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Nitronaproxen (NAPROXCINOD)
Nitronaproxen (generic name: NAPROXCINOD) is a naproxcinod drug. It is currently in Phase 3 development.
Nitronaproxen is a prodrug that is converted to naproxen, a nonsteroidal anti-inflammatory drug (NSAID), which works by inhibiting the enzyme cyclooxygenase (COX), thereby reducing the production of prostaglandins and relieving pain and inflammation.
Nitronaproxen, also known as Naproxcinod, is a small molecule drug in the naproxcinod class. It is a prodrug that is metabolized to naproxen, a nonsteroidal anti-inflammatory drug (NSAID), which is the active moiety responsible for its therapeutic effects. Naproxcinod is not FDA-approved for any indications, and its commercial status is unknown. As a prodrug, it is designed to reduce gastrointestinal side effects associated with NSAIDs. However, its clinical development and safety profile are not well-documented.
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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).
| 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 | NAPROXCINOD |
|---|---|
| Drug class | naproxcinod |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 3 |
Mechanism of action
Imagine your body's pain and inflammation response like a fire. Prostaglandins are like the fuel that keeps the fire burning. Naproxen works by putting out the fire by reducing the production of prostaglandins, which helps to relieve pain and inflammation.
Approved indications
Common side effects
Key clinical trials
- A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer (PHASE2)
- Pharmacokinetics Study: Determination of Naproxcinod and Its Metabolites After Oral Administration in Male (PHASE1)
- A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure (PHASE1)
- Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee (PHASE3)
- Effect of Repeated Dosing of Naproxcinod on Renal Hemodynamic and on Sodium Balance in Healthy Volunteers Before and After a Single Dose of Furosemide (PHASE1)
- To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension (PHASE1)
- Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee (PHASE3)
- A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects (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:
- Nitronaproxen CI brief — competitive landscape report
- Nitronaproxen updates RSS · CI watch RSS
Frequently asked questions about Nitronaproxen
What is Nitronaproxen?
How does Nitronaproxen work?
What is the generic name of Nitronaproxen?
What drug class is Nitronaproxen in?
What development phase is Nitronaproxen in?
Related
- Drug class: All naproxcinod drugs
- Therapeutic area: All drugs in Pain
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing