IV acetaminophen

Phase 3Small molecule

AAFT Pharmaceuticals, Ltd.

IV acetaminophen is one of 78 small molecule programs targeting Pregnant Women. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Pregnant WomenTerminated

IntraoperativeCompleted

Opioid AnalgesiaCompleted

DeliriumActive, not recruiting

Extracorporeal Shockwave LithotripsyNot yet recruiting

Pregnant WomenPreclinical

Terminated

IntraoperativePreclinical

Completed

Opioid AnalgesiaPreclinical

Completed

DeliriumPhase 3

Active, not recruiting

Extracorporeal Shockwave LithotripsyPhase 3

Not yet recruiting

Competition

Competitive Landscape

78 competitors in Delirium

#DrugCompanyPhaseTrials

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

58 2

Rozerem

Takeda

Approved

6 3

Exelon

Novartis

Approved

6 4

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Approved

10 5

Voltaren

Novartis

Approved

1 6

Aleve

Jazz Pharmaceuticals

Approved

1 7

Duragesic

CCephalon

Approved

7 8

Anerem

AAcacia Pharma Ltd

Approved

5 9

Spravato

WWim Janssens

Approved

4 10

Belsomra

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

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

Timeline

Expected Milestones

Q1 2027

Post-ApprovalNot yet recruiting

Extracorporeal Shockwave Lithotripsy

NCT07368738

Clinical

Trials by Indication[1]

Acetaminophen10 trials

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

Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients

Completed·MMallinckrodt·Phase 3·NCT00598702·100 enrolled

IV Acetaminophen in Children Undergoing Palatoplasty

Withdrawn·NNationwide Children's Hospital·Phase 2·NCT01760330

Show 7 more trials

Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients

Completed·MMallinckrodt·Phase 1·NCT00493246·75 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

Efficacy of Acetaminophen in Posterior Fossa Surgery

Withdrawn·—·Phase 2·NCT02532322

Preoperative IV Versus Oral Acetaminophen

Completed·TTriHealth Inc.·Phase 4·NCT03468920·120 enrolled

Equality Study of Ofirmev vs Oral Acetaminophen

Unknown status·—·Phase 4·NCT01711229·114 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

Safety of Intravenous Acetaminophen Vs Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males

Completed·MMallinckrodt·Phase 3·NCT00493311·60 enrolled

Opioid Consumption2 trials

Decrease Opioid Consumption With Intra-Venous (IV) Acetaminophen After Colorectal Surgery (DOCIVA)

Completed·—·N/A·NCT02804633·105 enrolled

Intravenous Acetaminophen to Reduce Post-operative Opioid Consumption

Not yet recruiting·—·Phase 4·NCT06923540·140 enrolled

Analgesic Efficacy2 trials

Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery

Completed·WWeill Medical College of Cornell University·Phase 4·NCT01783236·16 enrolled

Analgesic Efficacy & Safety of Intravenous (IV) Acetaminophen Versus Placebo for the Treatment of Postop Pain

Completed·MMallinckrodt·Phase 3·NCT00564486·244 enrolled

Randomized Controlled Trial2 trials

RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief

Completed·TTriHealth Inc.·Phase 4·NCT02046382·132 enrolled

RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain

Completed·TTriHealth Inc.·Phase 4·NCT02043704·100 enrolled

Agitation1 trial

Emergence Agitation and Pain Scores in Pediatrics When Comparing Single-modal vs Multi-modal Analgesia for ENT Surgery

Completed·NNemours Children's Clinic·Phase 1·NCT03062488·143 enrolled

29 more indications

Bunion1 trial

Maxigesic IV Phase 3 Bunionectomy Study

Completed·AAFT Pharmaceuticals, Ltd.·Phase 3·NCT02689063·276 enrolled

Postoperative Quality of Recovery1 trial

Perioperative Systemic Acetaminophen to Improve Postoperative Quality of Recovery After Ambulatory Breast Surgery

Completed·NNorthwestern University·N/A·NCT01852955·70 enrolled

Perioperative Pain Control1 trial

Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval

Completed·MMassachusetts General Hospital·Phase 4·NCT03073980·161 enrolled

Dexamethasone1 trial

Comparison of Exparel to Bupivacaine With Dexamethasone in TAP Block

Terminated·—·Phase 4·NCT02179892·9 enrolled

Drug Interactions1 trial

Drug Interactions Between Morphine and Orally or IV Administered Acetaminophen

Completed·MMallinckrodt·Phase 4·NCT02848729·50 enrolled

Nausea and vomiting1 trial

Acetaminophen vs Placebo in the Pre-operative Setting and Outcomes on Post-operative Pain, Nausea and Vomiting

Terminated·MMercyOne Des Moines Medical Center·Phase 3·NCT02102555·82 enrolled

Post Operative Pain1 trial

Acetaminophen's Efficacy For Post-operative Pain

Completed·—·Phase 4·NCT01721486·41 enrolled

Extracorporeal Shockwave Lithotripsy1 trial

Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy

Not yet recruiting·HHorizon Health Network·Phase 4·NCT07368738·266 enrolled

Intraoperative1 trial

Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery

Completed·TThe University of Texas Health Science Center, Houston·N/A·NCT01608308·62 enrolled

Pediatric Patients1 trial

A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients

Completed·MMallinckrodt·Phase 3·NCT01635101·197 enrolled

Pain Management1 trial

Efficacy of IV Acetaminophen for Pain Management

Completed·AAultman Health Foundation·Phase 4·NCT02028715·68 enrolled

Pain Intensity1 trial

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

Completed·MMallinckrodt·Phase 4·NCT02678416·79 enrolled

Procedural Pain1 trial

Effectiveness of IV Acetaminophen and IV Ibuprofen in Reducing Post Procedural Pain in the UFE Procedure

Completed·UUniversity of California, Los Angeles·Phase 4·NCT02227316·40 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery

Completed·MMallinckrodt·Phase 3·NCT00399568·331 enrolled

Gastric Bypass Surgery1 trial

Efficacy of IV Acetaminophen in Acute Post-Operative Pain Control in Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP) Patients

Unknown status·—·N/A·NCT01460667·85 enrolled

Advanced1 trial

Decreasing Narcotics in Advanced Pelvic Surgery

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

Acute Postoperative Pain1 trial

IV Acetaminophen for Acute Post Operative Pain in C-Section Patients

Completed·MMontefiore Medical Center·Phase 4·NCT02069184·66 enrolled

Cardiac Surgery1 trial

IV Acetaminophen as an Adjunct Analgesic in Cardiac Surgery

Completed·UUniversity of Washington·Phase 4·NCT01544062·68 enrolled

Opioid Analgesia1 trial

Opioid Based Analgesia vs Non-opioid Analgesia for Oocyte Retrieval Procedure

Completed·TTel-Aviv Sourasky Medical Center·N/A·NCT04933058·100 enrolled

Delirium1 trial

PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients

Active, not recruiting·—·Phase 3·NCT04093219·900 enrolled

Coronary Artery Bypass1 trial

Pain Control After Minimally Invasive Coronary Artery Bypass Grafting

Terminated·GGundersen Lutheran Medical Foundation·Phase 4·NCT01770236·41 enrolled

Hysterectomy1 trial

IV Acetaminophen for Postoperative Pain Analgesia After Laparoscopic Hysterectomy

Completed·UUniversity of Pittsburgh·Phase 4·NCT02400580·183 enrolled

Hip Fracture1 trial

Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?

Terminated·CCorewell Health West·Phase 4·NCT02774148·1 enrolled

Postoperative Analgesia1 trial

IV Acetaminophen for Postoperative Analgesia

Terminated·NNorthwell Health·Phase 4·NCT01798316·105 enrolled

Pregnant Women1 trial

IV Acetaminophen vs IV Morphine for Pain Control in Pregnant Women

Terminated·TThe University of Texas Health Science Center, Houston·N/A·NCT02267772·163 enrolled

After Cardiac Surgery1 trial

Pain Control After Cardiac Surgery Using Intravenous Acetaminophen

Completed·TThe Cleveland Clinic·N/A·NCT01822821·150 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients

Completed·MMallinckrodt·Phase 3·NCT00598559·213 enrolled

Emergency Department Patient1 trial

IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients

Completed·—·Phase 3·NCT03553498·162 enrolled

Pelvic Organ Prolapse1 trial

IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair

Completed·—·Phase 4·NCT02155738·204 enrolled

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for IV acetaminophen. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — IV acetaminophen compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for IV acetaminophen. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AFT Pharmaceuticals, Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAFT Pharmaceuticals, Ltd.

IV acetaminophen

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

Acetaminophen10 trials

Opioid Consumption2 trials

Analgesic Efficacy2 trials

Randomized Controlled Trial2 trials

Agitation1 trial

Bunion1 trial

Postoperative Quality of Recovery1 trial

Perioperative Pain Control1 trial

Dexamethasone1 trial

Drug Interactions1 trial

Nausea and vomiting1 trial

Post Operative Pain1 trial

Extracorporeal Shockwave Lithotripsy1 trial

Intraoperative1 trial

Pediatric Patients1 trial

Pain Management1 trial

Pain Intensity1 trial

Procedural Pain1 trial

Efficacy and Safety1 trial

Gastric Bypass Surgery1 trial

Advanced1 trial

Acute Postoperative Pain1 trial

Cardiac Surgery1 trial

Opioid Analgesia1 trial

Delirium1 trial

Coronary Artery Bypass1 trial

Hysterectomy1 trial

Hip Fracture1 trial

Postoperative Analgesia1 trial

Pregnant Women1 trial

After Cardiac Surgery1 trial

Safety and Efficacy1 trial

Emergency Department Patient1 trial

Pelvic Organ Prolapse1 trial

References

Drug Info

Quick Facts

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