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Trimodulin
Trimodulin is a Small molecule drug developed by Biotest. It is currently in Phase 3 development. Also known as: BT588.
Trimodulin is a treatment being studied for various respiratory conditions, including Covid-19, respiratory infection, pneumonia, community-acquired pneumonia, and acute respiratory distress syndrome. It is being investigated as an add-on therapy to standard care in a randomized, double-blind, placebo-controlled 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 | Trimodulin |
|---|---|
| Also known as | BT588 |
| Sponsor | Biotest |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP) (PHASE3)
- Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia (PHASE3)
- Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19 (PHASE2)
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:
- Trimodulin CI brief — competitive landscape report
- Trimodulin updates RSS · CI watch RSS
- Biotest portfolio CI
Frequently asked questions about Trimodulin
What is Trimodulin?
Who makes Trimodulin?
Is Trimodulin also known as anything else?
What development phase is Trimodulin in?
Related
- Manufacturer: Biotest — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: BT588
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing