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Inersan
Inersan is a Small molecule drug developed by CD Pharma India Pvt. Ltd.. It is currently in Phase 3 development. Also known as: Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2.
Inersan, a probiotic lozenge, has been studied as a treatment for chronic periodontitis, specifically mild and moderate cases. The efficacy of Inersan as an adjunct to non-surgical periodontal therapy in chronic periodontitis patients was evaluated in a randomized double-blind trial.
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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).
| 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 | Inersan |
|---|---|
| Also known as | Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2 |
| Sponsor | CD Pharma India Pvt. Ltd. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Effect of Probiotic Lozenge on Gingivitis and Periodontitis (PHASE3)
- Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients. (PHASE3)
- Efficacy of INERSAN in Patients With Chronic Periodontitis as Adjunctive to Full Mouth Disinfection (NA)
- Effect of Probiotic Inersan and Doxycycline in Chronic Periodontitis (PHASE3)
- Efficacy of a Probiotic Lozenge (Inersan) in Patients With Chronic Periodontitis (PHASE3)
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:
- Inersan CI brief — competitive landscape report
- Inersan updates RSS · CI watch RSS
- CD Pharma India Pvt. Ltd. portfolio CI
Frequently asked questions about Inersan
What is Inersan?
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Related
- Manufacturer: CD Pharma India Pvt. Ltd. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Each lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing