Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CD101 IV, CD101 for Injection
CD101 · 1 trial · 5 indications
Number of Subjects with Incidence of Treatment Emergent Adverse Events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities.
Number of subjects with mycological eradication and complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. |
| Group 3 | ACTIVE_COMPARATOR | Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. |
| Group 2 | EXPERIMENTAL | Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. |
| Name | Type | Description |
|---|---|---|
| CD101 | DRUG | Intravenous antifungal therapy |
| Caspofungin | DRUG | Intravenous antifungal therapy |
| Fluconazole | DRUG | oral antifungal therapy |
| intravenous placebo | DRUG | normal saline |
| oral placebo | DRUG | microcrystalline cellulose |
Inclusion Criteria: * mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken less than or equal to 96 hours before randomization (defined as: at least 1 blood culture positive for Candida or positive test for Candida from a sponsor approved rapid diagnostic test or posi...
CD101 is being developed for the treatment of candidemia and invasive candidiasis, which are serious fungal infections. It is an investigational small molecule antifungal from Cidara Therapeutics. The clinical program has studied it in adults with these infections, including a Phase 2 trial that compared it with caspofungin followed by oral step-down therapy.
CD101 is being developed by Cidara Therapeutics, Inc., which trades on the Nasdaq under the ticker CDTX. The company is the sponsor of the clinical program evaluating CD101 for candidemia and related invasive fungal infections.
CD101 is in Phase 2 clinical development. It has completed one Phase 2 trial in patients with candidemia and/or invasive candidiasis. It is an investigational agent and has not been approved by the FDA for any indication.
CD101 has been evaluated in the completed Phase 2 trial NCT02734862, titled CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension. The trial enrolled 207 adults across the United States, Belgium, Bulgaria, Canada, Greece, Hungary, Italy, Romania, Russia, and Spain.
Yes, CD101 IV is another name for CD101. Both refer to the same investigational antifungal developed by Cidara Therapeutics for candidemia and invasive candidiasis. The IV designation reflects the intravenous formulation studied in the Phase 2 clinical program.