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Corneregel
Corneregel is a Small molecule drug developed by Laboratorios Sophia S.A de C.V.. It is currently in Phase 1 development. Also known as: dexpanthenol.
Corneregel, also known as BAY81-2996, is a topical treatment that has been studied for its potential benefits in wound healing, skin recovery, flu, cold, and allergic disorders of the respiratory system. It is a form of dexpanthenol, a derivative of pantothenic acid, which is a B vitamin.
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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 | Corneregel |
|---|---|
| Also known as | dexpanthenol |
| Sponsor | Laboratorios Sophia S.A de C.V. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
- Ocular burning
- headache
- rhinitis
- earache
- eyelid bruise
- elevated liver enzymes
- dysgeusia
- non-infectious diarrhea
- Food Allergy
Key clinical trials
- Safety Assessment, Instrumental and Perceived Efficacy 21 Days of Use at Home - Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment. (Phase 4)
- Phase IIIb, A Prospective, Open Label, Randomized, Controlled, Parallel Group, Multicenter Clinical Trial of 3 Months Duration Comparing Topical Application of Royal Jelly and Panthenol (PEDYPHAR® Oin (Phase 3)
- A Single-Group Study to Evaluate the Effects of an Eyelash Serum on Improving Eyelash Growth (NA)
- Evaluation of a Fixed Combination of Dexpanthenol and Hyaluronic Acid Preservative-free Eye Drops on Corneal Epithelialization After Trans Epithelial PRK: a Prospective, Contralateral, Randomized, Dou (Phase 4)
- Phase III Trial Comparing Best Supportive Care to Aloe Vera Gel as a Prophylactic Agent for Radiation Induced Skin Toxicity (Phase 3)
- A Randomized, Double-Blind, Split-Face Clinical Study to Evaluate the Redness Relief Efficacy of Instant Flush Products in Subjects With Sensitive Skin (NA)
- A Randomized Phase II Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hif (Phase 2)
- A Prospective, Multicentric, Randomized, Non-inferiority, Controlled, Open-label Clinical Investigation to Evaluate the Efficacy and Safety of the Use of Myrialen® Gel vs.Recugel®, Two Eye Gel Product (NA)
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:
- Corneregel CI brief — competitive landscape report
- Corneregel updates RSS · CI watch RSS
- Laboratorios Sophia S.A de C.V. portfolio CI
Frequently asked questions about Corneregel
What is Corneregel?
Who makes Corneregel?
Is Corneregel also known as anything else?
What development phase is Corneregel in?
What are the side effects of Corneregel?
Related
- Manufacturer: Laboratorios Sophia S.A de C.V. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: dexpanthenol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing