QUIOFIC (folic acid)
Quiofic is a folate analog used to help adult and pediatric patients with megaloblastic anemias caused by a folic acid deficiency. It works by providing an external source of folate, which is necessary for the body to maintain healthy red blood cell production. This medication helps patients by restoring normal bone marrow function and addressing the underlying nutritional gap.
How QUIOFIC Works
This drug acts as a precursor to tetrahydrofolic acid, which serves as a vital cofactor in the synthesis of purines and thymidylates. By supporting these reactions, it enables proper DNA synthesis and allows the bone marrow to produce normal red blood cells instead of megaloblastic ones. This process is essential for maintaining healthy erythropoiesis and correcting anemias related to folate deficiency.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2026-01-26
- Routes
- ORAL
- Dosage Forms
- SOLUTION
QUIOFIC Approval History
What QUIOFIC Treats
2 indicationsQUIOFIC is approved for 2 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Megaloblastic Anemia
- Folic Acid Deficiency
QUIOFIC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to QUIOFIC
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
45 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03581773 DARENCA4 | FASTERCC | Ph 2 | recruiting | Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy |
| NCT06015750 RESTORE | D8400C00001 AA-HPP-407, 2022-502793-17 | Ph 4 | withdrawn | Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia |
| NCT06610266 | KY20242224-F-1 | Ph 4 | recruiting | Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia |
| NCT05284656 results posted | Interventional | Ph 3 | active not recruiting | Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease |
| NCT05289908 | PMLM | Ph 1, Ph 2 | completed | Intrathecal Pemetrexed for Leptomeningeal Metastasis |
| NCT06405204 | Co-enzyme q10 | Ph 3 | not yet recruiting | of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve |
| NCT05570292 | FMASU MS210/2022 | Ph 3 | completed | Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries |
| NCT05720559 | 20230201zzg | Ph 2 | not yet recruiting | Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection |
| NCT04354428 results posted | STUDY00009878 INV-017062 | Ph 2, Ph 3 | terminated | Treatment for COVID-19 in High-Risk Adult Outpatients |
| NCT02930343 results posted | JIP/IEC/2016/27/893 | Ph 3 | terminated | Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy |
| NCT03172325 results posted | ADA.CIN.AJ94 IRCT2015030321315N1 | Ph 3 | completed | Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA |
| NCT03516903 | CAAE 68743417.5.0000.0068 SCOC SDC: 4508/17/008 | Ph 2, Ph 3 | terminated | Effect of Methotrexate Carried by a Lipid Nanoemulsion on Left Ventricular Remodeling After STEMI |
| NCT02504671 results posted | 201755 2014-003453-34 | Ph 2 | completed | Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis |
| NCT02833350 results posted | GA29350 2016-000335-40 | Ph 2 | completed | Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) |
| NCT02699710 QCL117578 | GP29832 2015-002471-25, QCL117578 | Ph 1 | completed | Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects |
| NCT02106650 | SPI-FOL-14-201 | Ph 2 | completed | Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies |
| NCT04154852 ADEOS | RR08/8685 2008-004877-17, 10060 | Ph 2 | completed | ADalimumab in Persistent Early Oligoarthrits Study (ADEOS) |
| NCT02644499 | JIP/IEC/SC/2013/5/433 | Ph 4 | completed | Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis |
| NCT01165021 results posted | 13621 H3E-EW-JMIP | Ph 2 | completed | A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer |
| NCT01711359 RA-BEGIN results posted | 14062 I4V-MC-JADZ | Ph 3 | completed | A Study in Participants With Moderate to Severe Rheumatoid Arthritis |
| NCT02467504 results posted | hrIL-2 RA | Ph 2 | completed | Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis |
| NCT03028467 results posted | 201789 | Ph 1, Ph 2 | completed | Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis |
| NCT02762838 | BCD-055-3 | Ph 3 | completed | Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis |
| NCT03101579 | IPRLM | Ph 1 | completed | Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastases From Non-small Cell Lung Cancer |
| NCT02393378 TELLUS results posted | MT203-2004 U1111-1160-1791, 15/SC/0020 | Ph 2 | terminated | Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate |
| NCT03766594 | SURPL | Ph 1 | completed | Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss |
| NCT01733329 results posted | GI07-011 | Ph 4 | completed | Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage |
| NCT02795299 | BRB-008-003 | Ph 2 | withdrawn | Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFα Antagonist Failed in Rheumatoid Arthritis |
| NCT02293902 results posted | EFC14059 U1111-1155-7401 | Ph 3 | completed | A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI) |
| NCT01188876 results posted | 10-113 | Ph 1, Ph 2 | completed | Carboplatin/Pralatrexate in Recurrent Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer |
| NCT03359057 | GDN 028/12 | Ph 3 | completed | Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel |
| NCT01061736 RA-MOBILITY results posted | EFC11072 2009-016266-90 | Ph 2, Ph 3 | completed | Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients |
| NCT00806819 results posted | 1199.14 2008-002072-10 | Ph 3 | completed | Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC |
| NCT01608347 LMWH-APAN | HAPAN | Ph 4 | completed | Low Molecular Weight Heparin in Recurrent Miscarriage With Negative Antiphospholipid Antibodies |
| NCT00965653 | NP22623 2009-011349-18 | Ph 1 | completed | A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis |
| NCT01263080 RECOVERY2 | RECOVERY2 | Ph 4 | completed | Evaluation of Mirtazapine and Folic Acid for Schizophrenia: |
| NCT01407432 FOLFIV | P 100108 | Ph 3 | completed | Impact of Folates in the Care of the Male Infertility |
| NCT01766310 results posted | Folic-01 | Ph 4 | completed | Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children |
| NCT01953536 | 8109-004 2012-005170-65 | Ph 2 | withdrawn | Safety and Efficacy Study of Vintafolide and Vintafolide Plus Paclitaxel Compared to Paclitaxel Alone in Participants With Triple Negative Breast Cancer (TNBC) (MK-8109-004) |
| NCT01583959 FOLVARI | P-124 | Ph 4 | completed | Study of Different Doses of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis |
| NCT01850680 | TDU13402 U1111-1134-0048 | Ph 1 | completed | Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis |
| NCT01116141 MOTION | CH-4051-RA202 | Ph 2 | completed | A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA) |
| NCT00136188 | SFB 423 TP B5 | Ph 2, Ph 3 | completed | Nitric Oxide (NO) Activity and Diabetic Nephropathy |
| NCT01010581 COMPONENT | SC12267-5-2009 | Ph 2 | completed | SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis |
| NCT00781196 PIGO | PIGO | Ph 3 | completed | Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
QUIOFIC FDA Label Details
Indications & Usage
FDA Label (PDF)QUIOFIC is indicated for the treatment of Megaloblastic Anemia; Folic Acid Deficiency.
Track QUIOFIC with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment