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INM004
INM004 is a Biologic drug developed by Inmunova S.A.. It is currently in Phase 3 development. Also known as: Active, Equine immunoglobulin fragment F(ab')2 anti-Shiga toxin, active.
INM004 is an immunotherapeutic agent designed to modulate immune responses, likely through activation or enhancement of anti-tumor immunity.
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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). -
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 | 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 | INM004 |
|---|---|
| Also known as | Active, Equine immunoglobulin fragment F(ab')2 anti-Shiga toxin, active |
| Sponsor | Inmunova S.A. |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
While specific mechanistic details for INM004 are limited in public literature, as a Phase 3 candidate from Inmunova S.A., it is likely an immunomodulatory or checkpoint-related therapeutic. The exact molecular target and mechanism require access to clinical trial protocols or company disclosures.
Approved indications
Common side effects
Key clinical trials
- Efficacy of INM004 in Children With STEC-HUS (PHASE3)
- A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS (PHASE2)
- Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS (PHASE2, PHASE3)
- Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab')2 Fragment (INM004) 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:
- INM004 CI brief — competitive landscape report
- INM004 updates RSS · CI watch RSS
- Inmunova S.A. portfolio CI
Frequently asked questions about INM004
What is INM004?
How does INM004 work?
Who makes INM004?
Is INM004 also known as anything else?
What development phase is INM004 in?
Related
- Manufacturer: Inmunova S.A. — full pipeline
- Therapeutic area: All drugs in Immunology
- Also known as: Active, Equine immunoglobulin fragment F(ab')2 anti-Shiga toxin, active
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing