Tylenol

(acetaminophen)

ApprovedSmall molecule

Acetaminophen is used to reduce fever and relieve mild to moderate pain, such as headaches, muscle aches, and cold symptoms.[2] Tylenol is currently approved and in use across 167 indications[4].[1]

Tylenol is one of 2441 small molecule programs targeting HIV infection. It is currently in Approved.

167

Indications

452

Total Trials

Active Trials

2,440

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionApproved

Systemic Lupus ErythematosusActive, not recruiting

Cleft PalateApproved

Respiratory Tract InfectionActive, not recruiting

Neuropathic PainApproved

Esophageal Squamous Cell CarcinomaRecruiting

Low Back PainActive, not recruiting

Rib FractureActive, not recruiting

Neck PainActive, not recruiting

Extramammary Paget DiseaseApproved

HIV InfectionApproved

Approved

Systemic Lupus ErythematosusPhase 3

Active, not recruiting

Cleft PalateApproved

Approved

Respiratory Tract InfectionApproved

Active, not recruiting

Neuropathic PainApproved

Approved

Esophageal Squamous Cell CarcinomaPreclinical

Recruiting

Low Back PainPhase 3

Active, not recruiting

Rib FractureApproved

Active, not recruiting

Neck PainPhase 2

Active, not recruiting

Extramammary Paget DiseaseApproved

Approved

Showing 10 of 158 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Tylenol

KKenvue Brands

Approved

1 2

Halaven

Eisai

Preclinical

38 3

Prolia

Amgen

Preclinical

14 4

DATROWAY

Daiichi Sankyo

Preclinical

4 5

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 6

Nubain

AAultman Health Foundation

Preclinical

1 7

Vfend

PPrism Pharmaceuticals

Preclinical

—8

Fentanyl Citrate

IINSYS Therapeutics Inc

Preclinical

2 9

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 10

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Pain Perception

NCT05919745

Q1 2027

Phase 2Active, not recruiting

Multiple Myeloma

NCT04268498

Q2 2027

N/ANot yet recruiting

Ischemic Stroke

NCT06767969

Phase 2Recruiting

Premature Infants

NCT05340582

Post-ApprovalNot yet recruiting

Intrapartum Fever

NCT06950840

Q3 2027

Phase 2Recruiting

Multiple Myeloma

NCT06356571

Clinical

Trials by Indication[1]

Acetaminophen27 trials

Efficacy of IV Acetaminophen Versus Oral Acetaminophen

Completed·UUniversity of Rochester·Phase 4·NCT03365622·214 enrolled

The Effects of Acetaminophen on Fear

Completed·—·N/A·NCT05396677·266 enrolled

A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy

Completed·NNevakar, Inc.·Phase 2·NCT04495283·87 enrolled

Show 24 more trials

Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen

Completed·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 2/3·NCT04459117·804 enrolled

Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement

Completed·UUniversity of Missouri, Kansas City·Phase 4·NCT00484744·35 enrolled

Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

Completed· AbbVie logo

AbbVie·Phase 2·NCT01038609·250 enrolled

Intravenous Acetaminophen for Craniotomy Patients

Unknown status·SSwedish Medical Center·Phase 2·NCT01474304·80 enrolled

Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers

Completed·—·Phase 4·NCT00400621·150 enrolled

Acetaminophen and Post Circumcision Pain Control

Terminated·—·Phase 4·NCT02498483·11 enrolled

Acetaminophen IV vs Hydromorphone IV in the ED

Completed·MMontefiore Medical Center·Phase 4·NCT03107481·220 enrolled

An Effectiveness and Safety Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain.

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 4·NCT00240825·222 enrolled

Evaluation of the Interaction Between Acetaminophen and Zidovudine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000731·10 enrolled

A Relative Bioavailability Study of Acetaminophen 650 mg Extended Release Gelcaps Under Fed Condition

Completed·RRanbaxy Laboratories Limited·N/A·NCT01079078·26 enrolled

Pain and Acetaminophen in Women Study

Completed·OOhio State University··NCT04573426·200 enrolled

A Study of Newly Formulated Tylenol Tablet (Acetaminophen) and Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04214691·30 enrolled

A Study of the Newly Formulated Tylenol Tablet (Acetaminophen) to the Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04230252·30 enrolled

Effects of Acetaminophen on Hurt Feelings

Completed·UUniversity of Toronto·N/A·NCT00561288·60 enrolled

Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days

Completed·KKennon Heard·Phase 4·NCT00616018·35 enrolled

Acetaminophen (APAP) +/- Oxycodone

Completed·MMontefiore Medical Center·Phase 4·NCT04122443·393 enrolled

Intravenous Acetaminophen in Craniotomy

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT01598701·100 enrolled

Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And Atorvastatin

Completed· GSK logo

GSK·Phase 1·NCT00411190·32 enrolled

Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia

Completed·WWeill Medical College of Cornell University·Phase 4·NCT05544734·20 enrolled

Comparison of Acetaminophen and PRP Therapy for Knee OA

Completed·HHospital Universitario Dr. Jose E. Gonzalez·N/A·NCT01782885·543 enrolled

A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults

Withdrawn·UUniversity of Texas Southwestern Medical Center·N/A·NCT00855049

Adjuvant Analgesic Effects of Low Dose Tramadol/Acetaminophen Combination After Open Gynaecological Surgery

Completed·TThe University of Hong Kong·Phase 4·NCT00942565·60 enrolled

Ibuprofen IV vs Acetaminophen IV for the Treatment of Pain Following Orthopaedic Low Extremity Surgery

Completed·IIndonesia University·N/A·NCT03771755·62 enrolled

Clinical, Pharmacological and Molecular Effects of IV and Oral Acetaminophen in Adults With aSAH

Terminated·MMilton S. Hershey Medical Center·Phase 4·NCT02549716·3 enrolled

Multiple Myeloma7 trials

An Efficacy and Safety Study of Daratumumab in Patients With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor [PI] and Immunomodulatory Drug [IMiD]) or Are Double Refractory to a PI and an IMiD

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01985126·124 enrolled

Melphalan on Disease Burden Measured by Next Generation Sequencing Before AHCT (Autologous Hematopoietic Cell Transplant) for Multiple Myeloma

Withdrawn·KKoen van Besien·Phase 1·NCT05013437

A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

Recruiting· Sanofi logo

Sanofi·Phase 2·NCT06356571·64 enrolled

Show 4 more trials

Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT04270409·337 enrolled

A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

Active, not recruiting· Sanofi logo

Sanofi·Phase 2·NCT05704049·118 enrolled

A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01998971·240 enrolled

A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma

Active, not recruiting·UUniversity of Miami·Phase 2·NCT04268498·310 enrolled

Osteoarthritis5 trials

Glucosamine Unum In Die [Once A Day] Efficacy (GUIDE) Trial: Glucosamine Sulfate in Patients With Knee Osteoarthritis

Completed·RRottapharm·Phase 3·NCT00110474·300 enrolled

Maxi-Analgesic Osteoarthritis (OA) Study

Withdrawn·AAFT Pharmaceuticals, Ltd.·Phase 3·NCT01420666

A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 3·NCT00568295·403 enrolled

Show 2 more trials

Toward Better Outcomes in Osteoarthritis

Completed·SStanford University·Phase 3·NCT00000425·900 enrolled

A Safety and Effectiveness Study of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 3·NCT00240773·581 enrolled

Postoperative Pain Control4 trials

Oral Versus Intravenous Acetaminophen for Postoperative Pain Control

Terminated·NNorthwell Health·N/A·NCT04662567·42 enrolled

Postoperative Pain Control & Relief in Neonates

Terminated·SSt. Louis University·Phase 4·NCT03677830·11 enrolled

Post Operative Pain Control After Pediatric Hip Surgery

Terminated·SSeattle Children's Hospital·N/A·NCT03435692·42 enrolled

Show 1 more trial

Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control

Completed·SSeoul National University Hospital·N/A·NCT03644147·84 enrolled

Pain Management4 trials

Pain Management in Head and Neck Surgery Patients

Withdrawn·UUniversity of Alabama at Birmingham·Phase 4·NCT03121963

Transversus Abdominis Plane Block Versus Ilioinguinal Nerve Block for Pain Management in Inguinal Herniorraphy

Completed·—·N/A·NCT02375100·90 enrolled

Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT03859024·48 enrolled

Show 1 more trial

Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery

Withdrawn·UUniversity of Miami·Phase 3·NCT05965492

128 more indications

Pediatric Patients3 trials

A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients

Completed·AArlyne Thung·Phase 2·NCT03714919·10 enrolled

Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Completed·CCumberland Pharmaceuticals·Phase 3·NCT01002573·118 enrolled

Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Patients With Acute Sickle Cell Crises?

Completed·NNewark Beth Israel Medical Center·Phase 4·NCT03541980·71 enrolled

Multimodal Analgesia3 trials

Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries

Recruiting·NNorthwell Health·Phase 4·NCT06379425·70 enrolled

PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery

Completed·WWashington University School of Medicine·Phase 2·NCT03084536·134 enrolled

A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery

Completed·UUniversity of Utah·Phase 4·NCT04015908·100 enrolled

Tonsillectomy3 trials

Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy

Withdrawn·MMassachusetts Eye and Ear Infirmary·Phase 1·NCT03385057

Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy

Terminated·—·Phase 1/2·NCT04791761·73 enrolled

Celecoxib After Tonsillectomy

Completed·—·Phase 2·NCT02934191·172 enrolled

Post Operative Pain2 trials

The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy

Completed·SStanford University·Phase 4·NCT03445390·27 enrolled

Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction

Unknown status·—·Phase 4·NCT03105518·100 enrolled

Opioid Analgesia2 trials

Nonopioid Analgesia After Rotator Cuff Repair

Completed·HHenry Ford Health System·Phase 2·NCT03818919·70 enrolled

Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.

Completed·MMontefiore Medical Center·Phase 3·NCT03584373·119 enrolled

Hysterectomy2 trials

TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy

Completed·UUniversity of Minnesota·Phase 4·NCT02519023·87 enrolled

Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy

Withdrawn·MMontefiore Medical Center·Phase 2/3·NCT04360135

Intensive Care Unit2 trials

Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit

Unknown status·MMcMaster Children's Hospital·Phase 4·NCT05678244·60 enrolled

Safety and Efficacy of Acetaminophen in the Intensive Care Unit.

Terminated·UUniversity of British Columbia·Phase 4·NCT02280239·10 enrolled

Transplantation2 trials

Allogeneic Transplantation From Related Haploidentical Donors

Completed·SStanford University·Phase 2·NCT00185692·16 enrolled

Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG

Completed·SStanford University·Phase 2·NCT00899847·9 enrolled

Acute Dental Pain2 trials

Maxigesic 325 Acute Dental Pain Study

Completed·AAFT Pharmaceuticals, Ltd.·Phase 3·NCT01420653·408 enrolled

Preemptive Analgesia With Celecoxib for Acute Dental Pain Management

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT04790812·65 enrolled

Lupus Nephritis2 trials

Rituximab and Belimumab for Lupus Nephritis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT02260934·43 enrolled

A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis

Completed· Roche logo

Roche·Phase 3·NCT00282347·144 enrolled

Surgery2 trials

A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE

Completed·HHeron Therapeutics·Phase 4·NCT06109428·30 enrolled

A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.

Unknown status·HHeron Therapeutics·Phase 4·NCT05109312·90 enrolled

Premedication2 trials

Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection

Completed·—·Phase 2·NCT02601911·60 enrolled

Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain

Completed·—·Phase 2·NCT02614118·66 enrolled

Cesarean Section2 trials

Comparison of Different Methods of Pain Control After Cesarean Section for Patients on Buprenorphine or Methadone

Withdrawn·—·N/A·NCT02091297

A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section

Unknown status·MMain Line Health·Phase 4·NCT04290208·130 enrolled

Delirium2 trials

Impact of Acetaminophen on Postoperative Delirium Elderly Patients After Non-cardiac Surgery

Unknown status·XXiangya Hospital of Central South University·Phase 1·NCT03763084·164 enrolled

Delirium in Elderly Patients With Trauma of the Hip

Terminated·—·Phase 4·NCT02689024·239 enrolled

Prospective2 trials

A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme

Completed· Sanofi logo

Sanofi·Phase 4·NCT06019728·8 enrolled

Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children

Unknown status·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 4·NCT02294071·120 enrolled

Renal Colic2 trials

Comparing the Analgesic Effect of Intravenous Acetaminophen and Morphine on Patients With Renal Colic Pain Reffering to the Emergency Department: A Randomized Controlled Trial

Completed·SSeyed Mehdi Pourafzali·Phase 2·NCT01906762·124 enrolled

Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics

Recruiting·UUniversity of Monastir·Phase 2·NCT05722782·500 enrolled

Analgesia2 trials

SPI-directed Analgesia for Vitreoretinal Surgeries

Completed·MMedical University of Silesia·N/A·NCT02973581·176 enrolled

Pre-induction Analgesia: Multimodel Regimen vs Aceteminophen for Post Ureteroscopy Pain

Withdrawn·KKevin J Flynn MD·Phase 4·NCT03549611

Analgesic2 trials

Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction

Completed·UUniversity of Pennsylvania·Phase 1·NCT03893175·86 enrolled

Evaluation of Ketamine and Multi-modal Analgesics

Withdrawn·UUniversity of Florida··NCT02815111

Treatment2 trials

Canadian National PDA Treatment Study

Completed·IIWK Health Centre··NCT04347720·1,663 enrolled

Pre-emptive Analgesics in Orthodontic Treatment

Completed·UUniversity of Washington·Phase 4·NCT03523988·73 enrolled

Intrapartum Fever2 trials

Antipyretic Treatment for Intrapartum Fever: Dipyrone vs Acetaminophen (RCT)

Not yet recruiting·WWolfson Medical Center·Phase 4·NCT06950840·140 enrolled

Reduction of Intrapartum Fever With Intravenous Acetaminophen

Unknown status·—·Phase 2·NCT02625454·168 enrolled

Intravenous2 trials

Analgesic Effects of Intravenous Paracetamol on Labor Pain

Completed·KKing Abdulaziz University·Phase 4·NCT01394731

Opioid-sparing Effect of Intravenous Ibuprofen

Unknown status·MMuharrem Ucar·Phase 4·NCT03016650·80 enrolled

Brain Injury2 trials

Ibuprofen Versus Acetaminophen for Treatment of Mild Traumatic Brain Injury

Withdrawn·NNorthwestern University·Phase 2·NCT02443142

A Cohort Study Evaluating the Efficacy of PO Magnesium in the Treatment of Acute Traumatic Brain Injury in Adolescents

Completed·CCorewell Health South·Phase 1·NCT03475693·17 enrolled

Opioid Use1 trial

Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion

Terminated·TTexas Tech University Health Sciences Center·Phase 4·NCT02061774·21 enrolled

Joint Replacement Surgery1 trial

Effect of Combined Use of Naloxone and Tramacet on Postop Analgesia in Elderly Patients Having Joint Replacement Surgery

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 3·NCT00679614·45 enrolled

Pain Control1 trial

Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures

Recruiting·MMayo Clinic·Phase 4·NCT05076110·188 enrolled

Multimodal Pain Management1 trial

Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial

Not yet recruiting·UUniversity of Puerto Rico·N/A·NCT06917118·100 enrolled

Total Knee Arthroplasty1 trial

Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen

Completed·HHeron Therapeutics·Phase 3·NCT03974932·116 enrolled

Pain1 trial

A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00737048·328 enrolled

Advanced Solid Cancers1 trial

An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers

Completed·HHenlix, Inc·Phase 1·NCT02648490·19 enrolled

ACL Reconstruction1 trial

Impact of Opioid Avoidance Protocol for ACL Reconstruction

Completed·MMatthew Varacallo··NCT06340932·32 enrolled

Patent ductus arteriosus1 trial

IV Acetaminophen and Patent Ductus Arteriosus

Completed·—·N/A·NCT03008876·10 enrolled

Postoperative Pain Management1 trial

Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

Completed·NNanjing Children's Hospital·Phase 1·NCT05564819·220 enrolled

Shoulder Arthroplasty1 trial

Opioid-Free Shoulder Arthroplasty

Completed·OOrthoCarolina Research Institute, Inc.·Phase 4·NCT03540030·86 enrolled

Inguinal hernia1 trial

Fascia Transversalis Versus Transversus Abdominis Plane Block for Children Undergoing Inguinal Hernia Surgery

Recruiting·KKasr El Aini Hospital·Phase 2·NCT06326944·50 enrolled

Intravenous Administration1 trial

Comparative Study Between the Prophylactic Intravenous Administrations of Acetaminophen vs Dexamethasone vs Pethidine Regarding the Incidence of Shivering Induced by Single Shot Spinal Anesthesia in the Orthopedic Surgeries of the Lower Limbs

Completed·—·Phase 4·NCT05284409·130 enrolled

Sickle Cell Disease1 trial

Abatacept for GVHD Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease

Completed·MMonica Bhatia·Phase 1·NCT02867800·24 enrolled

Erector Spinae Plane Block1 trial

Erector Spinae Plane Block in Scoliotic Adolescents

Completed·KKasr El Aini Hospital·Phase 2·NCT03968146·30 enrolled

Perioperative Pain Control1 trial

Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery

Unknown status·UUniversity of Illinois College of Medicine at Peoria·Phase 4·NCT02958566·80 enrolled

Arthritis1 trial

Symptomatic Management of Lyme Arthritis

Terminated·—·Phase 3·NCT04038346·3 enrolled

Ischemic stroke1 trial

Effect of Acetaminophen on Neurological Outcome in Acute Ischemic Stroke Patients Undergoing Endovascular Treatment

Not yet recruiting·—·N/A·NCT06767969·892 enrolled

Colorectal Surgery1 trial

Ketamine in Colorectal Surgery

Withdrawn·MMedical College of Wisconsin·Phase 4·NCT02785003

ART1 trial

A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT03649165·24 enrolled

Caesarean Section1 trial

HTX-011 Administration Study in Planned Caesarean Section Procedure

Completed·HHeron Therapeutics·Phase 2·NCT03955211·25 enrolled

Homocystinuria1 trial

Effect of Acetaminophen and N-Acetylcysteine on Liver Metabolism on Homocystinuria

Suspended·HHospital de Clinicas de Porto Alegre·Phase 1/2·NCT04015557·10 enrolled

Follicular Lymphoma1 trial

A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06043323·20 enrolled

Thoracic Surgery1 trial

Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery

Completed·WWake Forest University Health Sciences·N/A·NCT02112448·78 enrolled

Systemic Lupus Erythematosus1 trial

A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

Terminated· Roche logo

Roche·Phase 3·NCT00381810·31 enrolled

Sepsis1 trial

Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients

Completed·—·Phase 4·NCT06061575·113 enrolled

Migraine1 trial

Cefalium® Compared to Tylenol® in the Treatment of Migraine Attacks

Suspended·AAche Laboratorios Farmaceuticos S.A.·Phase 3·NCT02582996·336 enrolled

Pulpitis1 trial

Preoperative Acetaminophen- Caffeine- Codeine Combination and Anaesthetic Success in Patients With Acute Pulpitis

Completed·—·N/A·NCT04202406·69 enrolled

Pompe Disease1 trial

Re-administration of Intramuscular AAV9 in Patients With Late-Onset Pompe Disease

Completed·UUniversity of Florida·Phase 1·NCT02240407·2 enrolled

Ankle Injuries1 trial

Correlation Between Acute Analgesia and Long-Term Function Following Ankle Injuries

Completed·CCanadian Department of National Defence·Phase 4·NCT02667730·168 enrolled

Pneumonia1 trial

NSAIDs Treatment in Children With Pleuropneumonia

Unknown status·RRabin Medical Center·N/A·NCT01586299·40 enrolled

Effectiveness1 trial

Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial

Recruiting·UUniversity of Michigan·Phase 4·NCT06671002·900 enrolled

Alpha-1 Antitrypsin Deficiency1 trial

Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (Liver AATD)

Completed·UUniversity of Florida··NCT01810458·109 enrolled

Rib Fracture1 trial

Vital Capacity in Ultrasound Guided Serratus Plane Block in ED Patients With Multiple Rib Fractures

Terminated·AAntonios Likourezos·Phase 4·NCT04530149·3 enrolled

Mechanical Ventilation1 trial

Optimizing Pain Treatment in Children On Mechanical Ventilation

Recruiting·WWeill Medical College of Cornell University·Phase 3·NCT06994442·644 enrolled

Sleep1 trial

Sleep Disruption in New Mothers: An Intervention Trial

Completed·UUniversity of California, San Francisco·N/A·NCT01321710·152 enrolled

Cardiac Surgery1 trial

Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery

Unknown status·WWestern University, Canada·N/A·NCT03128346·100 enrolled

Randomized Controlled Trial1 trial

Acetaminophen Randomized Controlled Trial

Withdrawn·NNYU Langone Health·Phase 3·NCT02737124

Prostatectomy1 trial

Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy

Withdrawn·WWake Forest University Health Sciences·Phase 2/3·NCT04939987

Post Operative Cognitive Dysfunction1 trial

Active Temperature Management After Cardiac Surgery and Its Effect on Postoperative Cognitive Dysfunction

Withdrawn·VVirginia Commonwealth University·Phase 2·NCT03947671

Weight loss1 trial

Effect of Number of Meals on Metabolism After Weight Loss Surgery

Completed·—·N/A·NCT02929212·33 enrolled

HIV-1 infection1 trial

Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000875·16 enrolled

GLP-11 trial

The Impact of Gall Bladder Emptying and Bile Acids on the Human GLP-1-secretion

Completed·FFilip Krag Knop·N/A·NCT01656057·10 enrolled

Musculoskeletal Pain1 trial

Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting

Completed·SStony Brook University·Phase 2·NCT01827475·90 enrolled

Malignant Mesothelioma1 trial

Intratumor Injection of Anti-Mesothelin Immunotoxin LMB-100 With Ipilimumab in Malignant Mesothelioma

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT04840615·2 enrolled

Respiratory tract infection1 trial

Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections

Terminated· Novartis logo

Novartis·Phase 4·NCT01019980·2 enrolled

Hernia1 trial

Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Hernia Repair

Unknown status·—·N/A·NCT03041948·88 enrolled

Hairy Cell Leukemia1 trial

Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT01059786·69 enrolled

Vaccine1 trial

Wilm's Tumor 1 Protein Vaccine to Treat Cancers of the Blood

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00923910·10 enrolled

Tibia Fracture1 trial

NSAID Use and Healing After Tibia Fractures and Achilles Tendon Ruptures

Unknown status·UUniversity of California, Los Angeles·N/A·NCT03880981·456 enrolled

Indomethacin1 trial

Indomethacin and Cardiac Bypass Surgery

Completed·QQueen's University·Phase 4·NCT01073670·82 enrolled

Back pain1 trial

Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department

Completed·SSan Antonio Military Medical Center·N/A·NCT03996564·26 enrolled

Immunoglobulin G4-related Disease1 trial

Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04918147·8 enrolled

Pediatric Solid Tumor1 trial

Acetaminophen Before Surgery Lowers Postop Pain in Pediatric Solid Tumor Patients (ERAS)

Completed·NNanjing Children's Hospital·Phase 1·NCT07095816·182 enrolled

Donor1 trial

Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT02474199·15 enrolled

Aneurysm1 trial

Efficacy of the Ultrasound-guided Transversus Abdominis Plane Block in Open Aortic Abdominal Aneurysm Repair Surgery

Unknown status·—·Phase 3·NCT02292667·60 enrolled

Kidney Transplant1 trial

Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT02495077·290 enrolled

Hypertensive1 trial

NSAID Use in Postpartum Hypertensive Women

Terminated·SSt. Louis University·Phase 4·NCT02902172·36 enrolled

Dementia1 trial

Delta-THC in Dementia

Completed·RRadboud University Medical Center·Phase 2·NCT01608217·50 enrolled

Preeclampsia1 trial

Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

Completed·—·Phase 2/3·NCT01988298·114 enrolled

Asthma1 trial

Acetaminophen Versus Ibuprofen in Children With Asthma

Completed·MMilton S. Hershey Medical Center·Phase 3·NCT01606319·300 enrolled

Perioperative Analgesia1 trial

Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery

Terminated·—·Phase 3·NCT04176419·30 enrolled

General Anesthesia1 trial

Multi-dose Acetaminophen for Patients Undergoing General Anesthesia

Terminated·RRutgers, The State University of New Jersey·Phase 4·NCT02832687·88 enrolled

Clinical Trial1 trial

A Randomized Clinical Trial of the Effectiveness of Acupressure in Relieving Orthodontic Pain

Not yet recruiting·UUniversity of Baghdad·Phase 1·NCT06812936·56 enrolled

Bariatric Surgery1 trial

A Trial of the Cost Effectiveness of IV Acetaminophen in Bariatric Surgery

Completed·—·Phase 4·NCT02233400·113 enrolled

Hemodynamic Response1 trial

Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults

Completed·UUniversity of California, San Francisco·Phase 4·NCT01869699·41 enrolled

Diverticulitis1 trial

Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics

Completed·CCorporacion Parc Tauli·Phase 4·NCT02785549·480 enrolled

Papilloma1 trial

E7 TCR T Cells for Human Papillomavirus-Associated Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT02858310·224 enrolled

Absorption1 trial

Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

Completed·UUniversity of Reading·Phase 1·NCT01790009·40 enrolled

Hepatic Tumors1 trial

APAP-CYS Protein Adduct Concentrations in Patients With Liver-Directed Therapy Intended to Treat Hepatic Tumors

Withdrawn·—·Phase 4·NCT02911961

Spinal Fusion1 trial

Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes

Completed·HHospital for Special Surgery, New York·N/A·NCT02700451·178 enrolled

Quadratus Lumborum Block1 trial

Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Caesarean Section.

Completed·ZZealand University Hospital·Phase 4·NCT03068260·72 enrolled

Menopausal Women1 trial

Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass

Completed· Novartis logo

Novartis·Phase 4·NCT00489424·793 enrolled

Trial1 trial

Management Of Pain After Cesarean Trial

Terminated·MMilton S. Hershey Medical Center·Phase 3·NCT03929640·49 enrolled

Immunotherapy1 trial

Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT03493945·59 enrolled

Phase 21 trial

Phase 2 Poor Risk DLBCL of TLI and ATG Followed by Matched Allogeneic HT as Consolidation to Autologous HCT

Terminated·SStanford University·Phase 2·NCT00482053·3 enrolled

Bunion1 trial

Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

Completed·CConcentric Analgesics·Phase 2·NCT03599089·147 enrolled

Platelet Aggregation1 trial

Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation in Analgetic Dosages

Completed·RRuhr University of Bochum·N/A·NCT00763997·80 enrolled

Analgesic Efficacy1 trial

Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet)

Completed·AAntonios Likourezos·Phase 2·NCT03088826·80 enrolled

Psoriasis1 trial

Treatment of Mild to Moderate Joint Pain in Patients With Chronic Plaque Psoriasis Receiving Efalizumab

Completed·PProbity Medical Research·Phase 4·NCT00510536·50 enrolled

Bone Fracture1 trial

Oral vs IV Acetaminophen for Long-bone Fracture in Children

Unknown status·—·Phase 4·NCT05557344·20 enrolled

Dental Implant1 trial

OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients

Completed·HHersh, Elliot V., DMD, MS, PhD·Phase 4·NCT04694300·30 enrolled

Epidural Analgesia1 trial

Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery

Unknown status·OOspedale San Raffaele·N/A·NCT02647047·40 enrolled

Small Bowel Obstruction1 trial

A Study of Intravenous Acetaminophen for Small Bowel Obstruction

Enrolling by invitation·MMayo Clinic·Phase 4·NCT05878015·18 enrolled

Ketorolac1 trial

An Evaluation of Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision

Completed·—·Phase 2·NCT04646967·100 enrolled

Completed·—·N/A·NCT03041935·90 enrolled

Solid Tumors1 trial

Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03554005·29 enrolled

Pulmonary Arterial Hypertension1 trial

Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01086540·57 enrolled

Patient Satisfaction1 trial

Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery

Terminated·MMassachusetts General Hospital·Phase 4·NCT01588158·7 enrolled

Alzheimer's Disease1 trial

Behavioral Expressions in Alzheimer's Disease

Completed·UUniversity of Florida··NCT02719834·4 enrolled

Pain Perception1 trial

Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft

Recruiting·MMarquette University·Phase 4·NCT05919745·50 enrolled

Tooth Extraction1 trial

Pre-emptive Analgesic Administration in Primary Tooth Extraction

Completed·TTishreen University·Phase 2/3·NCT03786029·66 enrolled

Alveolar Soft Part Sarcoma1 trial

Sunitinib or Cediranib for Alveolar Soft Part Sarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01391962·34 enrolled

Post-cesarean Pain1 trial

Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management

Completed·SStanford University·N/A·NCT02605187·160 enrolled

Hemorrhage1 trial

Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants

Unknown status·KKing Saud Medical City·Phase 3·NCT03024814·300 enrolled

Radius Fracture1 trial

Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture

Terminated·UUniversity of Missouri-Columbia·Phase 4·NCT03749616·32 enrolled

Celiac Disease1 trial

Effect of Acetaminophen Versus Ibuprofen in Treating Recurrent Apthous Ulcers in Pediatric Celiac Disease

Unknown status·—·Phase 4·NCT06149507·12 enrolled

Premature Infants1 trial

Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants

Recruiting·MMount Sinai Hospital, Canada·Phase 2·NCT05340582·310 enrolled

Dysmenorrhea1 trial

NSAID Use for Treating Dysmenorrhea and Preventing Chronic Pelvic Pain (NSAID HEAL)

Recruiting·EEndeavor Health·Phase 4·NCT06861920·600 enrolled

Malaria1 trial

The Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau

Unknown status·BBandim Health Project·Phase 4·NCT00137566

Pharyngitis1 trial

A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis

Completed·RReckitt Benckiser LLC·Phase 3·NCT01048866·198 enrolled

Uncontrolled Gout1 trial

Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout

Completed· Amgen logo

Amgen·Phase 4·NCT03994731·152 enrolled

Chronic Neck Pain1 trial

Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain

Completed·UUniversity of Colorado, Denver·N/A·NCT00429624·70 enrolled

Gastric Emptying1 trial

Evaluation of Apraglutide on Gastric Emptying

Completed·VVectivBio AG·Phase 1·NCT05995704·42 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

ACEPHEN

NDA NDA018060

Jan 1, 1982

NEOPAP

NDA NDA016401

Jan 1, 1982

TYLENOL

NDA NDA017756

Sep 12, 1983

ACETAMINOPHEN

NDA NDA018337

Mar 7, 1986

INJECTAPAP

NDA NDA017785

Jun 8, 1994

TYLENOL

NDA NDA019872

Nov 2, 2010

OFIRMEV

NDA NDA022450

Oct 28, 2015

ACETAMINOPHEN

NDA NDA204767

Jan 15, 2021

ACETAMINOPHEN

NDA NDA206610

Feb 18, 2021

ACETAMINOPHEN

NDA NDA204957

Jun 3, 2022

ACETAMINOPHEN

NDA NDA206968

Sources

References

[1]
ClinicalTrials.gov — 452 trial records for acetaminophen. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tylenol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — acetaminophen compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for acetaminophen. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA206968). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tylenol. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Kenvue Brands company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclooxygenase Inhibitor; Anandamide Amidohydrolase Inhibitor; Vanilloid Receptor Opener[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: KKenvue Brands

Patent Landscape[6]

Patent Cliff

Nov 13, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9987238Nov 13, 2028

10383834Nov 13, 2028

9610265Nov 13, 2028

9987238*PEDMay 13, 2029

10383834*PEDMay 13, 2029

4 more patents

9610265*PEDMay 13, 2029

8741959Apr 19, 2030

9399012Sep 11, 2031

9399012*PEDMar 11, 2032