Approval Probability
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CDI-988 · 2 trials · 2 indications
Disease is defined as diarrhea and/or vomiting (during the inpatient period), with laboratory-confirmed infection (with SMV specific primers on stool/emesis) or seroconversion
number of participants with treatment-emergent adverse events
number of participants with clinically significant laboratory abnormalities
number of participants with clinically significant changes from baseline in vital signs
number of participants with clinically significant changes from baseline in ECGs
| Arm | Type | Description |
|---|---|---|
| Snow Mountain Virus | OTHER | Challenge with Snow Mountain Virus |
| Stage 2: Drug CDI-988 | EXPERIMENTAL | - |
| Stage 2: Placebo | PLACEBO_COMPARATOR | - |
| SAD Cohort 1A | EXPERIMENTAL | first single-dose level |
| SAD Cohort 1B | EXPERIMENTAL | second single-dose level |
| SAD Cohort 1C | EXPERIMENTAL | third single-dose level; food-effect cohort |
| SAD Cohort 1D | EXPERIMENTAL | fourth single-dose level |
| MAD Cohort 2A | EXPERIMENTAL | first multiple-dose level |
| MAD Cohort 2B | EXPERIMENTAL | second multiple-dose level |
| MAD Cohort 2C | EXPERIMENTAL | third multiple-dose level |
| SAD Cohort 1E | EXPERIMENTAL | fifth dose level; food effect cohort |
| SAD Cohort 1F | EXPERIMENTAL | sixth dose level |
| MAD Cohort 2D | EXPERIMENTAL | 4th multiple dose level |
| MAD Cohort 2E | EXPERIMENTAL | 5th multiple dose level |
| MAD Cohort 2F | EXPERIMENTAL | 6th multiple dose level |
| Name | Type | Description |
|---|---|---|
| CDI-988 | DRUG | Antiviral to treat norovirus |
| Placebo | DRUG | Matching placebo |
| Snow Mountain Virus | OTHER | Challenge with Snow Mountain Virus |
Inclusion Criteria: * Healthy male or non-pregnant female * Aged 18 to 49 years * Good state of health * Known fucosyl transferase 2 (FUT2) secretor status Exclusion Criteria: * History of participation in any norovirus challenge or vaccine clinical trial * Receipt or planned receipt of any non-l...
CDI-988 is an investigational small molecule being developed by Cocrystal Pharma, Inc. for the prevention or treatment of norovirus infection. It is currently being studied in healthy volunteers and in a norovirus challenge study. The drug is in Phase 1 clinical development and has not been approved by the FDA.
CDI-988 targets the protease enzyme of norovirus. As a small molecule protease inhibitor, it is designed to interfere with viral replication. This mechanism is being evaluated in early-stage clinical trials to assess its safety and potential efficacy against norovirus.
CDI-988 is being developed by Cocrystal Pharma, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol COCP. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for norovirus.
CDI-988 is in Phase 1 clinical development. It has completed one Phase 1 safety study in healthy participants and is currently recruiting for another Phase 1 study involving a norovirus challenge. The drug is investigational and has not received FDA approval.
CDI-988 has been studied in two Phase 1 trials. NCT05977140 was a completed safety study in 116 healthy participants in Australia. NCT07198139 is an ongoing recruiting study in the United States evaluating efficacy, safety, and pharmacokinetics in healthy adults after challenge with Snow Mountain virus.
No, CDI-988 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The FDA has granted it Fast Track designation, which is intended to expedite development and review, but the drug remains in clinical development and has not been approved for any use.