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ICM ADX-2191 injection
ICM ADX-2191 injection is a Aldehyde modulator Small molecule drug developed by Aldeyra Therapeutics, Inc.. It is currently in Phase 3 development for Dry eye disease, Ocular surface disease.
ADX-2191 is a reactive aldehyde species that inhibits aldehyde dehydrogenase (ALDH) to modulate immune and inflammatory responses.
ICM ADX-2191 injection is being studied in a clinical trial for the treatment of Primary Vitreoretinal Lymphoma. The mechanism of action of ICM ADX-2191 injection is currently unknown.
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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 | ICM ADX-2191 injection |
|---|---|
| Sponsor | Aldeyra Therapeutics, Inc. |
| Drug class | Aldehyde modulator |
| Target | Aldehyde dehydrogenase (ALDH) / reactive aldehydes |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
ADX-2191 works by targeting reactive aldehydes and aldehyde-producing pathways that drive pathological immune activation and inflammation. By modulating aldehyde metabolism and reducing aldehyde-mediated immune dysregulation, the drug aims to restore immune homeostasis and reduce inflammatory disease activity. This mechanism is designed to address conditions driven by aberrant aldehyde-mediated immune activation.
Approved indications
- Dry eye disease
- Ocular surface disease
Common side effects
- Eye irritation
- Conjunctival hyperemia
- Ocular discomfort
Key clinical trials
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:
- ICM ADX-2191 injection CI brief — competitive landscape report
- ICM ADX-2191 injection updates RSS · CI watch RSS
- Aldeyra Therapeutics, Inc. portfolio CI
Frequently asked questions about ICM ADX-2191 injection
What is ICM ADX-2191 injection?
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What drug class is ICM ADX-2191 injection in?
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What does ICM ADX-2191 injection target?
Related
- Drug class: All Aldehyde modulator drugs
- Target: All drugs targeting Aldehyde dehydrogenase (ALDH) / reactive aldehydes
- Manufacturer: Aldeyra Therapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Dry eye disease
- Indication: Drugs for Ocular surface disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing