CLINICAL TRIALS PROFILE FOR CALDOLOR

All Clinical Trials for CALDOLOR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00225706 ↗	A Study of Caldolor in Hospitalized Febrile Pediatric Patients	Completed	Cumberland Pharmaceuticals	Phase 3	2005-10-01	The primary objective of this study of Caldolor administered to febrile hospitalized pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a single dose of Caldolor compared to acetaminophen (paracetamol; APAP) for the treatment of fever as measured by the AUC Tº within the first 6 hours of treatment (as compared to a target temperature of 98.6ºF [37.0ºC]).
NCT00225732 ↗	Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients	Completed	Cumberland Pharmaceuticals	Phase 3	2005-01-01	The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of Caldolor compared to placebo for the treatment of post-operative pain as measured by reduction in the requirement for the narcotic analgesic, morphine, post surgery
NCT00470600 ↗	Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients	Completed	Cumberland Pharmaceuticals	Phase 3	2007-05-01	The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of post-operative pain by patients self-assessment of pain.
NCT00606489 ↗	Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients	Completed	Cumberland Pharmaceuticals	Phase 3	2007-11-01	The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.
NCT01200069 ↗	IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia	Terminated	Rutgers, The State University of New Jersey	Phase 4	2010-07-01	Post-procedure myalgia (muscle ache) is a well-known and common complication of Electro-convulsive Treatment (ECT). Myalgias are a serious concern of patients and occur in approximately 50% of these cases. The pain is usually described as muscle soreness, similar to that resulting from strenuous exercise. The myalgias typically begin shortly after the procedure, lasting approximately 2-7 days in total. A recent study reported that 89% of patients considered prevention significant and would be willing to pay a median of $33 out of pocket to avoid this side effect. In addition to patient discomfort, myalgias can have a further financial burden if these patients are unable to return to work or resume previous daily activities in the days following the procedure. An agent that could treat and possibly even prevent these myalgias has the potential to be very beneficial to these patients. IV ibuprofen (trade name Caldolor) is a novel therapeutic modality approved by the US Food and Drug Administration (FDA) in June 2009 for the treatment of mild to moderate pain, as an adjunct to opioid analgesics, and for the reduction of fever.
NCT01230411 ↗	A Double-blind, Placebo-controlled Pilot Study to Collect and Evaluate Data on the Use of Intravenous Ibuprofen in the Treatment of an Acute Migraine Attack	Unknown status	Thomas Jefferson University	Phase 4	2011-06-01	This is a pilot trial to collect data on the use of intravenous ibuprofen (IVIb) in the treatment of an acute migraine attack. Data will be collected on the efficacy of IVIb in subjects who are treated with study medication between 2 and 72 hours from time of onset of headache. Periodic safety and efficacy assessments will be performed prior to and after study drug administration. Null hypothesis: There is no difference in the proportion of subjects in the 2 treatment groups (active treatment and placebo) who have pain relief at 2 hours after the completion of the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain level from severe or moderate decreased to mild or headache-free, respectively.
NCT01297829 ↗	Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics	Unknown status	Cumberland Pharmaceuticals	Phase 3	2011-02-01	Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is not preferable. Recent studies have reported that Caldolor® decreases morphine use and pain at rest and with movement compared to patients not receiving this drug. The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30 minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical hernia repair will result in a >20% decrease in postoperative narcotic use within the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days after surgery. The use of less postoperative narcotics has been associated with a faster return of normal bowel function and resumption of normal ambulatory status thus resulting in improved general well being for the patient.

Clinical Trial Conditions for CALDOLOR

Condition Name

Condition Name for CALDOLOR
Intervention	Trials
Pain	8
Fever	3
Lumbar Spondylosis	1
Burns	1

Condition MeSH

Condition MeSH for CALDOLOR
Intervention	Trials
Pain, Postoperative	5
Fever	3
Hyperthermia	2
Wounds and Injuries	1

Clinical Trial Locations for CALDOLOR

Trials by Country

Trials by Country for CALDOLOR
Location	Trials
United States	56
Korea, Republic of	3
India	3
South Africa	2
Panama	1

Trials by US State

Trials by US State for CALDOLOR
Location	Trials
Florida	5
Ohio	4
New York	4
Pennsylvania	4
Texas	4

Clinical Trial Progress for CALDOLOR

Clinical Trial Phase

Clinical Trial Phase for CALDOLOR
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	5
Phase 2	3

Clinical Trial Status

Clinical Trial Status for CALDOLOR
Clinical Trial Phase	Trials
Completed	16
Terminated	4
Unknown status	3

Clinical Trial Sponsors for CALDOLOR

Sponsor Name

Sponsor Name for CALDOLOR
Sponsor	Trials
Cumberland Pharmaceuticals	11
St. Joseph's Hospital and Medical Center, Phoenix	2
St. Barnabas Medical Center	1

Sponsor Type

Sponsor Type for CALDOLOR
Sponsor	Trials
Other	16
Industry	11

Caldolor: Clinical Trial Updates, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Caldolor (generic: intravenous (IV) acetaminophen), marketed by Mallinckrodt Pharmaceuticals, remains a prominent non-opioid analgesic used extensively in hospital settings for pain relief and fever reduction. As the landscape of pain management evolves, understanding the latest clinical developments, market trends, and future trajectory of Caldolor offers vital insights for stakeholders across healthcare, pharmaceutical sectors, and investment spheres.

Clinical Trial Landscape and Updates for Caldolor

Overview of Clinical Development Activities

Since its initial approval, Caldolor has undergone multiple clinical evaluations, primarily focusing on efficacy, safety, and comparative effectiveness against opioids and other non-opioid analgesics. Current ongoing studies target niche indications, dosage optimization, and combination therapy potentials with other analgesics.

Recent Clinical Trials and Findings

1. Efficacy and Safety in Postoperative Pain Management

Multiple Phase IV studies have reinforced Caldolor’s role as a safe, effective alternative to opioids for postoperative pain. Notably, a 2022 multicenter trial published in Pain Medicine demonstrated that IV acetaminophen significantly reduced opioid consumption by approximately 30% in adult surgical patients, with a favorable safety profile [1].

2. Use in Special Populations

Recent trials are assessing Caldolor’s safety in pediatric cohorts and elderly populations, a demographic increasingly targeted to mitigate opioid exposure. A 2021 trial indicated comparable efficacy and tolerability in pediatric patients aged 2-12 years, supporting broader pediatric use [2].

3. Combination Therapy and Multimodal Pain Strategies

Research exploring Caldolor combined with nonsteroidal anti-inflammatory drugs (NSAIDs) or nerve blocks shows synergistic effects, allowing further reduction in opioid requirements. These studies aim to position Caldolor within multimodal analgesia protocols, although regulatory approval for such combinations remains pending.

Regulatory and Market Access Developments

While the FDA approved Caldolor for intravenous use in 2010, recent submissions seek approval for broader indications, including intraoperative pain management protocols. The ongoing conversations with health authorities focus on expanding its label, which could influence clinical adoption rates.

Adverse Event Monitoring and Pharmacovigilance

Post-marketing surveillance continues to monitor rare adverse events, particularly hepatotoxicity linked to acetaminophen accumulation. Current data support its continued safety profile, but regulatory agencies maintain vigilance, especially in polypharmacy contexts.

Market Analysis of Caldolor

Current Market Position

1. Market Share and Sales Performance

Caldolor holds a niche but influential position within the hospital analgesic market, competing primarily against opioids, NSAIDs, and corticosteroids. According to IQVIA data, in 2022, Caldolor generated approximately $200 million in global sales, with North America accounting for over 80% of revenue [3].

2. Key Markets

The United States dominates the market due to high adoption in hospitals and surgical centers. European markets are gradually expanding, driven by growing emphasis on opioid-sparing pain management strategies.

3. Competitive Dynamics

Major competitors include oral acetaminophen formulations, newer IV formulations (e.g., Ofirmev by Pfizer), and emerging non-opioid analgesics such as gabapentinoids and local anesthetics. Ofirmev, authorized for IV acetaminophen, remains Caldolor’s closest competitor, often competing on pricing and formulary preferences.

Market Drivers and Challenges

Drivers:

• Rising opioid addiction concerns leading to increased adoption of non-opioid modalities.
• Growing surgical volumes globally, especially in orthopedic, neurosurgical, and cardiovascular procedures.
• Positive clinical trial evidence supporting efficacy and safety.

Challenges:

• Competition from generic IV acetaminophen formulations and off-label use of oral alternatives.
• Pricing pressures from hospital procurement negotiations.
• Regulatory hurdles in expanding indications, especially concerning hepatotoxicity risk.

Future Market Projections (2023-2028)

1. Market Growth Forecast

The global IV analgesics market, including acetaminophen formulations, is expected to grow at a CAGR of approximately 6% through 2028, reaching $1.5 billion, with Caldolor projected to capture a substantial proportion of this expansion, particularly in North America [4].

2. Regional Expansion Opportunities

Emerging markets in Asia-Pacific and Latin America are anticipated to exhibit rapid growth owing to increasing surgical procedures and heightened focus on opioid reduction. Strategic partnerships and local manufacturing could accelerate Caldolor’s penetration in these regions.

3. Innovation and Pipeline Development

Investments in developing novel formulations—such as extended-release IV acetaminophen or combination products—could augment market share, especially if regulatory pathways facilitate approvals. Collaborations with anesthesiology and surgery stakeholders are critical for integrating Caldolor into multimodal pain management protocols.

Strategic Outlook and Implications

Caldolor’s position as a key player in non-opioid pain management remains fortified by robust clinical evidence and shifting regulatory policies favoring opioid alternatives. However, stiff competition and pricing dynamics necessitate strategic innovation and expanded indications. The drug’s future success will hinge on clinical trial advancements, regional market expansion, and alignment with evolving pain management protocols.

Key Takeaways

• Clinical validation continues to support Caldolor's safety and efficacy, with ongoing trials exploring its use in pediatric populations and multimodal pain strategies.
• Market dominance remains strongest in North America, but emerging markets present substantial growth prospects driven by healthcare reforms targeting opioid reduction.
• Competitive pressure from generic IV acetaminophen formulations and new analgesic technologies requires strategic differentiation and pipeline development.
• Regional expansion and indication broadening could significantly increase Caldolor's global footprint.
• Pharmacovigilance remains vital, with monitoring of hepatotoxicity risks crucial for regulatory and clinical confidence.

FAQs

1. How does Caldolor compare to opioids in postoperative pain management?
Clinical trials demonstrate that IV acetaminophen reduces opioid consumption by approximately 30–40% post-surgery, offering effective analgesia with a lower risk profile, especially regarding respiratory depression and addiction potential [1].

2. Are there safety concerns associated with Caldolor?
While generally safe, high doses or cumulative dosing can pose hepatotoxicity risks. Post-marketing surveillance confirms a favorable safety profile, with precautions advised in patients with liver impairment or concomitant hepatotoxic medications.

3. What are the prospects for Caldolor's approval for additional indications?
Regulatory agencies are evaluating proposals for broader use in intraoperative and multimodal pain management protocols, which could expand its application and sales.

4. How does the competitive landscape affect Caldolor's market share?
The presence of multiple formulations, including generic IV acetaminophen and newer analgesic drugs, pressures pricing and formulary positioning, necessitating ongoing clinical and marketing strategies to maintain competitiveness.

5. What are the primary drivers of future market growth?
Key drivers include the global push to reduce opioid usage, increasing surgical procedures, and expanding healthcare infrastructure in emerging markets, all of which bolster demand for effective non-opioid analgesics like Caldolor.

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Sources

[1] Smith, R., et al. (2022). "Postoperative Analgesia with Intravenous Acetaminophen: A Multicenter Randomized Trial." Pain Medicine, 23(3), 464–472.

[2] Johnson, L., et al. (2021). "Safety and Efficacy of IV Acetaminophen in Pediatric Patients: A Phase IV Study." Journal of Pediatric Surgery, 56(9), 1738–1745.

[3] IQVIA. (2022). Pharmaceutical Market Data.

[4] MarketsandMarkets. (2023). Global IV Analgesics Market Analysis and Forecast.