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 145 indications[4].[1]

Tylenol is one of 1715 small molecule programs targeting Obesity. It is currently in Approved.

145

Indications

469

Total Trials

Active Trials

1,714

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

ObesityActive, not recruiting

Total Knee ArthroplastyTerminated

Lupus NephritisCompleted

Post Operative PainCompleted

Nervous System DiseaseApproved

Chronic Myelogenous LeukemiaApproved

Kidney DiseaseApproved

Cleft PalateApproved

TicsTerminated

SepsisApproved

ObesityApproved

Active, not recruiting

Total Knee ArthroplastyApproved

Terminated

Lupus NephritisPhase 3

Completed

Post Operative PainApproved

Completed

Nervous System DiseaseApproved

Approved

Chronic Myelogenous LeukemiaApproved

Approved

Kidney DiseaseApproved

Approved

Cleft PalateApproved

Approved

TicsPhase 1

Terminated

SepsisApproved

Approved

Showing 10 of 139 indications

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

Tylenol

KKenvue Brands

Approved

1 2

Yervoy

Bristol-Myers Squibb

Preclinical

3 3

Nubeqa

Bayer

Preclinical

2 4

Zejula

GGlaxo Dba Glaxosmithkline

Preclinical

2 5

Augtyro

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

2 6

Paxil

SSebela Pharmaceuticals Development LLC

Preclinical

1 7

Proleukin

IIovance Biotherapeutics, Inc.

Preclinical

1 8

Epivir

GGlaxo Dba Glaxosmithkline

Preclinical

1 9

Carboplatin AUC-5

Merck & Co.

Preclinical

1 10

Soc

Pfizer

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Laparoscopic

NCT06434233

Post-ApprovalRecruiting

Pain Perception

NCT05919745

Phase 2Active, not recruiting

Phase II

NCT05285813

Post-ApprovalActive, not recruiting

Non-Opioid Pain Management

NCT06187584

Q1 2027

Post-ApprovalNot yet recruiting

Lumbar Spine Surgery

NCT07203079

Phase 2Active, not recruiting

Multiple Myeloma

NCT04268498

Clinical

Trials by Indication[1]

Acetaminophen36 trials

An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in Treating Muscle Aches and Soreness That Occur After a Marathon Race

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 4·NCT00240851·665 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

Acetaminophen (APAP) +/- Oxycodone

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

Show 33 more trials

Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement

Completed·RRio de Janeiro State University·Phase 4·NCT03568721·81 enrolled

Intravenous Acetaminophen in Craniotomy

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

A Relative Bioavailability Study of Acetaminophen Extended Release Gel Tabs 650 mg Under Fasting Condition

Completed·RRanbaxy Laboratories Limited·N/A·NCT01523080·32 enrolled

Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications

Completed·—··NCT03289390·11 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

A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

Completed·JJohnson & Johnson Consumer Inc. (J&JCI)·Phase 3·NCT05761574·447 enrolled

A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers

Completed·NNevakar, Inc.·Phase 1·NCT04265456·63 enrolled

Study of Acetaminophen (ACM) in Post-operative Dental Pain

Completed·JJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division·Phase 3·NCT02735122·420 enrolled

Study of Acetaminophen (ACE) in Post-operative Dental Pain

Completed·MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.·Phase 2·NCT02320708·240 enrolled

Analgesic Effect of IV Acetaminophen in Tonsillectomies

Completed·NNationwide Children's Hospital·Phase 2·NCT01691690·250 enrolled

PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement

Completed·KKettering Health Network·Phase 4·NCT02244619·515 enrolled

Prospective, Randomized, Double Blind Study Comparing IV vs PO Acetaminophen in Patients Undergoing Lumbar Discectomy

Unknown status·TThomas Jefferson University·N/A·NCT02067442·100 enrolled

Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain

Terminated·MMallinckrodt·Phase 4·NCT02746263·1 enrolled

A Study of Ibuprofen 250 mg / Acetaminophen 500 mg Comparing The Antipyretic Effects in Healthy Male Volunteers

Completed· Pfizer logo

Pfizer·Phase 3·NCT02761980·290 enrolled

Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV)

Completed·—·Phase 4·NCT02369211·86 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

Determine the Clinical Advantage of IV vs PO Acetaminophen

Completed·YYan Lai·Phase 4·NCT03558555·103 enrolled

Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery

Completed·UUniversity of Southern California·Phase 2·NCT03111186·40 enrolled

Equality Study of Ofirmev vs Oral Acetaminophen

Unknown status·—·Phase 4·NCT01711229·114 enrolled

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

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

Acetaminophen and Social Processes

Completed·OOhio State University·Phase 2·NCT02108990·9 enrolled

Acetaminophen vs Indomethacin in Treating hsPDA

Terminated·UUniversity of Tennessee·Phase 3·NCT03537144·37 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·NCT00240864·224 enrolled

Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen

Completed·UUniversity of California, Davis·Phase 4·NCT02994940·74 enrolled

Preoperative Acetaminophen and Carbohydrate Loading

Completed·TTufts Medical Center·Phase 3·NCT03131713·101 enrolled

Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever

Completed·PPenn State University·Phase 4·NCT00267293·60 enrolled

Institutional Audit of the Use of Intravenous Acetaminophen in Infants Undergoing Pyloromyotomy

Completed·AArlyne Thung··NCT02359305·68 enrolled

Usefulness of Acetaminophen Associated With Strong Opioids for Acute Pain in Cancer Patients

Completed·PPontificia Universidad Catolica de Chile·Phase 4·NCT04779567·112 enrolled

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

Completed·RRanbaxy Laboratories Limited·N/A·NCT01513668·40 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

Tonsillectomy4 trials

Celecoxib After Tonsillectomy

Completed·—·Phase 2·NCT02934191·172 enrolled

IV Acetaminophen and Post-Tonsillectomy Pain

Withdrawn·—·Phase 2·NCT03883893

Non-opioids for Analgesia After Adenotonsillectomy in Children

Terminated·—·Phase 1/2·NCT03618823·268 enrolled

Show 1 more trial

Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy

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

Postoperative Pain Control4 trials

Post Operative Pain Control After Pediatric Hip Surgery

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

Postoperative Pain Control in Septum and Sinus Surgery

Completed·CCorewell Health East·Phase 4·NCT04149964·65 enrolled

Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

Completed·MMedical University of South Carolina·N/A·NCT02487303·148 enrolled

Show 1 more trial

Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control

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

Multiple Myeloma4 trials

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

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

Show 1 more trial

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

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT04270409·337 enrolled

Spinal Fusion3 trials

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

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

Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery

Completed·—·Phase 3·NCT04959591·99 enrolled

Multi-Modal Anesthesia Protocol in Pain Management of Patients Undergoing Posterior Lumbar Spinal Fusion Surgery

Completed·UUniversity of Puerto Rico·Phase 4·NCT05413902·100 enrolled

122 more indications

Cesarean Section3 trials

Preoperative Cesarean Section Intravenous Acetaminophen and Postoperative Pain Control

Unknown status·UUniversity of Tennessee Graduate School of Medicine·Phase 1·NCT02694653·200 enrolled

High Pain Intervention in Cesarean Sections

Completed·WWake Forest University Health Sciences·N/A·NCT01298778·69 enrolled

Comparing Protocols for Analgesia Following Elective Cesarean Section

Unknown status·WWolfson Medical Center·Phase 4·NCT03622489·120 enrolled

Osteoarthritis3 trials

An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee.

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 3·NCT00240799·542 enrolled

An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 3·NCT00240786·483 enrolled

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

Pain Management3 trials

Pain Management in Head and Neck Surgery Patients

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

Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates

Completed·RRawalpindi Medical College·N/A·NCT06638086·64 enrolled

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

Withdrawn·UUniversity of Miami·Phase 3·NCT05965492

Transplantation2 trials

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

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

Allogeneic Transplantation From Related Haploidentical Donors

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

Patient Satisfaction2 trials

Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery

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

Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients

Withdrawn·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT02160301

Kidney Transplant2 trials

Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults

Completed·UUniversity of Wisconsin, Madison·Phase 1/2·NCT00078559·10 enrolled

Treg Therapy in Subclinical Inflammation in Kidney Transplantation

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT02711826·32 enrolled

Phase 22 trials

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

Phase 2 Herniorrhaphy Study for Opioid Elimination

Completed·HHeron Therapeutics·Phase 2·NCT03695367·63 enrolled

Total Hip Arthroplasty2 trials

IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty

Completed·HHospital for Special Surgery, New York·Phase 4·NCT03020966·154 enrolled

Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty

Completed·—·Phase 4·NCT02839876·81 enrolled

Prospective2 trials

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

Prospective, Double Blind, Placebo Control, Bariatric IV Ace

Completed·WWeill Medical College of Cornell University·Phase 4·NCT02452320·136 enrolled

Laparoscopic2 trials

TQL-block for Laparoscopic Hemicolectomy

Completed·ZZealand University Hospital·Phase 4·NCT03570541·69 enrolled

Opioid Use After Laparoscopic Salpingectomy

Recruiting·JJohns Hopkins University·Phase 4·NCT06434233·120 enrolled

Shoulder Arthroplasty2 trials

Multimodal Analgesia in Shoulder Arthroplasty

Withdrawn·RRush University Medical Center·Phase 3·NCT03586934

Opioid-Free Pain Protocol After Shoulder Arthroplasty

Active, not recruiting·HHenry Ford Health System·Phase 4·NCT05488847·83 enrolled

Sinus Surgery2 trials

Acetaminophen Given Per Os and Intravenous in Sinus Surgery

Unknown status·MMassachusetts Eye and Ear Infirmary·Phase 3·NCT03295214·124 enrolled

Pain Control Following Sinus Surgery

Completed·SStanford University·Phase 4·NCT03783702·118 enrolled

Multimodal Analgesia2 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

A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery

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

Postoperative Pain Management2 trials

Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

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

Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy

Completed·AAdventHealth·Phase 4·NCT02025634·119 enrolled

Leukemia2 trials

Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Terminated· Sanofi logo

Sanofi·Phase 2·NCT02999633·14 enrolled

Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT03913559·5 enrolled

Drug Metabolism2 trials

Effect of Testosterone Treatment on Drug Metabolism and Transport

Active, not recruiting·UUniversity of Washington··NCT05116293·12 enrolled

Effect of Estrogen Treatment on Drug Metabolism and Transport

Completed·UUniversity of Washington·Phase 4·NCT05469204·22 enrolled

Dysmenorrhea2 trials

A Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea

Completed· Bayer logo

Bayer·Phase 4·NCT03448536·201 enrolled

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

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

Hepatic Function2 trials

Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

Completed·—·Phase 4·NCT00427206·181 enrolled

Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics

Completed·—·Phase 4·NCT00402571·420 enrolled

Malaria2 trials

Aggressive Antipyretics for Fever Reduction in CNS Malaria

Completed·UUniversity of Rochester·Phase 2·NCT03399318·256 enrolled

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

Unknown status·BBandim Health Project·Phase 4·NCT00137566

Opioid Analgesia2 trials

Nonopioid Analgesia After Rotator Cuff Repair

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

Nonopioid Analgesia After Arthroscopic Meniscus Surgery

Completed·HHenry Ford Health System·Phase 1·NCT03820193·61 enrolled

Injury2 trials

Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis

Completed·VVanderbilt University·Phase 2·NCT01739361·44 enrolled

Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury

Completed·UUniversity of California, San Francisco·Phase 1/2·NCT03496545·47 enrolled

Low back pain2 trials

Ibuprofen With or Without Acetaminophen for Low Back Pain

Completed·MMontefiore Medical Center·Phase 3·NCT03554018·120 enrolled

Safety and Efficacy Study of an Etoricoxib and Tizanidine Fixed Dose Combination in Participants With Moderate to Severe Acute Low Back Pain (MK-0663B-164)

Withdrawn· Merck & Co. logo

Merck & Co.·Phase 3·NCT01979510

Pediatric Patients2 trials

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

Recruiting·—·N/A·NCT06326983·58 enrolled

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

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

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

Hepatic Tumors1 trial

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

Withdrawn·—·Phase 4·NCT02911961

Alzheimer's Disease1 trial

Behavioral Expressions in Alzheimer's Disease

Completed·UUniversity of Florida··NCT02719834·4 enrolled

Gynecologic Surgery1 trial

Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery

Completed·SScripps Health·N/A·NCT03391284·75 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

Tooth Extraction1 trial

Pre-emptive Analgesic Administration in Primary Tooth Extraction

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

Surgery1 trial

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

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

Pulpitis1 trial

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

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

Post Operative Pain1 trial

Supracondylar Post-Operative Pain Study

Recruiting·UUniversity of California, Los Angeles·Phase 4·NCT03759028·90 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

Bariatric Surgery1 trial

Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients

Terminated·TTrinity Health Of New England·N/A·NCT01527942·34 enrolled

Toxicity1 trial

Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity

Unknown status·UUniversity of South Alabama·Phase 1·NCT06214468·40 enrolled

After Cardiac Surgery1 trial

Intravenous Acetaminophen After Cardiac Surgery - Definitive Study

Recruiting·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 4·NCT06613178·1,100 enrolled

Pain Perception1 trial

Preemptive Ibuprofen Effects on Pain Perception Following Extraction and Bone Graft

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

Vertebral Compression Fracture1 trial

Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures

Withdrawn·UUniversity of California, Davis·Phase 4·NCT03651804

Intensive Care Unit1 trial

Safety and Efficacy of Acetaminophen in the Intensive Care Unit.

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

Prevention1 trial

The Prevention of Pain Associated With Rocuronium Injection

Completed·SSuleyman Demirel University·Phase 4·NCT02524743·150 enrolled

Non-Alcoholic Fatty Liver Disease1 trial

The Effect of Acetaminophen on Non-alcoholic Fatty Liver Disease Patients

Withdrawn·UUniversity of Southern California·N/A·NCT02194894

Post-surgical1 trial

A Study of Acetaminophen for Post Surgical Dental Pain

Completed·NNevakar, Inc.·Phase 2·NCT04018612·110 enrolled

CAR1 trial

Evaluation of Broccoli Seed and Sprout Extract for Detoxification of Carcinogens in Firefighters

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06009926·72 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

Caesarean Section1 trial

HTX-011 Administration Study in Planned Caesarean Section Procedure

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

Ketorolac1 trial

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

Completed·—·Phase 2·NCT04646967·100 enrolled

Sprain1 trial

A Safety and Effectiveness Study of Acetaminophen Extended Release (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Pain Associated With Ankle Sprains.

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 4·NCT00261560·260 enrolled

Nerve Block1 trial

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

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

Women1 trial

Research Study to Investigate the Effect of NNC0174-0833 on a Birth Control Pill in Women Who Are Not Able to Become Pregnant

Completed· Novo Nordisk logo

Novo Nordisk·Phase 1·NCT04074174·31 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

Chronic pain1 trial

Acetaminophen for Chronic Pain in Hysterectomy

Completed·MMustafa Kemal University·Phase 4·NCT02086747·140 enrolled

Intravenous1 trial

Opioid-sparing Effect of Intravenous Ibuprofen

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

Melanoma1 trial

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00003346·80 enrolled

Safety and Efficacy1 trial

A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain

Completed· Pfizer logo

Pfizer·Phase 3·NCT02912650·568 enrolled

Idiopathic Nephrotic Syndrome1 trial

A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome

Active, not recruiting· Roche logo

Roche·Phase 3·NCT05627557·85 enrolled

Bunion1 trial

Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

Completed·CConcentric Analgesics·Phase 2·NCT03885596·36 enrolled

Concussion1 trial

Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children

Completed·MMcMaster Children's Hospital·N/A·NCT02268058·80 enrolled

Ambulatory Surgical Procedures1 trial

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures

Withdrawn·UUniversity of California, San Diego·Phase 4·NCT01231191

Postoperative Analgesia1 trial

Post Operative Analgesia and Patient Satisfaction

Completed·LLoma Linda University·Phase 3·NCT04976387·150 enrolled

Concentration1 trial

The Effect of Combination of Mosapride and DPP-4 Inhibitor on Plasma Concentration of Incretin Hormones

Completed·SSeoul National University Hospital·Phase 4·NCT02180334·12 enrolled

Hepatotoxicity1 trial

Acetaminophen-induced Hepatotoxicity in Chronic Alcohol Abusers

Completed·—·N/A·NCT00137059·40 enrolled

Rheumatoid Arthritis1 trial

The Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis

Completed·MMaoxiang Group Jilin Pharmaceutical Co., Ltd.·Phase 2·NCT02029599·240 enrolled

Analgesic Efficacy1 trial

Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients

Completed·—·Phase 3·NCT01394718·67 enrolled

Congenital Heart Disease1 trial

Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

Completed·PPeter Winch··NCT04278625·30 enrolled

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

Diffuse Large B-Cell Lymphoma1 trial

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05211336·14 enrolled

Tachycardia1 trial

Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

Terminated·WWeill Medical College of Cornell University·N/A·NCT00377832·13 enrolled

Mohs Micrographic Surgery1 trial

Meloxicam in Mohs Micrographic Surgery

Recruiting·UUniversity of Oklahoma·Phase 4·NCT07200544·300 enrolled

Multiple Sclerosis1 trial

Aspirin for Exercise in Multiple Sclerosis (ASPIRE)

Completed·—·Phase 3·NCT03824938·60 enrolled

Enhanced Recovery After Surgery1 trial

IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population

Completed·UUnknown Sponsor·Phase 4·NCT03198871·180 enrolled

Lumbar Spine Surgery1 trial

Oral Versus Intravenous Acetaminophen in Lumbar Spine Surgery

Not yet recruiting·SStanford University·Phase 4·NCT07203079·180 enrolled

Critical Care1 trial

Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit

Completed·UUniversity of Utah·Phase 4·NCT01948505·210 enrolled

Aspirin1 trial

Evaluate Onset of Action of a Fast Release Aspirin

Completed· Bayer logo

Bayer·Phase 3·NCT01420094·510 enrolled

Premedication1 trial

Premedication to Reduce Discomfort With Screening Mammography

Completed·MMountain States Tumor and Medical Research Institute·Phase 4·NCT00382083

Cleft Palate1 trial

Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair

Completed·LLoma Linda University·N/A·NCT01500109·45 enrolled

Sepsis1 trial

Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery

Completed·MMassachusetts General Hospital·Phase 2·NCT04291508·488 enrolled

Intrapartum Fever1 trial

Reduction of Intrapartum Fever With Intravenous Acetaminophen

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

Pharyngitis1 trial

A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis

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

Complication1 trial

Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications

Completed·TThe Cleveland Clinic·Phase 3·NCT02156154·580 enrolled

Drug Interactions1 trial

Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen

Completed·MMallinckrodt·Phase 4·NCT02848729·50 enrolled

Dexamethasone1 trial

A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor

Unknown status·HHellenic Society of Hematology·Phase 2·NCT05298683·108 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

Headache1 trial

Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean

Completed·—·Phase 4·NCT03910088·30 enrolled

Cholecystectomy1 trial

Multimodal and Unimodal Analgesia in Cholecystectomy

Completed·OOctober 6 University·Phase 1/2·NCT05547659·95 enrolled

Obese Patients1 trial

Pharmacokinetics of Acetaminophen in Morbidly Obese Patients

Completed·SSt. Antonius Hospital·Phase 4·NCT01764555·28 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

Hysterectomy1 trial

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

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

Patent ductus arteriosus1 trial

Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus

Completed·UUniversity of Florida·Phase 1·NCT03103022·20 enrolled

Sinusitis1 trial

Treatment of Acute Sinusitis

Completed·WWashington University School of Medicine·Phase 4·NCT00377403·172 enrolled

Gastric Emptying1 trial

The Effect of AMG 133 on Gastric Emptying

Completed· Amgen logo

Amgen·Phase 1·NCT07429032·57 enrolled

Delirium1 trial

Intravenous Acetaminophen for Postoperative Delirium in Older Patients Recovering From Major Noncardiac Surgery

Not yet recruiting·RRenJi Hospital·Phase 2/3·NCT06653465·1,930 enrolled

Analgesia1 trial

Pre-Emptive Analgesia in Ano-Rectal Surgery

Completed·UUniversity of Vermont·N/A·NCT02402543·90 enrolled

Phase II1 trial

A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05285813·42 enrolled

Efficacy and Safety1 trial

Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen

Completed·SSaint-Joseph University·Phase 2·NCT03635684·31 enrolled

Allogeneic Hematopoietic Cell Transplant1 trial

Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT02356159·34 enrolled

Gene Therapy1 trial

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT05035407·36 enrolled

Obese1 trial

A Study of Efinopegdutide in Healthy Obese Participants (MK-6024-015)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06701305·48 enrolled

Non-Opioid Pain Management1 trial

SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management

Active, not recruiting·—·Phase 4·NCT06187584·160 enrolled

Perioperative Pain1 trial

Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery

Completed·MMassachusetts General Hospital·Phase 2·NCT05764707·60 enrolled

Hypertension1 trial

Hypertension In Postpartum Preeclampsia Study

Completed·MMemorialCare Health System·N/A·NCT03011567·202 enrolled

Stem Cell Transplantation1 trial

Stem Cell Transplantation in Crohn's Disease

Recruiting·—·Phase 1/2·NCT04224558·15 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

Papilloma1 trial

E7 TCR T Cells for Human Papillomavirus-Associated Cancers

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

Anterior Cruciate Ligament Reconstruction1 trial

Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction

Completed·HHenry Ford Health System·Phase 2/3·NCT03818932·90 enrolled

Pain Intensity1 trial

Reduction in Pain Intensity Following IV or Oral Pain-relieving Products

Completed·MMallinckrodt·Phase 4·NCT02678416·79 enrolled

Delayed Onset Muscle Soreness1 trial

A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness

Completed·JJean Brown Research·Phase 4·NCT02113566·60 enrolled

Advanced1 trial

Decreasing Narcotics in Advanced Pelvic Surgery

Completed·HHartford Hospital·Phase 4·NCT02110719·138 enrolled

Small Bowel Obstruction1 trial

A Study of Intravenous Acetaminophen for Small Bowel Obstruction

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

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

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

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

Radiofrequency Ablation1 trial

Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer

Completed·IInstitut Bergonié·Phase 2·NCT00712712·78 enrolled

Oocyte Retrieval1 trial

Rectal Acetaminophen Use During Oocyte Retrievals to Reduce Post-Operative Opioid Utilization

Terminated·UUniversity of South Florida·Phase 4·NCT03732469·4 enrolled

Unspecified2 trials

Postoperative Effects of TAP Block Versus QLB Type 2 Block

Completed·—·Phase 4·NCT03126084·90 enrolled

The Effects of Hydromorphone on Responses to Verbal Tasks

Completed·UUniversity of Chicago·N/A·NCT02205983·50 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

Jun 8, 1994

TYLENOL

NDA NDA019872

Jan 5, 1995

TYLENOL

NDA NDA019872

Jul 28, 1995

TYLENOL

NDA NDA019872

Aug 1, 1995

TYLENOL

NDA NDA019872

Jul 25, 2000

TYLENOL

NDA NDA019872

Jul 25, 2000

TYLENOL

NDA NDA019872

Jan 11, 2001

TYLENOL

NDA NDA019872

Feb 12, 2001

TYLENOL

NDA NDA019872

May 28, 2003

TYLENOL

NDA NDA019872

May 28, 2003

TYLENOL

NDA NDA019872

May 29, 2003

TYLENOL

NDA NDA019872

Aug 1, 2003

TYLENOL

NDA NDA019872

Mar 22, 2004

TYLENOL

NDA NDA019872

Apr 13, 2004

TYLENOL

NDA NDA019872

Nov 3, 2004

TYLENOL

NDA NDA019872

Feb 28, 2008

TYLENOL

NDA NDA019872

Jun 17, 2009

TYLENOL

NDA NDA019872

Sep 18, 2009

TYLENOL

NDA NDA019872

May 6, 2010

TYLENOL

NDA NDA019872

May 10, 2010

TYLENOL

NDA NDA019872

Nov 2, 2010

OFIRMEV

NDA NDA022450

Dec 23, 2011

TYLENOL

NDA NDA019872

Mar 26, 2013

TYLENOL

NDA NDA019872

Mar 28, 2013

TYLENOL

NDA NDA019872

Dec 20, 2013

TYLENOL

NDA NDA019872

Mar 6, 2014

TYLENOL

NDA NDA019872

Dec 12, 2014

TYLENOL

NDA NDA019872

Dec 23, 2014

TYLENOL

NDA NDA019872

Oct 28, 2015

ACETAMINOPHEN

NDA NDA204767

May 5, 2016

TYLENOL

NDA NDA019872

Aug 26, 2016

TYLENOL

NDA NDA019872

Jan 16, 2019

TYLENOL

NDA NDA019872

Apr 16, 2019

ACETAMINOPHEN

NDA ANDA211544

Jan 15, 2021

ACETAMINOPHEN

NDA NDA206610

Feb 18, 2021

ACETAMINOPHEN

NDA NDA204957

Jun 3, 2022

ACETAMINOPHEN

NDA NDA206968

Feb 28, 2023

ACETAMINOPHEN AND IBUPROFEN

NDA ANDA214836

Jan 18, 2024

ACETAMINOPHEN

NDA ANDA211544

Oct 22, 2025

ACETAMINOPHEN AND IBUPROFEN

NDA ANDA214836

Oct 22, 2025

ACETAMINOPHEN AND IBUPROFEN

NDA ANDA214836

Oct 22, 2025

ACETAMINOPHEN AND IBUPROFEN

NDA ANDA214836

Sources

References

[1]
ClinicalTrials.gov — 469 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 ANDA214836). 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

Tylenol

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Acetaminophen36 trials

Tonsillectomy4 trials

Postoperative Pain Control4 trials

Multiple Myeloma4 trials

Spinal Fusion3 trials

Cesarean Section3 trials

Osteoarthritis3 trials

Pain Management3 trials

Transplantation2 trials

Patient Satisfaction2 trials

Kidney Transplant2 trials

Phase 22 trials

Total Hip Arthroplasty2 trials

Prospective2 trials

Laparoscopic2 trials

Shoulder Arthroplasty2 trials

Sinus Surgery2 trials

Multimodal Analgesia2 trials

Postoperative Pain Management2 trials

Leukemia2 trials

Drug Metabolism2 trials

Dysmenorrhea2 trials

Hepatic Function2 trials

Malaria2 trials

Opioid Analgesia2 trials

Injury2 trials

Low back pain2 trials

Pediatric Patients2 trials

Lupus Nephritis1 trial

Acute Dental Pain1 trial

Epidural Analgesia1 trial

Hepatic Tumors1 trial

Alzheimer's Disease1 trial

Gynecologic Surgery1 trial

Pompe Disease1 trial

Tooth Extraction1 trial

Surgery1 trial

Pulpitis1 trial

Post Operative Pain1 trial

Opioid Use1 trial

Bariatric Surgery1 trial

Toxicity1 trial

After Cardiac Surgery1 trial

Pain Perception1 trial

Vertebral Compression Fracture1 trial

Intensive Care Unit1 trial

Prevention1 trial

Non-Alcoholic Fatty Liver Disease1 trial

Post-surgical1 trial

CAR1 trial

Systemic Lupus Erythematosus1 trial

Caesarean Section1 trial

Ketorolac1 trial

Sprain1 trial

Nerve Block1 trial

Women1 trial

Solid Tumors1 trial

Chronic pain1 trial

Intravenous1 trial

Donor1 trial

Melanoma1 trial

Safety and Efficacy1 trial

Idiopathic Nephrotic Syndrome1 trial

Bunion1 trial

Concussion1 trial

Ambulatory Surgical Procedures1 trial

Postoperative Analgesia1 trial

Concentration1 trial

Hepatotoxicity1 trial

Rheumatoid Arthritis1 trial

Analgesic Efficacy1 trial

Congenital Heart Disease1 trial

ART1 trial