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PN 400 (VIMOVO)
PN 400 (VIMOVO) is a NSAID-proton pump inhibitor combination Small molecule drug developed by POZEN. It is currently in Phase 3 development for Treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Also known as: Naprosyn, Nexium, PN 400, PN400.
VIMOVO combines the NSAID ibuprofen with the proton pump inhibitor omeprazole to reduce gastrointestinal side effects associated with NSAID therapy.
PN 400 (VIMOVO) is a small molecule used in the treatment of osteoarthritis. It has also been studied in relation to gastric ulcers.
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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 | PN 400 (VIMOVO) |
|---|---|
| Also known as | Naprosyn, Nexium, PN 400, PN400 |
| Sponsor | POZEN |
| Drug class | NSAID-proton pump inhibitor combination |
| Modality | Small molecule |
| Therapeutic area | Gastrointestinal |
| Phase | Phase 3 |
Mechanism of action
By combining an NSAID with a proton pump inhibitor, VIMOVO aims to reduce the risk of gastrointestinal complications such as ulcers and bleeding, which are common side effects of NSAID therapy. This is particularly important for patients who require long-term NSAID treatment for conditions like osteoarthritis or rheumatoid arthritis.
Approved indications
- Treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis
Common side effects
- Gastrointestinal bleeding
- Abdominal pain
- Nausea
Key clinical trials
- Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis (PHASE3)
- Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis (PHASE3)
- Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen (PHASE3)
- Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen (PHASE3)
- Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec (PHASE3)
- A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO) (PHASE3)
- Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone (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:
- PN 400 (VIMOVO) CI brief — competitive landscape report
- PN 400 (VIMOVO) updates RSS · CI watch RSS
- POZEN portfolio CI
Frequently asked questions about PN 400 (VIMOVO)
What is PN 400 (VIMOVO)?
How does PN 400 (VIMOVO) work?
What is PN 400 (VIMOVO) used for?
Who makes PN 400 (VIMOVO)?
Is PN 400 (VIMOVO) also known as anything else?
What drug class is PN 400 (VIMOVO) in?
What development phase is PN 400 (VIMOVO) in?
What are the side effects of PN 400 (VIMOVO)?
Related
- Drug class: All NSAID-proton pump inhibitor combination drugs
- Manufacturer: POZEN — full pipeline
- Therapeutic area: All drugs in Gastrointestinal
- Indication: Drugs for Treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis
- Also known as: Naprosyn, Nexium, PN 400, PN400
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing