Product Description
Folic acid is an essential nutrient from the B complex group of vitamins. Folate, as a cofactor, is involved in numerous intracellular reactions, and this is reflected in the various derivatives that have been isolated from biological sources. Folic acid is involved in single carbon transfer reactions and serves as a source of single carbon units in different oxidative states. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/11451208/)
Mechanisms of Action: DHFR Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
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 | 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: Vitamin D Deficiency | Vitamin D Deficiency | Vitamin D Deficiency
Known Adverse Events: Diplopia | Dizziness | Headache | Erythema | Pruritus | Anaphylaxis | Angioedema | Urticaria | Edema
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Burkina Faso, China, Denmark, Netherlands
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: Anemia
Phase 2: Arthralgia|Mucositis|Renal Cell Carcinoma
Phase 1: Conduct Disorder|Oncology Solid Tumor Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2024-515413-18-00 | P2 |
Unknown Status |
Renal Cell Carcinoma |
2026-05-01 |
|
| 2024-513538-40-02 | P2 |
Unknown Status |
Arthralgia |
2025-12-31 |
|
| BAT-8006-001-CR | P1 |
Recruiting |
Oncology Solid Tumor Unspecified |
2024-12-01 |
34% |
| BAT-8006-001-CR | P1 |
Recruiting |
Oncology Solid Tumor Unspecified |
2024-12-01 |
34% |
| BAT-8006-001-CR | P1 |
Recruiting |
Oncology Solid Tumor Unspecified |
2024-12-01 |
34% |
| SAMIA | P3 |
Completed |
Anemia |
2023-10-31 |