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Leukotriene B4
Leukotriene B4 is a Small molecule drug developed by LEO Pharma. It is currently in Phase 1 development.
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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 | Leukotriene B4 |
|---|---|
| Sponsor | LEO Pharma |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP) (PHASE3)
- Skin IaM: An Exploratory Clinical Trial to Evaluate Changes in Skin Appearance, Colour, and/or Texture Following the Induction of a Local Inflammatory Skin Response (NA)
- Inflammatory Responses in Normal Volunteers and Patients With Abnormal Immune Responses
- The Effect of Levocetirizine on Inflammatory Mediators in Dermatographism
- Comparison Study on Topical Anesthetic Agents (LMX4 and BLT) Prior to Fractional Skin Resurfacing (NA)
- The Effect of a Bifidobacterium and Polydextrose on Body Fat Mass (PHASE2)
- A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis (PHASE2)
- A Pilot Study of LTB4 in HIV-1 Infected Adults (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:
- Leukotriene B4 CI brief — competitive landscape report
- Leukotriene B4 updates RSS · CI watch RSS
- LEO Pharma portfolio CI
Frequently asked questions about Leukotriene B4
What is Leukotriene B4?
Who makes Leukotriene B4?
What development phase is Leukotriene B4 in?
Related
- Manufacturer: LEO Pharma — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing