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KX01 ointment 1%
KX01 ointment 1% is a Small molecule drug developed by PharmaEssentia. It is currently in Phase 3 development.
KX01 is a topical ointment formulation designed to deliver therapeutic benefit through skin penetration for localized treatment.
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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 | KX01 ointment 1% |
|---|---|
| Sponsor | PharmaEssentia |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
KX01 1% ointment is a topical pharmaceutical formulation in Phase 3 development by PharmaEssentia. Without publicly disclosed mechanism details, the specific molecular target and therapeutic action remain proprietary. The ointment formulation suggests dermatological or localized tissue application.
Approved indications
Common side effects
Key clinical trials
- KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis (PHASE1)
- A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp (PHASE3)
- Safety Evaluation of KX01 Ointment 1% in Japanese Healthy Male Subjects (PHASE1)
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:
- KX01 ointment 1% CI brief — competitive landscape report
- KX01 ointment 1% updates RSS · CI watch RSS
- PharmaEssentia portfolio CI
Frequently asked questions about KX01 ointment 1%
What is KX01 ointment 1%?
How does KX01 ointment 1% work?
Who makes KX01 ointment 1%?
What development phase is KX01 ointment 1% in?
Related
- Manufacturer: PharmaEssentia — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing