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Biomoduline (LENTINAN)
Biomoduline (generic name: LENTINAN) is a lentinan drug. It is currently in Phase 2 development.
Biomoduline works by stimulating the immune system to produce more interferon, a protein that helps fight off infections and diseases.
Biomoduline (LENTINAN) is a small molecule drug belonging to the lentinan class. It is a polysaccharide derived from the Lentinula edodes mushroom, originally developed by and currently owned by. Biomoduline is used to stimulate the immune system, but its exact target and approved indications are unknown. Its commercial status and key safety considerations are not well-documented.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | LENTINAN |
|---|---|
| Drug class | lentinan |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
Think of Biomoduline like a key that unlocks the immune system's natural defense mechanisms. When taken, it helps the body produce more interferon, which then helps to fight off invading pathogens and diseases. This can help the body recover from illness and infection more quickly.
Approved indications
Common side effects
Key clinical trials
- Dose Escalation Safety Study of MM-10-001 in Healthy Subjects (PHASE1)
- Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients (PHASE2)
- Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients (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:
- Biomoduline CI brief — competitive landscape report
- Biomoduline updates RSS · CI watch RSS
Frequently asked questions about Biomoduline
What is Biomoduline?
How does Biomoduline work?
What is the generic name of Biomoduline?
What drug class is Biomoduline in?
What development phase is Biomoduline in?
Related
- Drug class: All lentinan drugs
- Therapeutic area: All drugs in Immunology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing