Product Description
Mechanisms of Action: CYP3A4 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral, Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Canada | Cyprus | Czech | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Peru | Poland | Portugal | Romania | Russia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | United Arab Emirates | United Kingdom
Approved Indications: None
Known Adverse Events: None
Company: Astellas Pharma
Company Location: NEW YORK NY 10005
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 4: Invasive Fungal Infections|Lung Transplant
Phase 3: Candidiasis, Invasive|Candidemia|Acute Myeloid Leukemia|Invasive Fungal Infections|Aspergillosis|Respiratory Insufficiency|Invasive Pulmonary Aspergillosis|Severe Acute Respiratory Syndrome|Coronavirus Infections
Phase 2: Preleukemia|Pulmonary Aspergillosis|Neutropenia|Invasive Pulmonary Aspergillosis|Acute Myeloid Leukemia|Myelodysplastic Syndrome|Myeloproliferative Disorders|Aspergillosis
Phase 1: Healthy Volunteers|Kidney Diseases
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT07080359 |
Efficacy and Safety | N/A |
Not yet recruiting |
Zygomycosis|Aspergillosis|Mucormycosis |
2029-12-31 |
2025-07-24 |
Primary Endpoints |
|
ChiCTR2500095746 |
ChiCTR2500095746 | N/A |
Not yet recruiting |
Mucormycosis |
2027-12-31 |
|||
NCT06440915 |
YJK-001 | N/A |
Recruiting |
Aspergillosis|Zygomycosis|Mucormycosis |
2026-06-30 |
2024-12-14 |
Primary Endpoints |
|
ChiCTR2400086245 |
ChiCTR2400086245 | N/A |
Not yet recruiting |
Aspergillosis|Mucormycosis |
2026-06-30 |
2024-06-27 |
Treatments |
|
NCT07185503 |
Efficacy and Safety | N/A |
Recruiting |
Mucormycosis |
2026-06-01 |
2025-09-23 |
Primary Endpoints|Treatments |
|
NCT05426499 |
NCT05426499 | N/A |
Recruiting |
Oncology Unspecified |
2025-06-30 |
2025-06-03 |
Primary Completion Date|Primary Endpoints|Treatments|Trial Status |
|
NCT05630976 |
C3791001 | P4 |
Completed |
Invasive Fungal Infections |
2025-04-11 |
2025-07-11 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT04876716 |
IA-DUET | P3 |
Terminated |
Aspergillosis |
2024-05-01 |
2024-05-08 |
||
NCT04550936 |
PRISMA | N/A |
Completed |
Zygomycosis|Mucormycosis|Aspergillosis |
2023-12-23 |
2024-03-20 |
Primary Endpoints |
|
CTR20233021 |
CTR20233021 | N/A |
Completed |
Aspergillosis|Mucormycosis |
2023-11-07 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20233020 |
CTR20233020 | N/A |
Completed |
Aspergillosis|Mucormycosis |
2023-11-06 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Trial Status |
|
2019-002569-37 |
EFRAIM II | P3 |
Unknown status |
Respiratory Insufficiency |
2023-05-13 |
|||
2017-003435-11 |
2017-003435-11 | P2 |
Terminated |
Aspergillosis |
2022-02-14 |
34% |
2022-03-13 |
Treatments |
NCT04707703 |
Isavu-CAPA | P3 |
Terminated |
Invasive Pulmonary Aspergillosis|Coronavirus Infections|Severe Acute Respiratory Syndrome |
2021-10-25 |
20% |
2022-07-30 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2019-004240-30 |
PS-ISA-01 | P4 |
Active, not recruiting |
Lung Transplant |
2021-05-29 |
2022-03-13 |
Treatments |
|
NCT03019939 |
NCI-2017-00323 | P2 |
Completed |
Myelodysplastic Syndrome|Acute Myeloid Leukemia|Preleukemia|Neutropenia |
2020-08-10 |
2021-09-26 |
Patient Enrollment|Primary Endpoints|Treatments |
|
ACTRN12618001263280p |
ER2EP | N/A |
Not yet recruiting |
Musculoskeletal Pain|Acute Pain|Low Back Pain |
2020-02-03 |
|||
2016-003921-40 |
Isavuconazole for CPA | P2 |
Terminated |
Pulmonary Aspergillosis |
2018-05-02 |
2022-03-13 |
Treatments |
|
NCT03149055 |
NCT03149055 | P2 |
Completed |
Myeloproliferative Disorders |
2019-08-20 |
31% |
2021-11-18 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT03327727 |
VL2397-201 | P2 |
Terminated |
Invasive Pulmonary Aspergillosis |
2019-01-14 |
34% |
2019-03-21 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |
NCT00413218 |
9766-CL-0105 | P3 |
Completed |
Candidemia|Candidiasis, Invasive |
2015-03-03 |
2019-03-21 |
Treatments |
|
NCT02128321 |
9766-CL-0053 | P1 |
Completed |
Healthy Volunteers |
2014-02-01 |
2019-03-20 |
Treatments |
|
NCT02128893 |
9766-CL-0054 | P1 |
Completed |
Healthy Volunteers |
2014-02-01 |
2019-03-20 |
Treatments |
|
NCT00634049 |
VITAL | P3 |
Completed |
Aspergillosis|Invasive Fungal Infections |
2014-01-03 |
2019-03-22 |
Treatments |
|
NCT01555866 |
9766-CL-0018 | P1 |
Completed |
Kidney Diseases |
2013-04-01 |
2019-03-19 |
Treatments |