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NGX-4010, 8% capsaicin patch
NGX-4010, 8% capsaicin patch is a Topical analgesic Small molecule drug developed by NeurogesX. It is currently in Phase 3 development for Postherpetic neuralgia. Also known as: the brandname of NGX-4010, 8% capsaicin patch is Qutenza., The brandname of NGX-4010, 8% capsaicin patch is Qutenza..
NGX-4010, an 8% capsaicin patch, works by activating TRPV1 receptors to reduce pain.
NGX-4010, an 8% capsaicin patch, works by activating TRPV1 receptors to reduce pain. Used for Postherpetic neuralgia.
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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 | NGX-4010, 8% capsaicin patch |
|---|---|
| Also known as | the brandname of NGX-4010, 8% capsaicin patch is Qutenza., The brandname of NGX-4010, 8% capsaicin patch is Qutenza. |
| Sponsor | NeurogesX |
| Drug class | Topical analgesic |
| Target | TRPV1 |
| Modality | Small molecule |
| Therapeutic area | Pain management |
| Phase | Phase 3 |
Mechanism of action
The activation of TRPV1 receptors by capsaicin leads to the release of neurotransmitters that inhibit pain signals to the brain. NGX-4010 is designed to provide long-lasting pain relief for conditions such as postherpetic neuralgia.
Approved indications
- Postherpetic neuralgia
Common side effects
- Skin irritation
Key clinical trials
- A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment (PHASE4)
- A Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain
- Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (PHASE3)
- Study of NGX-4010 With the Use of Open Label Lidocaine (2.5%)/Prilocaine (2.5%) Cream for the Treatment of Postherpetic Neuralgia (PHN) (PHASE2)
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:
- NGX-4010, 8% capsaicin patch CI brief — competitive landscape report
- NGX-4010, 8% capsaicin patch updates RSS · CI watch RSS
- NeurogesX portfolio CI
Frequently asked questions about NGX-4010, 8% capsaicin patch
What is NGX-4010, 8% capsaicin patch?
How does NGX-4010, 8% capsaicin patch work?
What is NGX-4010, 8% capsaicin patch used for?
Who makes NGX-4010, 8% capsaicin patch?
Is NGX-4010, 8% capsaicin patch also known as anything else?
What drug class is NGX-4010, 8% capsaicin patch in?
What development phase is NGX-4010, 8% capsaicin patch in?
What are the side effects of NGX-4010, 8% capsaicin patch?
What does NGX-4010, 8% capsaicin patch target?
Related
- Drug class: All Topical analgesic drugs
- Target: All drugs targeting TRPV1
- Manufacturer: NeurogesX — full pipeline
- Therapeutic area: All drugs in Pain management
- Indication: Drugs for Postherpetic neuralgia
- Also known as: the brandname of NGX-4010, 8% capsaicin patch is Qutenza., The brandname of NGX-4010, 8% capsaicin patch is Qutenza.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing