Last reviewed 2026-05-26 · How we verify

Diclofenac Sodium Active Topical Patch 1

Noven Pharmaceuticals, Inc. · Phase 2 active Small molecule Under review Quality 0/100

Diclofenac Sodium Active Topical Patch 1 is a NSAID Small molecule drug developed by Noven Pharmaceuticals, Inc.. It is currently in Phase 2 development for Pain relief, Inflammation. Also known as: HP-5000.

Diclofenac Sodium is a non-selective COX-2 inhibitor.

Diclofenac Sodium Active Topical Patch 1 is used to treat conditions such as rotator cuff tendonitis, bicipital tendonitis, subdeltoid bursitis of the shoulder, subacromial bursitis of the shoulder, and medial epicondylitis of the elbow. It works by inhibiting cyclooxygenase, an enzyme involved in the production of prostaglandins, which are associated with pain and inflammation.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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 1
Also known as	HP-5000
Sponsor	Noven Pharmaceuticals, Inc.
Drug class	NSAID
Target	COX-2
Modality	Small molecule
Therapeutic area	Pain Management
Phase	Phase 2

Mechanism of action

Diclofenac Sodium works by inhibiting the enzyme cyclooxygenase-2 (COX-2), which is involved in the production of prostaglandins, leading to pain relief and anti-inflammatory effects.

Approved indications

Pain relief
Inflammation

Common side effects

Gastrointestinal upset
Dizziness
Headache

Key clinical trials

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 1 CI brief — competitive landscape report
Diclofenac Sodium Active Topical Patch 1 updates RSS · CI watch RSS
Noven Pharmaceuticals, Inc. portfolio CI

Frequently asked questions about Diclofenac Sodium Active Topical Patch 1

What is Diclofenac Sodium Active Topical Patch 1?

Diclofenac Sodium Active Topical Patch 1 is a NSAID drug developed by Noven Pharmaceuticals, Inc., indicated for Pain relief, Inflammation.

How does Diclofenac Sodium Active Topical Patch 1 work?

Diclofenac Sodium is a non-selective COX-2 inhibitor.

What is Diclofenac Sodium Active Topical Patch 1 used for?

Diclofenac Sodium Active Topical Patch 1 is indicated for Pain relief, Inflammation.

Who makes Diclofenac Sodium Active Topical Patch 1?

Diclofenac Sodium Active Topical Patch 1 is developed by Noven Pharmaceuticals, Inc. (see full Noven Pharmaceuticals, Inc. pipeline at /company/noven-pharmaceuticals-inc).

Is Diclofenac Sodium Active Topical Patch 1 also known as anything else?

Diclofenac Sodium Active Topical Patch 1 is also known as HP-5000.

What drug class is Diclofenac Sodium Active Topical Patch 1 in?

Diclofenac Sodium Active Topical Patch 1 belongs to the NSAID class. See all NSAID drugs at /class/nsaid.

What development phase is Diclofenac Sodium Active Topical Patch 1 in?

Diclofenac Sodium Active Topical Patch 1 is in Phase 2.

What are the side effects of Diclofenac Sodium Active Topical Patch 1?

Common side effects of Diclofenac Sodium Active Topical Patch 1 include Gastrointestinal upset, Dizziness, Headache.

What does Diclofenac Sodium Active Topical Patch 1 target?

Diclofenac Sodium Active Topical Patch 1 targets COX-2 and is a NSAID.

Drug class: All NSAID drugs
Target: All drugs targeting COX-2
Manufacturer: Noven Pharmaceuticals, Inc. — full pipeline
Therapeutic area: All drugs in Pain Management
Indication: Drugs for Pain relief
Indication: Drugs for Inflammation
Also known as: HP-5000

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing