output and blood pressure. These hemodynamic alterations stimulate the baroreceptor reflex, which is mediated via the central nervous system to increase peripheral sympathetic vasomotor tone, restoring blood pressure and cardiac output within seconds-to-minutes of the assumption of the upright position. Following SCI, individuals often experience the inability to adjust to postural changes due to disruption of central command of the baroreceptor reflex and reduction in efferent sympathetic neural pathways; consequently, orthostatic hypotension (OH) and symptoms of cerebral hypo-perfusion may ensue. OH is a well-documented phenomenon, which is characterized by a fall in systolic blood pressure of >20 mmHg or diastolic BP of > 10 mmHg within 3 minutes of assumption of an upright posture. As a consequence of OH, many individuals experience symptoms of cerebral hypo-perfusion which include lightheadedness, dizziness, blurry vision, fatigue, nausea, ringing in the ears, cognitive impairment and heart palpitations. Although several investigators have reported increased prevalence of OH during the acute phase of spinal cord injury (SCI), individuals with chronic injury also experience significant falls in blood pressure with seated upright postures. This investigation will examine the effects of an alpha-agonist, midodrine hydrochloride, during head-up tilt on systemic blood pressure, cerebral blood flow and cerebral oxygenation compared to placebo administration in persons with chronic SCI who demonstrate significant orthostatic hypotension during a 24-hour observation study. This is the first study to determine the dose response and efficacy of midodrine to improve orthostatic blood pressure and cerebral blood flow and oxygenation in the SCI population.
NCT00458003 ↗	Phenylephrine in Spinal Anesthesia in Preeclamptic Patients	Completed	Northwestern University	N/A	2006-07-01	Hypotension remains a common clinical problem after induction of spinal anesthesia for cesarean delivery. Maternal hypotension has been associated with considerable morbidity (maternal nausea and vomiting and fetal/neonatal acidemia). Traditionally, ephedrine has been the vasopressor of choice because of concerns about phenylephrine's potential adverse effect on uterine blood flow. This practice was based on animal studies which showed that ephedrine maintained cardiac output and uterine blood flow, while direct acting vasoconstrictors, e.g., phenylephrine, decreased uteroplacental perfusion. However, several recent studies have demonstrated that phenylephrine has similar efficacy to ephedrine for preventing and treating hypotension and may be associated with a lower incidence of fetal acidosis. All of these studies have been performed in healthy patients undergoing elective cesarean delivery. Preeclampsia complicates 5-6% of all pregnancies and is a significant contributor to maternal and fetal morbidity and mortality. Many preeclamptic patients require cesarean delivery of the infant. These patients often have uteroplacental insufficiency. Given the potential for significant hypotension after spinal anesthesia and its effect on an already compromised fetus, prevention of (relative) hypotension in preeclamptic patients is important. Spinal anesthesia in preeclamptic patients has been shown to have no adverse neonatal outcomes as compared to epidural anesthesia when hypotension is treated adequately. Due to problems related to management of the difficult airway and coagulopathy, both of which are more common in preeclamptic women, spinal anesthesia may be the preferred regional anesthesia technique. Recent studies have demonstrated that preeclamptic patients may experience less hypotension after spinal anesthesia than their healthy counterparts. To our knowledge, phenylephrine for the treatment of spinal anesthesia-induced hypotension has not been studied in women with preeclampsia. The aim of our study is to compare intravenous infusion regimens of phenylephrine versus ephedrine for the treatment of spinal anesthesia induced hypotension in preeclamptic patients undergoing cesarean delivery. The primary outcome variable is umbilical artery pH.
NCT01006863 ↗	Preoperative Ephedrine Attenuates the Hemodynamic Responses of Propofol During Valve Surgery: A Dose Dependent Study	Completed	Mansoura University	Phase 2	2004-03-01	The prophylactic use of small doses of ephedrine may be effective in obtunding of the hypotension responses to propofol with minimal hemodynamic and ST segment changes. The investigators aimed to evaluate the effects of small doses of ephedrine on hemodynamic responses of propofol anesthesia for valve surgery. There is widespread interest in the use of propofol for the induction and maintenance of anesthesia for fast track cardiac surgery. However, its use for induction of anesthesia is often associated with a significant rate related transient hypotension for 5-10 minutes. This is mainly mediated with decrease in sympathetic activity with minor contribution of its direct vascular smooth muscle relaxation and direct negative inotropic effects. Ephedrine has demonstrated as a vasopressor drug for the treatment of hypotension in association with spinal and general anesthesia. Prophylactic use of high doses of ephedrine [10-30 mg] was effective in obtunding the hypotensive response to propofol with associated marked tachycardia. However, the use of smaller doses (0.1-0.2 mg/kg) was successfully attenuated, but not abolished, the decrease in blood pressure with transient increase in heart rate. This vasopressor effect is mostly mediated by β-stimulation rather than α-stimulation and also indirectly by releasing endogenous norepinephrine from sympathetic nerves. Because the effect of decreasing the dose of ephedrine from 0.1 to 0.07 mg/kg may be clinically insignificant, the investigators postulated that the prophylactic use of small dose of ephedrine may prevent propofol-induced hypotension after induction of anesthesia for valve surgery with minimal in hemodynamic, ST segment, and troponin I changes. The aim of the present study was to investigate the effects of pre-induction administration of 0.07, 0.1, 0.15 mg/kg of ephedrine on heart rate (HR), mean arterial blood pressure (MAP), central venous and pulmonary artery occlusion pressures (CVP and PAOP, respectively), cardiac (CI), stroke volume (SVI), systemic and pulmonary vascular resistance (SVRI and PVRI, respectively), left and right ventricular stroke work (LVSWI and RVSWI, respectively) indices, ST segment, and cardiac troponin I (cTnI) changes in the patients anesthetized with propofol-fentanyl for valve surgery.
NCT01006863 ↗	Preoperative Ephedrine Attenuates the Hemodynamic Responses of Propofol During Valve Surgery: A Dose Dependent Study	Completed	King Faisal University	Phase 2	2004-03-01	The prophylactic use of small doses of ephedrine may be effective in obtunding of the hypotension responses to propofol with minimal hemodynamic and ST segment changes. The investigators aimed to evaluate the effects of small doses of ephedrine on hemodynamic responses of propofol anesthesia for valve surgery. There is widespread interest in the use of propofol for the induction and maintenance of anesthesia for fast track cardiac surgery. However, its use for induction of anesthesia is often associated with a significant rate related transient hypotension for 5-10 minutes. This is mainly mediated with decrease in sympathetic activity with minor contribution of its direct vascular smooth muscle relaxation and direct negative inotropic effects. Ephedrine has demonstrated as a vasopressor drug for the treatment of hypotension in association with spinal and general anesthesia. Prophylactic use of high doses of ephedrine [10-30 mg] was effective in obtunding the hypotensive response to propofol with associated marked tachycardia. However, the use of smaller doses (0.1-0.2 mg/kg) was successfully attenuated, but not abolished, the decrease in blood pressure with transient increase in heart rate. This vasopressor effect is mostly mediated by β-stimulation rather than α-stimulation and also indirectly by releasing endogenous norepinephrine from sympathetic nerves. Because the effect of decreasing the dose of ephedrine from 0.1 to 0.07 mg/kg may be clinically insignificant, the investigators postulated that the prophylactic use of small dose of ephedrine may prevent propofol-induced hypotension after induction of anesthesia for valve surgery with minimal in hemodynamic, ST segment, and troponin I changes. The aim of the present study was to investigate the effects of pre-induction administration of 0.07, 0.1, 0.15 mg/kg of ephedrine on heart rate (HR), mean arterial blood pressure (MAP), central venous and pulmonary artery occlusion pressures (CVP and PAOP, respectively), cardiac (CI), stroke volume (SVI), systemic and pulmonary vascular resistance (SVRI and PVRI, respectively), left and right ventricular stroke work (LVSWI and RVSWI, respectively) indices, ST segment, and cardiac troponin I (cTnI) changes in the patients anesthetized with propofol-fentanyl for valve surgery.
NCT02033629 ↗	Low Remifentanil Target Controlled Infusions for Cardiac Surgery	Completed	Dammam University	Phase 3	2014-05-01	The development of target effect-site controlled concentrations (TCI) of remifentanil have gained increasing acceptance during cardiac surgery as regarding the resulting of hemodynamic stability and early extubation. The use of low-dose opioid technique has been progressively used nowadays because of its ceiling effect to attenuate cardiovascular responses to noxious stimuli. We hypothesize that the use of low target remifentanil effect site concentrations may provide comparable shorter times to tracheal extubation and hemodynamic stability to the use of high remifentanil Ce during target-controlled propofol anesthesia for cardiac surgery.
NCT02296333 ↗	Ondansetron's Opposite Effect on Postoperative Analgesia of Acetaminophen	Completed	Mustafa Kemal University	Phase 4	2014-05-01	The purpose of the study is to determine whether the effect of ondansetron on the analgesic effect of acetaminophen. Because 5HT3 blockers prevent the analgesic effects of acetaminophen and also reduce opioid consumption
NCT03587441 ↗	Intrathecal Neostigmine for Prevention of PDPH	Completed	Fayoum University Hospital	Phase 4	2018-08-04	Neuraxial blocks continue to be the cornerstone of anesthesia and postoperative analgesia for normal vaginal delivery and elective caesarean section due to its approved safety and efficiency for decades. Post-dural puncture headache (PDPH) is still one of the most common complications of neuraxial anesthetic techniques. The headache could be severe and limit the activities of the new mother to care for her baby, prolong hospital stay. PDPH is defined as a headache that develops within five days of dural puncture and can't be attributed to any other types of headache and mostly is postural in character. Neostigmine methylsulfate is a synthetic carbamic acid ester which reversibly inhibits the enzyme Acetylcholine esterase (AChE) that makes more Acetylcholine molecules available at cholinergic receptors. Neostigmine is used in anesthesia mainly as a reversal for non-depolarizing neuromuscular agents. Intrathecal (IT) neostigmine was tried as an adjuvant to local anesthetics in IT block for elective cesarean sections to decrease local anesthetic consumption and to prolong postoperative analgesia. Side effects of IT neostigmine are dose-dependent with doses more than 25 µg especially nausea and vomiting and could be decreased by increasing the baricities of the local anesthetic solutions and by early head up position after IT injection. However, its effect on PDPH was not investigated before in literature. Parturients will be randomly assigned into one of two groups: the intervention group will receive 20 µg with IT Bupivacaine and the control group will receive an equivalent volume of dextrose 5% with the IT Bupivacaine. The objective of the current study is to evaluate the efficacy and safety of IT neostigmine as an adjuvant to bupivacaine in reducing the incidence and severity of post-dural puncture headache in parturients scheduled for an elective cesarean section.

Clinical Trial Conditions for EPHEDRINE SULFATE

Condition Name

Condition Name for EPHEDRINE SULFATE
Intervention	Trials
Hypotension	2
Pain, Postoperative	2
General Surgery	1
Pain	1

Condition MeSH

Condition MeSH for EPHEDRINE SULFATE
Intervention	Trials
Pain, Postoperative	4
Hypotension	3
Headache	1
Obesity	1

Clinical Trial Locations for EPHEDRINE SULFATE

Trials by Country

Trials by Country for EPHEDRINE SULFATE
Location	Trials
Egypt	7
Saudi Arabia	2
United States	2
Mexico	1
China	1

Trials by US State

Trials by US State for EPHEDRINE SULFATE
Location	Trials
Illinois	1
New York	1

Clinical Trial Progress for EPHEDRINE SULFATE

Clinical Trial Phase

Clinical Trial Phase for EPHEDRINE SULFATE
Clinical Trial Phase	Trials
PHASE4	1
PHASE1	1
Phase 4	6

Clinical Trial Status

Clinical Trial Status for EPHEDRINE SULFATE
Clinical Trial Phase	Trials
Completed	13
Not yet recruiting	2
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for EPHEDRINE SULFATE

Sponsor Name

Sponsor Name for EPHEDRINE SULFATE
Sponsor	Trials
Ain Shams University	2
Mansoura University	2
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders	1

Sponsor Type

Sponsor Type for EPHEDRINE SULFATE
Sponsor	Trials
Other	18
U.S. Fed	1

Last updated: July 23, 2026

Ephedrine Sulfate Clinical Trials Update, Market Analysis, and Future Revenue Projections (2026-2035)

What clinical trials exist for ephedrine sulfate and what is the latest update?

No current, reliably verifiable global clinical-trial activity summary (phase status, enrollment, primary endpoints, completion dates) can be produced to a litigation-grade standard for ephedrine sulfate without access to a complete, up-to-date trial registry snapshot.

Key limitation preventing a complete update: Ephedrine sulfate is an older, widely used sympathomimetic with multiple route-specific and indication-specific uses, and the clinical evidence base is fragmented across national registries, older studies, and historical pharmacology programs. A single consolidated “latest update” cannot be stated accurately from the information available here.

Which trial types are most likely to include ephedrine sulfate?

• Anesthesia support (hypotension/vasopressor-sparing strategies)
• Bronchospasm or upper airway symptom contexts (often older evidence)
• Cold symptom/respiratory combination products (where the active component may be ephedrine or salts of ephedrine)
• Sympathomimetic pharmacokinetics or formulation work (including salt-form stability and dose-response)

How big is the ephedrine sulfate market today and what drives demand?

A precise market sizing statement (global $ or unit volumes) and a forward-looking projection cannot be produced to the required standard without a defined scope (API vs finished dosage forms, geographies, and whether the analysis includes ephedrine-containing combination products).

Key limitation preventing a complete market model: “Ephedrine sulfate” is used across multiple commercial constructs. Many market datasets track ephedrine (base) or “ephedrine alkaloids” rather than the sulfate salt specifically, and sales records often embed ephedrine sulfate into combination cold/respiratory products or into anesthesia-related procurement channels that are not consistently labeled by salt form.

Demand drivers that typically matter

• Perioperative use patterns (anesthesia protocols and formulary preferences)
• Regulatory enforcement and controls affecting supply chains
• Availability of alternatives (other vasopressors and bronchodilator regimens)
• Shifts in manufacturing capacity and sourcing of ephedrine alkaloids
• Formulation preferences (oral vs injectable and specialty compounding)

When does ephedrine sulfate face generic entry risk and patent barriers?

Ephedrine sulfate is a legacy small-molecule with long commercial history. Patent estates, where present, are typically formulation, process, or method-of-use specific rather than covering the core API indefinitely. Without a specific reference product, manufacturer, and jurisdictional patent dossier, no quantified “patent strength” or generic entry risk can be asserted.

What usually creates IP around ephedrine sulfate

• Injectable formulation stability and preservative systems
• Salt form or particle/solvate-related process claims (where applicable)
• Patient-use method-of-use claims (rare in modern practice for legacy drugs)
• Manufacturing processes for API purification and crystallization

What does FDA status look like for ephedrine sulfate (Orange Book, exclusivities, approvals)?

A complete FDA regulatory status and Orange Book mapping cannot be provided here to an actionable standard because it requires product-specific identification in the FDA Orange Book and alignment to a specific NDA/ANDA entry or reference listed drug (RLD). Ephedrine sulfate exists in multiple dosage forms and may be sold under different approved applications.

What the FDA status generally depends on

• Product application type (NDA, ANDA, or compounding-based market supply)
• Route (oral vs injection) and strength
• Whether the marketed product is an RLD with an Orange Book listing
• Exclusivity attached to the specific approval, not the active ingredient

How do competitors and substitutes affect ephedrine sulfate pricing and growth?

A defensible market competitive analysis (substitution map and market share projection) cannot be produced without a clearly bounded product universe and verified baseline volumes by route and indication. In practice, substitution risk varies sharply by use case.

Substitute categories that typically pressure ephedrine sulfate

• For hypotension in perioperative settings: phenylephrine, norepinephrine, ephedrine alternatives depending on protocol
• For respiratory symptoms: other bronchodilators and combination approaches
• For cold/upper-respiratory symptoms: decongestant/antitussive combinations and regulatory-driven formulation shifts

What is the expected revenue trajectory for ephedrine sulfate in the next decade?

A numerical projection from 2026 to 2035 cannot be stated accurately without:

• a baseline market size by geography and route
• verified pricing/volume history for ephedrine sulfate (not just ephedrine alkaloids)
• assumptions on regulatory constraints and capacity utilization
• an Orange Book and patent/filing barrier map tied to specific FDA-approved products

Which formulation patents could matter most for ephedrine sulfate products?

Patent protection, where relevant, typically clusters around:

• injectable formulation stability
• preservatives and antioxidant systems
• concentration/volume combinations for specific labeled use
• manufacturing controls for API salt crystallization

A specific list of protecting patents and expiration dates cannot be produced without a defined reference product and identified patent family records.

What litigation or Paragraph IV challenges exist for ephedrine sulfate?

No litigation dataset can be asserted reliably here without product identifiers and jurisdiction-specific case retrieval. For legacy active ingredients, disputes may center on formulation or manufacturing claims, and cases may not be labeled in public sources using “ephedrine sulfate” consistently.

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Key Takeaways

• A complete, investment-grade clinical trials update for ephedrine sulfate cannot be produced from the information available here without a current trial-registry snapshot mapped to specific indications, phases, and endpoints.
• Market sizing and 2026-2035 revenue projections cannot be stated accurately without a bounded scope (API vs finished dosage forms, route, geography, inclusion of combination products) and verified pricing/volume baselines.
• FDA Orange Book status, exclusivities, and patent expiration timelines require product-specific identification; the active ingredient alone is not sufficient for a correct, actionable map.
• IP and generic-entry risk for ephedrine sulfate typically center on formulation/process rather than long-lived API exclusivity, but the specific patent lists cannot be enumerated without a defined reference product dossier.

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FAQs

Is ephedrine sulfate still used in anesthesia today?

Yes, ephedrine has long-standing use patterns in perioperative care, but current utilization and protocol preferences vary by country and formulary. A current, quantified global utilization map requires route- and facility-level procurement data.

Are there ongoing trials for ephedrine sulfate in respiratory indications?

Some studies exist historically across respiratory contexts and pharmacology work, but a current “latest trial update” requires registry-confirmed phase and timeline details.

Does ephedrine sulfate have Orange Book exclusivity?

Orange Book exclusivity attaches to specific FDA-approved products (application entries), not the salt as a standalone concept. The presence and type of exclusivity depends on the particular NDA/ANDA/RLD.

What are the main manufacturing and supply-chain constraints for ephedrine sulfate?

Supply constraints typically relate to controlled precursor sourcing, conversion and purification capacity, and compliance requirements affecting procurement and distribution.

How does ephedrine sulfate compare with phenylephrine or norepinephrine for hypotension treatment?

Clinical practice differs by setting and protocol. Choice depends on patient characteristics, hemodynamic targets, and institutional standards rather than a uniform superiority claim across all contexts.