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PF-06947386
PF-06947386 is a PDE4 inhibitor Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Systemic lupus erythematosus (SLE).
PF-06947386 is a selective inhibitor of phosphodiesterase 4 (PDE4) that reduces inflammatory signaling by increasing intracellular cAMP levels.
PF-06947386 is a selective inhibitor of phosphodiesterase 4 (PDE4) that reduces inflammatory signaling by increasing intracellular cAMP levels. Used for Systemic lupus erythematosus (SLE).
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | PF-06947386 |
|---|---|
| Sponsor | Pfizer |
| Drug class | PDE4 inhibitor |
| Target | PDE4 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting PDE4, the drug prevents the breakdown of cyclic adenosine monophosphate (cAMP), leading to elevated cAMP levels in immune and inflammatory cells. This suppresses the production of pro-inflammatory cytokines and chemokines, thereby reducing inflammation. The mechanism is particularly relevant for conditions driven by excessive innate immune activation.
Approved indications
- Systemic lupus erythematosus (SLE)
Common side effects
- Nausea
- Diarrhea
- Headache
- Vomiting
Key clinical trials
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:
- PF-06947386 CI brief — competitive landscape report
- PF-06947386 updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about PF-06947386
What is PF-06947386?
How does PF-06947386 work?
What is PF-06947386 used for?
Who makes PF-06947386?
What drug class is PF-06947386 in?
What development phase is PF-06947386 in?
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What does PF-06947386 target?
Related
- Drug class: All PDE4 inhibitor drugs
- Target: All drugs targeting PDE4
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Systemic lupus erythematosus (SLE)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing