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Bepanthen

RWTH Aachen University · Phase 3 active Small molecule Under review

Bepanthen is a Small molecule drug developed by RWTH Aachen University. It is currently in Phase 3 development for Arthropod bite wound, Contact dermatitis due to poison oak, Diaper rash.

Bepanthen is a product that contains panthenol, a provitamin of vitamin B5, which is used as a moisturizer and to aid in wound healing. It has been studied in various clinical trials for conditions such as dry eye disease, diabetic foot ulcers, and sensitive skin, among others.

Likelihood of approval
59.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameBepanthen
SponsorRWTH Aachen University
ModalitySmall molecule
Therapeutic areaImmunology
PhasePhase 3

Approved indications

Common side effects

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Bepanthen

What is Bepanthen?

Bepanthen is a Small molecule drug developed by RWTH Aachen University, indicated for Arthropod bite wound, Contact dermatitis due to poison oak, Diaper rash.

What is Bepanthen used for?

Bepanthen is indicated for Arthropod bite wound, Contact dermatitis due to poison oak, Diaper rash, Disorder of skin, Eczema.

Who makes Bepanthen?

Bepanthen is developed by RWTH Aachen University (see full RWTH Aachen University pipeline at /company/rwth-aachen-university).

What development phase is Bepanthen in?

Bepanthen is in Phase 3.

What are the side effects of Bepanthen?

Common side effects of Bepanthen include anaphylactic reactions, anaphylactoid reactions, rash, erythema, pruritis, headache.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing