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Oraqix® gel
Oraqix® gel is a Small molecule drug developed by Joanneum Research Forschungsgesellschaft mbH. It is currently in Phase 1 development.
Oraqix gel is a topical anesthetic gel that contains a combination of lidocaine and prilocaine. It is used to treat various conditions, including genitourinary syndrome of menopause, and is administered directly to the skin.
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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 | Oraqix® gel |
|---|---|
| Sponsor | Joanneum Research Forschungsgesellschaft mbH |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Comparative Study of Selective Dorsal Neurectomy, Pulsed Radiofrequency Neuromodulation, and Intragranular Hyaluronic Acid Injection for Premature Ejaculation (NA)
- Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit (PHASE4)
- An Exploratory Pilot Study in Healthy Volunteers to Assess the Parameters for the Design of Bioequivalence Studies on Moderately Lipophilic, Moderately to Highly Protein Bound Drugs Using Dermal Open Flow Microperfusion (dOFM) (NA)
- Pharmacokinetic Study of Nanoencapsulated Gel of Lidocaine, Prilocaine and Combination of Lidocaine and Prilocaine (PHASE1)
- EMLA Cream in Hysteroscopy Practice (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:
- Oraqix® gel CI brief — competitive landscape report
- Oraqix® gel updates RSS · CI watch RSS
- Joanneum Research Forschungsgesellschaft mbH portfolio CI
Frequently asked questions about Oraqix® gel
What is Oraqix® gel?
Who makes Oraqix® gel?
What development phase is Oraqix® gel in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing