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Commercial acetaminophen
Commercial acetaminophen is a Analgesic and antipyretic Small molecule drug developed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. It is currently in Phase 3 development for Mild to moderate pain, Fever reduction. Also known as: Commercial ACM.
Acetaminophen reduces pain and fever by inhibiting prostaglandin synthesis in the central nervous system.
Acetaminophen reduces pain and fever by inhibiting prostaglandin synthesis in the central nervous system. Used for Mild to moderate pain, Fever reduction.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Commercial acetaminophen |
|---|---|
| Also known as | Commercial ACM |
| Sponsor | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division |
| Drug class | Analgesic and antipyretic |
| Target | Cyclooxygenase (COX), primarily in central nervous system |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Acetaminophen is believed to work primarily through inhibition of cyclooxygenase (COX) enzymes in the brain and spinal cord, reducing the production of prostaglandins that mediate pain and fever signaling. Unlike NSAIDs, it has minimal peripheral anti-inflammatory effects. The exact mechanism remains incompletely understood, but central nervous system effects on pain perception and thermoregulation are well-established.
Approved indications
- Mild to moderate pain
- Fever reduction
Common side effects
- Hepatotoxicity (at high doses or chronic use)
- Rash
- Nausea
Key clinical trials
- A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (PHASE2)
- A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (PHASE2)
- SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM (PHASE3)
- Efficacy of IV Acetaminophen Versus Oral Acetaminophen (PHASE4)
- Effects of Gum Chewing on Appetite and Digestion (NA)
- Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study (PHASE2)
- Study of Acetaminophen (ACM) in Post-operative Dental Pain (PHASE3)
- Study of Venetoclax Plus DA-EPOCH-R for the Treatment of Aggressive B-Cell Lymphomas (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Commercial acetaminophen CI brief — competitive landscape report
- Commercial acetaminophen updates RSS · CI watch RSS
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division portfolio CI
Frequently asked questions about Commercial acetaminophen
What is Commercial acetaminophen?
How does Commercial acetaminophen work?
What is Commercial acetaminophen used for?
Who makes Commercial acetaminophen?
Is Commercial acetaminophen also known as anything else?
What drug class is Commercial acetaminophen in?
What development phase is Commercial acetaminophen in?
What are the side effects of Commercial acetaminophen?
What does Commercial acetaminophen target?
Related
- Drug class: All Analgesic and antipyretic drugs
- Target: All drugs targeting Cyclooxygenase (COX), primarily in central nervous system
- Manufacturer: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Mild to moderate pain
- Indication: Drugs for Fever reduction
- Also known as: Commercial ACM
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing