Product Description
Fluconazole is used to treat fungal infections, including yeast infections of the vagina, mouth, throat, esophagus (tube leading from the mouth to the stomach), abdomen (area between the chest and waist), lungs, blood, and other organs. Fluconazole is also used to treat meningitis (infection of the membranes covering the brain and spine) caused by fungus. Fluconazole is also used to prevent yeast infections in patients who are likely to become infected because they are being treated with chemotherapy or radiation therapy before a bone marrow transplant (replacement of unhealthy spongy tissue inside the bones with healthy tissue). Fluconazole is in a class of antifungals called triazoles. It works by slowing the growth of fungi that cause infection. (Sourced from: https://medlineplus.gov/druginfo/meds/a690002.html)
Mechanisms of Action: Cytochrome P450 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intramuscular, Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Sanofi
Company Location: Europe
Company Founding Year: 1973
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, China, New Zealand, United Kingdom, United States
Active Clinical Trial Count: 13
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Sanofi presented P3 Influenza, Human results on 2025-10-19 for Fluconazole
Highest Development Phases
Phase 3: COVID-19|Influenza, Human
Phase 2: Hypercalciuria
Phase 1: Arthritis, Rheumatoid|Healthy Volunteers|Mouth Cancer|Oncology Unspecified|Pain Unspecified|Respiratory Syncytial Virus Infections|Stroke
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06847464 |
EDP 323-005 | P1 |
Completed |
Respiratory Syncytial Virus Infections |
2025-05-24 |
12% |
2025-07-02 |
Primary Completion Date|Primary Endpoints|Treatments|Trial Status |
NCT05661591 |
SHR2554-I-110 | P1 |
Completed |
Healthy Volunteers|Oncology Unspecified |
2023-03-31 |
23% |
2023-04-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06744205 |
FBP00021 | P2 |
Active, not recruiting |
Influenza, Human |
2026-04-16 |
2025-08-27 |
||
2020-003011-97 |
The FLUCOLITH study | P2 |
Active, not recruiting |
Hypercalciuria |
2024-05-14 |
2022-03-13 |
Treatments |
|
NCT06291857 |
CIC-E-301 | P3 |
Active, not recruiting |
Influenza, Human|COVID-19 |
2026-07-26 |
47% |
2025-07-19 |
|
NCT07395024 |
3082-CL-0102 | P1 |
Recruiting |
Mouth Cancer |
2026-07-31 |
88% |
2026-03-07 |
Primary Endpoints|Start Date |
ACTRN12618000076279p |
VPCOVID | P1 |
Not yet recruiting |
Stroke |
2020-04-30 |
|||
2016-004753-33 |
2016-004753-33 | P3 |
Active, not recruiting |
Influenza, Human |
2018-09-21 |
2025-06-29 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT07300085 |
CD388.SQ.1.08 | P1 |
Recruiting |
Influenza, Human |
2026-05-01 |
50% |
2025-12-24 |
Primary Endpoints|Treatments |
NCT06173596 |
D7420C00003 | P1 |
Completed |
Healthy Volunteers |
2024-04-30 |
12% |
2024-06-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
CTR20223340 |
CTR20223340 | P1 |
Completed |
Oncology Unspecified|Healthy Volunteers |
2023-03-31 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20244615 |
CTR20244615 | P1 |
Recruiting |
Arthritis, Rheumatoid |
None |
2025-04-29 |
Patient Enrollment|Treatments |
|
CTR20255270 |
CTR20255270 | P1 |
Active, not recruiting |
Pain Unspecified|Healthy Volunteers |
None |
2026-02-15 |
Patient Enrollment|Start Date|Treatments|Trial Status |