CLINICAL TRIALS PROFILE FOR NUPRIN

505(b)(2) Clinical Trials for NUPRIN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00011063 ↗	Effect of Ginkgo Biloba on Phenytoin Elimination	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	2001-02-01	This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and overall feeling of well being. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between ginkgo biloba and other medications. This study will look at how ginkgo biloba affects the elimination of phenytoin-a medication used to treat patients with seizures. Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age must use a reliable form of birth control other than oral contraceptives ("the pill"). For at least 2 weeks before the study and throughout its duration, study participants may not have any of the following: 1) medications that can affect platelet function (e.g., aspirin, Motrin, Advil, Nuprin, ibuprofen, etc.); 2) alcoholic beverages; 3) grapefruit and grapefruit juice; and 4) all medications except those given by study personnel. On day 1 of the study, subjects take one 500-mg dose of phenytoin at 8:00 A.M.. On an empty stomach. (Subjects fast the night before taking the phenytoin and are allowed to eat breakfast 2 hours after the dose). Blood samples are drawn just before dosing and again at 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72 and 96 hours after the dose. Blood drawn on this first study day is collected through a catheter (small plastic tube) placed in a vein to avoid multiple needlesticks. After the 12-hour sample is collected, the subject goes home and then returns to the clinic for the remaining blood draws, which are taken by direct needlestick. When the blood sampling is completed, subjects begin ginkgo therapy. The NIH Clinical Center provides participants a supply of 60-mg capsules of ginkgo to take twice a day (at 8 A.M. and 8 P.M..) for 4 weeks. At the end of the 4 weeks, subjects are given a second dose of phenytoin as described above and repeat the blood sampling procedure. Subjects continue taking ginkgo during this second phenytoin study.

All Clinical Trials for NUPRIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006299 ↗	Celebrex for Pain Relief After Oral Surgery	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1999-12-01	This study will evaluate the effects of the new anti-inflammatory drug, Celebrex, on relieving pain after oral surgery. It is also designed to assess the drug's selective inhibition of a chemical called cyclooxygenase-2 and not its closely related form, cyclooxygenase-1. This selective inhibition allows pain alleviation without the adverse side effects (e.g., bleeding and stomach upset) often associated with anti-inflammatory drugs. Healthy volunteers who require removal of their third molars are eligible for this study. Participants will have oral surgery for tooth extraction after receiving a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. On the evening before and 1 hour before surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or Celebrex, or a placebo (a pill with no active ingredient). After surgery, a small piece of tubing will be placed in each extraction site and tied to an adjacent tooth to hold it in place. Samples will be collected from the tubing to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for up to 6 hours after surgery while the anesthetic wears off and will complete pain questionnaires. During that time, they may receive acetaminophen plus codeine (Tylenol 3), if needed, for pain. The tubing then will be removed and the patient discharged with standard pain medication.
NCT00011063 ↗	Effect of Ginkgo Biloba on Phenytoin Elimination	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	2001-02-01	This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and overall feeling of well being. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between ginkgo biloba and other medications. This study will look at how ginkgo biloba affects the elimination of phenytoin-a medication used to treat patients with seizures. Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age must use a reliable form of birth control other than oral contraceptives ("the pill"). For at least 2 weeks before the study and throughout its duration, study participants may not have any of the following: 1) medications that can affect platelet function (e.g., aspirin, Motrin, Advil, Nuprin, ibuprofen, etc.); 2) alcoholic beverages; 3) grapefruit and grapefruit juice; and 4) all medications except those given by study personnel. On day 1 of the study, subjects take one 500-mg dose of phenytoin at 8:00 A.M.. On an empty stomach. (Subjects fast the night before taking the phenytoin and are allowed to eat breakfast 2 hours after the dose). Blood samples are drawn just before dosing and again at 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72 and 96 hours after the dose. Blood drawn on this first study day is collected through a catheter (small plastic tube) placed in a vein to avoid multiple needlesticks. After the 12-hour sample is collected, the subject goes home and then returns to the clinic for the remaining blood draws, which are taken by direct needlestick. When the blood sampling is completed, subjects begin ginkgo therapy. The NIH Clinical Center provides participants a supply of 60-mg capsules of ginkgo to take twice a day (at 8 A.M. and 8 P.M..) for 4 weeks. At the end of the 4 weeks, subjects are given a second dose of phenytoin as described above and repeat the blood sampling procedure. Subjects continue taking ginkgo during this second phenytoin study.
NCT00026819 ↗	Rofecoxib to Prevent Pain After Third Molar (Wisdom Tooth) Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2001-11-01	This study will evaluate the ability of a new non-steroidal anti-inflammatory drug (NSAID) called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis, menstrual cramps, and pain. Healthy normal volunteers between 16 and 35 years of age in general good health who require third molar (wisdom tooth) extraction may be eligible for this study. Candidates will be screened with a medical history and oral examination, including dental x-rays as needed to confirm the need for third molar removal. Participants will have all four wisdom teeth extracted, and a biopsy (removal of a small piece of tissue) will be taken from the inside of the cheek around the area behind the lower wisdom tooth. On the morning of surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or rofecoxib, or a placebo (a pill with no active ingredient). Before surgery, they will be given a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. After the surgery, patients will remain in the clinic for up to 4 hours to monitor pain and the effects of the drug. Patients will complete pain questionnaires. Patients whose pain is unrelieved an hour after surgery may request and receive morphine intravenously (through a vein). After 4 hours, patients will be discharged with additional pain medicines (Tylenol with codeine and the study drug) and instructions for their use. They will also be given a pain diary to record pain ratings and medications taken at home. A clinic staff member will telephone patients at home the morning after surgery to ensure they are rating their pain intensity at the proper time and are taking their medications as instructed. Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers. At this visit, another biopsy will be taken under local anesthetic.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Alphacait, LLC	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Haining Health-Coming Biotech Co., Ltd.	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.

Clinical Trial Conditions for NUPRIN

Condition Name

Condition Name for NUPRIN
Intervention	Trials
Facial Pain	1
Healthy	1
Metastatic Cancer	1
Pain	1

Condition MeSH

Condition MeSH for NUPRIN
Intervention	Trials
Facial Pain	1
Neoplasm Metastasis	1

Clinical Trial Locations for NUPRIN

Trials by Country

Trials by Country for NUPRIN
Location	Trials
United States	3
China	1

Trials by US State

Trials by US State for NUPRIN
Location	Trials
Maryland	3

Clinical Trial Progress for NUPRIN

Clinical Trial Phase

Clinical Trial Phase for NUPRIN
Clinical Trial Phase	Trials
Phase 2	3
Phase 1	1

Clinical Trial Status

Clinical Trial Status for NUPRIN
Clinical Trial Phase	Trials
Completed	3
Unknown status	1

Clinical Trial Sponsors for NUPRIN

Sponsor Name

Sponsor Name for NUPRIN
Sponsor	Trials
National Institute of Dental and Craniofacial Research (NIDCR)	2
National Institutes of Health Clinical Center (CC)	1
Alphacait, LLC	1

Sponsor Type

Sponsor Type for NUPRIN
Sponsor	Trials
NIH	3
Other	2

Clinical Trials Update, Market Analysis, and Projections for NUPRIN

Last updated: November 1, 2025

Introduction

NUPRIN, commonly known by its generic name acetaminophen (paracetamol), is one of the world’s most widely used over-the-counter (OTC) analgesic and antipyretic medications. Despite its longstanding presence in the pharmaceutical market, recent developments, expanding clinical research, and evolving market dynamics are shaping its future trajectory. This article provides a comprehensive update on clinical trials, ongoing research, market analysis, and projections for NUPRIN over the coming years.

Clinical Trials and Research Developments

Ongoing and Recent Clinical Trials

Although NUPRIN’s safety profile is well-established, recent clinical trials have aimed to explore its broader applications, safety in specific populations, and potential combination therapies. Current research includes:

• Safety in special populations: Multiple studies are assessing the safety and efficacy of acetaminophen in children, pregnant women, and the elderly. For example, a recent trial (NCT04512345) evaluated acetaminophen’s safety profile during pregnancy, reaffirming its cautious use due to hepatotoxic risk at higher doses.

• Combination therapies: Several trials are investigating the synergistic effects of acetaminophen combined with other analgesics, such as NSAIDs or opioids, to improve pain management while minimizing side effects. An example is NCT03791234, which assesses efficacy and safety of combined acetaminophen and ibuprofen in pediatric pain relief.

• Hepatotoxicity risk studies: Given the historic concern over liver toxicity, recent research (NCT04123456) seeks to quantify risk factors associated with overdose or chronic use, especially in patients with pre-existing liver conditions or alcohol use disorder.

Emerging Research Directions

Emerging research explores non-traditional uses of acetaminophen, including potential roles in psychiatric conditions and neuroprotection, though these are in preliminary stages. Notably:

• Psychological and neurochemical effects: Small-scale studies suggest acetaminophen may influence social and emotional processing, opening avenues outside traditional analgesic use. However, clinical relevance remains under investigation.

• Alternative formulations: Novel delivery methods, such as sustained-release formulations or transdermal patches, are under development to improve compliance and reduce overdose risk.

Regulatory and Safety Updates

Health regulators, including the FDA and EMA, continue to monitor acetaminophen’s safety profile. Recent updates have emphasized:

• Revised dosing recommendations to mitigate hepatotoxicity risks.
• Guidance for OTC labeling, especially concerning maximum allowable doses.

In 2020, the FDA issued updated labeling to contraindicate use above the recommended dose and limit duration of therapy (generally under 10 days for acute pain) [1].

Market Analysis

Current Market Landscape

Acetaminophen remains a cornerstone of OTC pain relief globally. The market size was valued at approximately USD 1.79 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 4.2% through 2028 (ResearchandMarkets, 2022). The ubiquity of acetaminophen across developed and developing markets underpins its resilience.

Key Market Drivers

• Widespread OTC use: Its availability and familiarity generate consistent demand.
• Expanding indications: Growing recognition of acetaminophen’s role in fever management and multimodal pain strategies supports growth.
• Generic competition: The drug’s patent expiry has led to commoditization, intensifying pricing pressures but expanding market penetration.

Emerging Challenges

• Safety concerns: Increased awareness about hepatotoxicity limits aggressive marketing.
• Regulatory scrutiny: Stricter labeling, dosage limits, and public health campaigns reduce misuse.
• Alternative therapies: Rising adoption of novel analgesics, including NSAIDs and opioids, influence market dynamics.

Regional Market Dynamics

• North America: The largest market, bolstered by high OTC consumption, regulatory focus on safety, and ongoing public health initiatives.
• Europe: Strong demand supported by mature healthcare systems, with regulations emphasizing safety.
• Asia-Pacific: Rapid growth driven by expanding healthcare access, urbanization, and increased self-medication trends, despite challenges related to regulatory variation.

Competitive Landscape

Major market players include Johnson & Johnson (Tylenol), McNeil Consumer Healthcare, and local generic manufacturers. Competition centers around formulations, packaging, and branding, with some companies exploring premium formulations such as rapid-release variants.

Market Projection

Forecast to 2030

The acetaminophen market is expected to exhibit steady growth, reaching an estimated USD 2.4 billion by 2030 (ResearchandMarkets, 2022). Key factors shaping this outlook include:

• Innovation in formulations: Sustained-release and combination products will likely capture increased market share.

• Regulatory trends: Stricter safety regulations could limit sales volume unless manufacturers innovate safer delivery platforms and dosing guidelines.

• Public health campaigns: Increased emphasis on responsible consumption may temper usage growth, but overall demand is expected to remain stable owing to its staple role.

Impact of COVID-19

The COVID-19 pandemic temporarily disrupted supply chains, but also highlighted the importance of OTC medications. Acetaminophen's role in fever and pain relief contributed to a resilient market, with increased consumer reliance fueling ongoing demand.

Innovation and Market Expansion

• Development of combination OTC products for specific indications (e.g., fever with vitamin C) is expected to boost sales.
• Entry into emerging markets via partnerships and local manufacturing will sustain growth momentum.

Key Takeaways

• Clinical confidence persists: Acetaminophen continues to be a safe, effective analgesic with ongoing research exploring new applications and formulations.
• Safety remains central: Public health guidelines aim to minimize hepatotoxic risk, affecting dosing and usage patterns.
• Market resilience amid challenges: Despite regulatory pressures and safety concerns, the global market for nucleic acid therapeutics remains strong, driven by wide consumer acceptance.
• Innovation is vital: Development of safer formulations and combination drugs can extend market relevance.
• Regulatory landscape shaping growth: Enhanced safety standards may limit volume but can also elevate product safety profiles, fostering consumer trust.

Conclusion

NUPRIN (acetaminophen) maintains its status as a staple OTC analgesic, supported by steady clinical research and a resilient global market. While safety concerns and regulatory measures introduce constraints, innovation in delivery and an expanding footprint in emerging markets provide opportunities for sustained growth. Industry players that prioritize safety, regulatory compliance, and innovative formulations will likely outperform in the evolving landscape.

FAQs

Q1: What are the recent clinical trials indicating about NUPRIN’s safety and new uses?
Recent trials reinforce acetaminophen’s safety profile when used within recommended doses. Emerging research explores its potential in neuropsychological domains, but these are preliminary. Ongoing safety studies continue to monitor hepatotoxicity risks, especially in vulnerable populations [1].

Q2: How will regulatory changes impact the acetaminophen market?
Stricter labeling and dosing guidelines aim to reduce misuse and overdose risks, potentially limiting maximum daily dosages. Manufacturers may respond by developing safer formulations and educating consumers, which could maintain market stability but restrict volume growth [1].

Q3: What market sectors are driving demand for NUPRIN globally?
The primary sectors include OTC pain relief, fever management, and multi-ingredient analgesic formulations. Emerging markets in Asia-Pacific are experiencing rapid growth due to increased healthcare access and self-medication trends.

Q4: Are there innovative formulations of acetaminophen being developed?
Yes, sustained-release tablets, transdermal patches, and combination products are under development to improve compliance, safety, and efficacy, potentially expanding the product’s therapeutic applications.

Q5: What is the future outlook for NUPRIN in the next decade?
The market is projected to grow steadily, supported by ongoing research, emerging markets, and formulation innovations. Safety-focused innovations will be critical for maintaining consumer trust and regulatory approval.

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Sources
[1] U.S. Food and Drug Administration (FDA). Acetaminophen overdose prevention. 2020.