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Diclofenac sodium active topical patch
Diclofenac sodium active topical patch is a Nonsteroidal anti-inflammatory drug (NSAID) Small molecule drug developed by Noven Pharmaceuticals, Inc.. It is currently in Phase 3 development for Localized pain and inflammation associated with minor strains, sprains, and contusions, Osteoarthritis pain (localized). Also known as: HP-5000.
Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain when applied topically.
Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain when applied topically. Used for Localized pain and inflammation associated with minor strains, sprains, and contusions, Osteoarthritis pain (localized).
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Diclofenac sodium active topical patch |
|---|---|
| Also known as | HP-5000 |
| Sponsor | Noven Pharmaceuticals, Inc. |
| Drug class | Nonsteroidal anti-inflammatory drug (NSAID) |
| Target | Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) |
| Modality | Small molecule |
| Therapeutic area | Pain Management / Rheumatology |
| Phase | Phase 3 |
Mechanism of action
Diclofenac sodium works by blocking COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. When formulated as a topical patch, the drug is delivered directly to affected tissues, allowing local anti-inflammatory and analgesic effects while minimizing systemic exposure compared to oral formulations. This localized delivery approach reduces the risk of gastrointestinal and cardiovascular adverse effects associated with systemic NSAID use.
Approved indications
- Localized pain and inflammation associated with minor strains, sprains, and contusions
- Osteoarthritis pain (localized)
Common side effects
- Application site reactions (erythema, pruritus, irritation)
- Headache
- Gastrointestinal upset (if systemic absorption occurs)
Key clinical trials
- A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee (PHASE3)
- A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis (PHASE2)
- A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis (PHASE3)
- Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain (PHASE3)
- Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED) (PHASE3)
- Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain (PHASE3)
- Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion (PHASE3)
- Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain (PHASE2, PHASE3)
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:
- Diclofenac sodium active topical patch CI brief — competitive landscape report
- Diclofenac sodium active topical patch updates RSS · CI watch RSS
- Noven Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about Diclofenac sodium active topical patch
What is Diclofenac sodium active topical patch?
How does Diclofenac sodium active topical patch work?
What is Diclofenac sodium active topical patch used for?
Who makes Diclofenac sodium active topical patch?
Is Diclofenac sodium active topical patch also known as anything else?
What drug class is Diclofenac sodium active topical patch in?
What development phase is Diclofenac sodium active topical patch in?
What are the side effects of Diclofenac sodium active topical patch?
What does Diclofenac sodium active topical patch target?
Related
- Drug class: All Nonsteroidal anti-inflammatory drug (NSAID) drugs
- Target: All drugs targeting Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2)
- Manufacturer: Noven Pharmaceuticals, Inc. — full pipeline
- Therapeutic area: All drugs in Pain Management / Rheumatology
- Indication: Drugs for Localized pain and inflammation associated with minor strains, sprains, and contusions
- Indication: Drugs for Osteoarthritis pain (localized)
- Also known as: HP-5000
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing