Ozmosi | Acetaminophen Drug Profile
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Acetaminophen

Alternative Names: acetaminophen, Paracetamol, Panadol, jns013, jns-013, jns 013, ofirmev, acephen, tylenol, neopap, infants' feverall, injectapap, apadaz, tencon, trezix, percocet, norco, lortab, allzital, esgic, ultracet, anoquan, bancap hc, co-gesic, allay, bancap, lorcet-hd, medigesic plus, bucet, roxilox, tylenol w/ codeine no. 4, phenaphen w/ codeine no. 3, fioricet w/ codeine, dhc plus, phenaphen w/ codeine no. 4, phrenilin forte, esgic-plus, triad, tylox, tylenol w/ codeine no. 3, proval #3, roxicet, xartemis xr, anexsia, drixoral plus, capital and codeine, darvocet, codrix, triaprin, anexsia 5/325, darvocet-n 100, darvocet-n 50, femcet, duradyne dhc, phenaphen w/ codeine no. 2, phenaphen-650 w/ codeine, norcet, roxicet 5/500, synalgos-dc-a, talacen, tylox-325, tylenol w/ codeine, vicodin, tycolet, zyfrel, zydone, papa-deine #3, sedapap, anexsia 7.5/650, anexsia 7.5/325, butapap, tylenol w/ codeine no. 2, vicodin hp, dolene ap-65, darvocet a500, oxycet, excedrin (migraine), papa-deine #4, phrenilin, hy-phen, wygesic, vicodin es, propacet 100, tylenol w/ codeine no. 1, endocet, tylenol with codeine, excedrin migraine, fioricet with codeine, zamicet, fioricet, zebutal, nalocet, prolate, bupap, codamol
Clinical Status: Inactive
Latest Update: 2026-07-30
Latest Update Note: Clinical Trial Update

Product Description

Acetaminophen is a widely used nonprescription analgesic and antipyretic medication for mild-to-moderate pain and fever. Harmless at low doses, acetaminophen has direct hepatotoxic potential when taken as an overdose and can cause acute liver injury and death from acute liver failure. Even in therapeutic doses, acetaminophen can cause transient serum aminotransferase elevations. Acetaminophen is a p-aminophenol derivative with analgesic and antipyretic activities. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Acetaminophen)

Mechanisms of Action: COX2 Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral, Intravenous

FDA Designation: *

Approval Status: Approved

Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam

Approved Indications: None

Company: Johnson & Johnson
Company Location:
Company Founding Year: None
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Acetaminophen

Countries in Clinic: Australia, Brazil, Canada, China, Denmark, France, Germany, Greece, Ireland, Italy, Mexico, Poland, Qatar, South Korea, Spain, United Kingdom, United States

Active Clinical Trial Count: 32

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Acute Pain|Arthralgia|Bunion|Common Cold|Influenza, Human|Low Back Pain|Lupus Erythematosus, Systemic|Lupus Nephritis|Osteoarthritis|Osteoarthritis, Hip|Osteoarthritis, Knee|Pain Unspecified|Pain, Postoperative|Toothache

Phase 2: Chronic Pain|Ductus Arteriosus, Patent|Multiple Myeloma|Type 1 Diabetes

Phase 1: Arthritis|Back Pain|Cancer Pain|Depressive Disorder|Diffuse Large B-Cell Lymphoma|Follicular Lymphoma|Headache|Healthy Volunteers|Lymphoma, Non-Hodgkin|Muscle Cramp|Obesity|Other|Overweight

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

2023-505226-33-00

PTG007DM1preTREG001

P2

Recruiting

Type 1 Diabetes

2032-10-31

55%

2025-05-02

Treatments

NCT04702256

OBILUP

P3

Recruiting

Lupus Erythematosus, Systemic|Lupus Nephritis

2031-12-01

2021-12-11

jRCT2051250248

jRCT2051250248

P1

Not yet recruiting

Lymphoma, Non-Hodgkin|Diffuse Large B-Cell Lymphoma|Follicular Lymphoma

2030-06-06

2022-503063-15-00

CARTemis-1

P2

Not yet recruiting

Multiple Myeloma

2030-03-31

2025-05-02

Treatments

2024-510792-38-01

2024-510792-38-01

P3

Withdrawn

Pain Unspecified

2029-03-01

2025-05-02

Treatments

NCT07225140

AFT-MX-16p

P3

Not yet recruiting

Acute Pain|Pain, Postoperative

2027-10-01

50%

2026-07-02

Primary Endpoints

2025-521578-32-00

DI-OR-PA

P3

Not yet recruiting

Low Back Pain

2027-03-31

NCT07225634

AFT-MXIV-08p

P3

Not yet recruiting

Acute Pain

2027-03-01

5%

2026-07-02

NCT05742763

PRPNSAIDsKOA

P2

Recruiting

Osteoarthritis, Knee|Chronic Pain

2026-12-31

2024-04-04

Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status

2023-503209-13-00

2023-503209-13-00

P2

Recruiting

Ductus Arteriosus, Patent

2026-03-30

2025-05-02

Treatments

NCT07269756

HRS-7535-110

P1

Completed

Overweight|Obesity

2026-03-08

2026-04-16

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status

NCT06863636

PRECEDENT

P3

Recruiting

Osteoarthritis, Hip|Arthralgia|Osteoarthritis, Knee

2025-10-30

2025-03-08

Primary Endpoints|Treatments

NCT05831449

CPL-01-302

P3

Completed

Pain, Postoperative|Bunion

2025-09-25

8%

2026-05-01

Primary Endpoints

NCT05118672

RESFRIN

P3

Completed

Common Cold

2025-08-26

2025-09-23

2022-003559-32

2022-003559-32

P3

Completed

Influenza, Human

2024-12-04

2025-05-06

Primary Completion Date|Study Completion Date|Treatments|Trial Status

ACTRN12621000694819

ACTRN12621000694819

P3

Completed

Osteoarthritis

2024-09-06

2025-11-20

Treatments

NCT05761574

CCSPAA005199

P3

Completed

Toothache

2024-05-17

2024-07-23

Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments|Trial Status

CTR20234112

CTR20234112

P1

Completed

Chronic Pain|Cancer Pain

2024-04-08

2025-04-29

Primary Completion Date

NCT04123717

IRB 16206/16

P1

Completed

Other

2024-03-07

2024-08-15

Primary Endpoints

2024-510792-38-00

2024-510792-38-00

P3

Withdrawn

Pain Unspecified

2029-03-01

2025-05-02

Treatments

NCT07429032

NCT07429032

P1

Completed

Overweight|Obesity

2025-11-26

2026-02-25

Primary Endpoints|Treatments

CTR20250869

CTR20250869

P3

Completed

Pain, Postoperative

2025-11-10

2026-01-11

Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status

NCT05813847

CPL-01-301

P3

Completed

Pain, Postoperative

2025-09-15

8%

2026-05-01

Primary Endpoints|Treatments

NCT06855576

NCT06855576

P1

Completed

Healthy Volunteers|Pain Unspecified

2025-04-17

2025-05-07

Patient Enrollment|Primary Endpoints|Treatments|Trial Status

2013-001842-33

PreParaS

P2

Completed

Unknown

2024-08-08

2025-05-06

Primary Completion Date|Study Completion Date|Treatments|Trial Status