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Capsaicin 1 Hour
Capsaicin 1 Hour is a Small molecule drug developed by Hjalte Holm Andersen. It is currently in Phase 1 development. Also known as: Qutenza.
Capsaicin 8% Patch is an intervention being studied for various conditions, including dysphagia, spinal cord injuries, neuropathic pain, and peripheral neuropathy, as part of clinical trials. The mechanism of action of capsaicin is associated with TRPV1 agonism, according to ChEMBL.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Capsaicin 1 Hour |
|---|---|
| Also known as | Qutenza |
| Sponsor | Hjalte Holm Andersen |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia. (PHASE3)
- To Check Dermatological Safety of Test Products by 24 Hours Patch Testing (NA)
- The Prevalence of Local Immunoglobulin E (IgE) Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population (PHASE3)
- Functional Magnetic Resonance Imaging of ATP Cough in Chronic Cough Patients (NA)
- Thermosensitivity of a Topical Palmitated Formulation of Capsaicin (EARLY_PHASE1)
- Pain, Sleep and Gut Microbiota (NA)
- Capsaicin 8% Patch for Spinal Cord Injury Neuropathic Pain (NA)
- FS-67 in the Treatment of Pediatric Patients With Ankle Sprain (PHASE4)
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:
- Capsaicin 1 Hour CI brief — competitive landscape report
- Capsaicin 1 Hour updates RSS · CI watch RSS
- Hjalte Holm Andersen portfolio CI
Frequently asked questions about Capsaicin 1 Hour
What is Capsaicin 1 Hour?
Who makes Capsaicin 1 Hour?
Is Capsaicin 1 Hour also known as anything else?
What development phase is Capsaicin 1 Hour in?
Related
- Manufacturer: Hjalte Holm Andersen — full pipeline
- Also known as: Qutenza
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing