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Grammidin neo
Grammidin neo is a Small molecule drug developed by Valenta Pharm JSC. It is currently in Phase 1 development. Also known as: gramicidin s, cetylpyridinium chloride.
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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 | Grammidin neo |
|---|---|
| Also known as | gramicidin s, cetylpyridinium chloride |
| Sponsor | Valenta Pharm JSC |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Safety, Tolerability, and Pharmacokinetic Profile of Grammidin, a Metered Dose Topical Spray in Healthy Volunteers (PHASE1)
- Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, a Metered Dose Topical Spray in Healthy Volunteers (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:
- Grammidin neo CI brief — competitive landscape report
- Grammidin neo updates RSS · CI watch RSS
- Valenta Pharm JSC portfolio CI
Frequently asked questions about Grammidin neo
What is Grammidin neo?
Who makes Grammidin neo?
Is Grammidin neo also known as anything else?
What development phase is Grammidin neo in?
Related
- Manufacturer: Valenta Pharm JSC — full pipeline
- Also known as: gramicidin s, cetylpyridinium chloride
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing