Folvite

(Folic Acid)

ApprovedSmall molecule

Folic acid is a B vitamin used to prevent and treat deficiencies that can cause anemia and birth defects. It's commonly taken as a supplement by pregnant women and people with certain medical conditions.[2] Folvite is currently approved and in use across 69 indications[4].[1]

Folvite is one of 1463 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

108

Total Trials

Active Trials

1,462

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Gingival OvergrowthActive, not recruiting

Systemic Lupus ErythematosusApproved

DyspepsiaActive, not recruiting

Breast DiseaseActive, not recruiting

AlbuminuriaActive, not recruiting

Sudden Sensorineural Hearing LossApproved

Gestational DiabetesActive, not recruiting

Mood DisorderActive, not recruiting

Lung CancerActive, not recruiting

Coronary Artery DiseasePhase 2

Active, not recruiting

Gingival OvergrowthPhase 3

Active, not recruiting

Systemic Lupus ErythematosusApproved

Approved

DyspepsiaApproved

Active, not recruiting

Breast DiseaseApproved

Active, not recruiting

AlbuminuriaPreclinical

Active, not recruiting

Sudden Sensorineural Hearing LossApproved

Approved

Gestational DiabetesApproved

Active, not recruiting

Mood DisorderPreclinical

Active, not recruiting

Lung CancerPreclinical

Active, not recruiting

Showing 10 of 69 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Folvite

Eli Lilly

Approved

2 2

MS Contin

Merck & Co.

Preclinical

2 3

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 4

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 5

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

3 6

Fentanyl Citrate

IINSYS Therapeutics Inc

Preclinical

2 7

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

1 8

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

1 9

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

1 10

Bisphosphonate

Amgen

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Not yet recruiting

Colorectal Cancer

NCT05720559

Q4 2026

Post-ApprovalRecruiting

Gastric Intestinal Metaplasia

NCT06610266

Post-ApprovalActive, not recruiting

Osteoarthritis

NCT04579848

Phase 3Active, not recruiting

Chronic Kidney Disease

NCT05284656

Q3 2027

Phase 1Not yet recruiting

Acute Kidney Injury

NCT07013136

Q1 2028

Post-ApprovalNot yet recruiting

Breast Disease

NCT06943482

Clinical

Trials by Indication[1]

Rheumatoid Arthritis18 trials

Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis

Completed·PPeking University People's Hospital·Phase 2·NCT02467504·47 enrolled

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)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02293902·243 enrolled

Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

Completed· Sanofi logo

Sanofi·Phase 2/3·NCT01061736·1,675 enrolled

Show 15 more trials

Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis

Completed· GSK logo

GSK·Phase 1/2·NCT03028467·15 enrolled

Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)

Completed· Roche logo

Roche·Phase 2·NCT02093026·465 enrolled

Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate

Terminated· Takeda logo

Takeda·Phase 2·NCT02393378·7 enrolled

A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

Completed· Roche logo

Roche·Phase 1·NCT00965653·29 enrolled

A Study in Participants With Moderate to Severe Rheumatoid Arthritis

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01711359·588 enrolled

Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFα Antagonist Failed in Rheumatoid Arthritis

Withdrawn·BBird Rock Bio, Inc.·Phase 2·NCT02795299

A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA)

Completed·CChelsea Therapeutics·Phase 2·NCT01116141·250 enrolled

Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Completed·BBiocad·Phase 3·NCT02762838·426 enrolled

Study of Different Doses of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT01583959·100 enrolled

Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis

Completed· GSK logo

GSK·Phase 2·NCT02504671·222 enrolled

Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis

Completed· Sanofi logo

Sanofi·Phase 1·NCT01850680·61 enrolled

Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

Completed·JJawaharlal Institute of Postgraduate Medical Education & Research·Phase 4·NCT02644499·186 enrolled

Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis

Completed· GSK logo

GSK·Phase 2·NCT02799472·39 enrolled

Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)

Completed· Roche logo

Roche·Phase 2·NCT02833350·578 enrolled

SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Completed·44SC AG·Phase 2·NCT01010581·266 enrolled

Methotrexate3 trials

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

Completed· Roche logo

Roche·Phase 1·NCT02699710·50 enrolled

Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

Terminated·JJawaharlal Institute of Postgraduate Medical Education & Research·Phase 3·NCT02930343·136 enrolled

Effect of Methotrexate Carried by a Lipid Nanoemulsion on Left Ventricular Remodeling After STEMI

Terminated·UUniversity of Sao Paulo·Phase 2/3·NCT03516903·35 enrolled

Colorectal Cancer3 trials

Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection

Not yet recruiting·LLiaoning Cancer Hospital & Institute·Phase 2·NCT05720559·100 enrolled

Panitumumab After Resection of Liver Metastases From Colorectal Cancer in KRAS Wild-type Patients

Unknown status·PPD Dr. med. Volker Heinemann·Phase 2·NCT01384994·111 enrolled

Study of Folic Acid, Calcium and Vitamin D in Preventing Colorectal Polyps and Colorectal Cancer

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 2/3·NCT02066688·2,400 enrolled

Preoperative2 trials

Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries

Completed·—·Phase 3·NCT05570292·40 enrolled

Management of Preoperative Anaemia in Surgical Oncology

Unknown status·AAzienda Ospedaliera Universitaria Integrata Verona·Phase 4·NCT05505006·500 enrolled

Women2 trials

Bioavailability Study of Folic Acid in Healthy Women

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT00709267·12 enrolled

Dosage Effects of Folic Acid on Blood Folates of Honduran Women

Completed·CCenters for Disease Control and Prevention·N/A·NCT00207532·100 enrolled

69 more indications

Cardiac Surgical Patients2 trials

Patient Blood Management In CARdiac sUrgical patientS

Completed·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT04744181·479 enrolled

Preoperative Vitamin B12 and Folic Acid on POCD in Elderly Non-cardiac Surgical Patients

Terminated·XXijing Hospital·N/A·NCT03485404·40 enrolled

Children2 trials

Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children

Completed·QQueen Sirikit National Institute of Child Health·Phase 4·NCT01766310·50 enrolled

Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children

Unknown status·—·Phase 4·NCT03040219·100 enrolled

Prevention2 trials

Chemoprevention With Folic Acid

Completed·UUS Department of Veterans Affairs·Phase 2·NCT00018551

Oral Cleft Prevention Trial in Brazil

Completed·NNICHD Global Network for Women's and Children's Health·Phase 3·NCT00098319·2,200 enrolled

Trial2 trials

Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel

Completed·GGaleno Desenvolvimento de Pesquisas Clínicas·Phase 3·NCT03359057·36 enrolled

The Norwegian Vitamin Trial (NORVIT)

Completed·UUniversity of Tromso·N/A·NCT00266487·3,750 enrolled

Miscarriage2 trials

Hydroxychloroquine and Unexplained Recurrent Miscarriage

Completed·—·N/A·NCT04228263·156 enrolled

Low Molecular Weight Heparin in Recurrent Miscarriage With Negative Antiphospholipid Antibodies

Completed·OOmar Mamdouh Shaaban·Phase 4·NCT01608347·228 enrolled

Preeclampsia2 trials

Hydroxychloroquine in Prevention of Preeclampsia

Completed·—·N/A·NCT04755322·50 enrolled

High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention

Completed·OOttawa Hospital Research Institute·Phase 3·NCT01355159·2,464 enrolled

Non-Small Cell Lung Cancer2 trials

A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT01165021·19 enrolled

Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastases From Non-small Cell Lung Cancer

Completed·TThe First Hospital of Jilin University·Phase 1·NCT03101579·13 enrolled

Breast Cancer2 trials

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)

Withdrawn·EEndocyte·Phase 2·NCT01953536

ROLE OF FOLIC ACID IN THE MANAGEMENT OF ADJUVANT ENDOCRINE THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS

Not yet recruiting·FFuture University in Egypt·Phase 3·NCT06774885·120 enrolled

Acute Kidney Injury2 trials

Folate Treatment to Reduce Death Risk in the Year After Infection-Related Acute Kidney Injury

Not yet recruiting·TThe University of Hong Kong·Phase 1·NCT07377071·382 enrolled

Feasibility Test of Folic Acid on Acute Kidney Injury

Not yet recruiting·TThe University of Hong Kong·Phase 1·NCT07013136·90 enrolled

Mood Disorder1 trial

Prevention of Mood Disorders by Folic Acid Supplementation

Completed·UUniversity of Oxford·N/A·NCT00459264·112 enrolled

Immunology1 trial

TB Nutrition, Immunology and Epidemiology

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00170404·887 enrolled

Hypophosphatasia1 trial

Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 4·NCT06015750

Hypertension1 trial

H-Type Hypertension Precision Medicine Trial

Unknown status·SShenzhen Ausa Pharmed Co.,Ltd·Phase 4·NCT03472508·3,600 enrolled

Adalimumab1 trial

ADalimumab in Persistent Early Oligoarthrits Study (ADEOS)

Completed·UUniversity of Leeds·Phase 2·NCT04154852·22 enrolled

Atherosclerosis1 trial

BVAIT: B-Vitamin Atherosclerosis Intervention Trial

Completed·NNational Institute on Aging (NIA)·Phase 2/3·NCT00114400·506 enrolled

Inflammatory Bowel Disease1 trial

Folic Acid in Pediatric Inflammatory Bowel Disease

Unknown status·LLe Bonheur Children's Hospital·Phase 4·NCT03860012·100 enrolled

Age1 trial

Folic Acid Dosage and Malformations Reduction

Unknown status·AAzienda Ospedaliera Universitaria Integrata Verona·Phase 3·NCT01244347·5,000 enrolled

Albuminuria1 trial

The Effect of Folic Acid Administration in the Progression of Microalbuminuria

Completed·HHospital Universitario Dr. Jose E. Gonzalez·N/A·NCT00737126·40 enrolled

PET/CT Imaging1 trial

PET/CT Imaging Companion Study To ACTG A5314

Completed·MMassachusetts General Hospital··NCT02312219·35 enrolled

Postpartum Hemorrhage1 trial

Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

Completed·HHospital Universitario Dr. Jose E. Gonzalez·Phase 4·NCT01733329·123 enrolled

Metabolism1 trial

Relationship Between Folic Acid and Warfarin Metabolism and Effect

Unknown status·HHadassah Medical Organization·N/A·NCT00162409·400 enrolled

End-Stage Renal Disease1 trial

Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis

Completed·GGeorgetown University·N/A·NCT00004495·84 enrolled

Male Infertility1 trial

Impact of Folates in the Care of the Male Infertility

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT01407432·162 enrolled

Pregnancy1 trial

Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss

Completed·—·Phase 1·NCT03766594·90 enrolled

Urothelial Carcinoma1 trial

Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy

Unknown status·—·Phase 3·NCT03193788·74 enrolled

Treatment1 trial

Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients

Unknown status·UUniversitair Ziekenhuis Brussel·Phase 3·NCT03767569·134 enrolled

Kidney1 trial

Trial of Folic Acid Effect on Hcy and cIMT After Kidney Tx

Terminated·SShahid Beheshti University of Medical Sciences·Phase 4·NCT00570856·60 enrolled

Liver Metastases1 trial

Quintuple Method for Treatment of Multiple Refractory Colorectal Liver Metastases

Unknown status·LLiaoning Cancer Hospital & Institute·Phase 2·NCT05774964·100 enrolled

Primary Peritoneal Cancer1 trial

Carboplatin/Pralatrexate in Recurrent Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer

Completed·MMassachusetts General Hospital·Phase 1/2·NCT01188876·50 enrolled

NSCLC1 trial

Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00806819·718 enrolled

Randomized1 trial

Optimal MTX Dose With Folic Acid Randomized Case-control Trial

Unknown status·SSun Yat-sen University·Phase 4·NCT04066803·160 enrolled

Nephropathy1 trial

Folic Acid for Prevention of Contrast Induced Nephropathy

Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University·Phase 4·NCT02444013·400 enrolled

Gingival Overgrowth1 trial

Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth

Completed·—·Phase 3·NCT00781196·120 enrolled

Esophagitis1 trial

Folic Acid Interferes With Radiation Esophagitis

Unknown status·GGuizhou Medical University·N/A·NCT05296369·90 enrolled

Renal Cell Carcinoma1 trial

Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy

Recruiting·NNiels Fristrup·Phase 2·NCT03581773·100 enrolled

Active, not recruiting·—·Phase 4·NCT04579848·163 enrolled

Calcific Aortic Valve Disease1 trial

Folic Acid Supplementation in Calcific Aortic Valve Disease

Not yet recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 2·NCT05861648·100 enrolled

Parkinson's Disease1 trial

Effect of Folic Acid in Levodopa Treated Parkinson's Disease Patients

Unknown status·—·Phase 2·NCT05959044·60 enrolled

TED1 trial

A Study of Serum Folate Levels in Patients Treated With Olaparib

Completed·RRush University Medical Center·Phase 4·NCT04024254·10 enrolled

Breast Disease1 trial

Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease

Not yet recruiting·NNational University Hospital, Singapore·Phase 4·NCT06943482·40 enrolled

Immunotherapy1 trial

Perioperative Immunotherapy vs. Chemo-immunotherapy in Patients With Advanced GC and AEG

Unknown status·UUniversity Hospital, Essen·Phase 2·NCT04062656·21 enrolled

Drug Abuse1 trial

Effect of Folic Acid on the Presentation of Nuclear Abnormalities in People With a History Drug Abuse

Unknown status·CCentro Universitario de Tonalá·N/A·NCT05712044·45 enrolled

Hemodialysis1 trial

Effect of Zinc Supplementation on Hyperhomocysteinemia Compared to Folic Acid in CKD Patient on Hemodialysis

Recruiting·—·N/A·NCT06847139·90 enrolled

Oral ulcer1 trial

Therapeutic Effect of Folic Acid in Healing of Oral Ulcers

Unknown status·—·Phase 1·NCT04989049·75 enrolled

Chronic Kidney Disease1 trial

Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease

Active, not recruiting·—·Phase 3·NCT05284656·80 enrolled

Anemia1 trial

Treatment and Prevention of Anemia With Ferrous Sulfate Plus Folic Acid in Children in Goiania - Goias, Brazil

Completed·UUniversidade Federal de Goias·N/A·NCT00701246·196 enrolled

Misoprostol1 trial

Same-day Dilapan-S With Adjunctive Misoprostol

Terminated·UUniversity of Pittsburgh·N/A·NCT01818414·29 enrolled

Coronary Artery Disease1 trial

Effect of Folic Acid Treatment in Coronary Artery Disease

Unknown status·UUniversity of Oxford·Phase 2·NCT00300352·60 enrolled

Metastatic Cancer1 trial

ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT00034463

Dyspepsia1 trial

The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia

Unknown status·—·Phase 4·NCT01608750·200 enrolled

Randomised Controlled Trial1 trial

Folate Augmentation of Treatment - Evaluation for Depression: a Randomised Controlled Trial

Completed·—·Phase 4·NCT00514410·730 enrolled

Ovarian Reserve1 trial

of Myo-inositol, Melatonin and Co-enzyme q10 on Ovarian Reserve

Not yet recruiting·—·Phase 3·NCT06405204·200 enrolled

Efficacy and Safety1 trial

Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA

Completed·CCinnagen·Phase 3·NCT03172325·136 enrolled

Adolescent1 trial

Efficacy Study of Folic Acid Supplementation in Adolescent Epileptics

Unknown status·MMaharashtra University of Health Sciences·Phase 3·NCT02318446·36 enrolled

Inflammation1 trial

5-methyltetrahydrofolate Survival and Inflammation in ESRD Patients

Completed·IIRCCS Azienda Ospedaliero-Universitaria di Bologna·N/A·NCT00626223·341 enrolled

Gastric Intestinal Metaplasia1 trial

Efficacy and Safety of Weifuchun Tablet in Reversing Gastric Intestinal Metaplasia

Recruiting·YYongquan Shi·Phase 4·NCT06610266·400 enrolled

Sexual Function1 trial

Effect of Omega 3 Fats on Sperm Quality and Sexual Function

Terminated·RReproductive Partners Medical Group·Phase 2·NCT00406874·6 enrolled

Stroke1 trial

China Stroke Secondary Prevention Trial

Withdrawn·XXijing Hospital·N/A·NCT01317849

Endometrial1 trial

Efficacy of Diclofenac on Pain During Endometrial Sampling

Unknown status·MMahidol University·N/A·NCT01762306·90 enrolled

Recovery1 trial

Folic Acid Intervention During Recovery

Unknown status·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University·N/A·NCT04135885·300 enrolled

Leptomeningeal Metastasis1 trial

Intrathecal Pemetrexed for Leptomeningeal Metastasis

Completed·TThe First Hospital of Jilin University·Phase 1/2·NCT05289908·34 enrolled

Schizophrenia1 trial

Evaluation of Mirtazapine and Folic Acid for Schizophrenia:

Completed·—·Phase 4·NCT01263080·333 enrolled

COVID-191 trial

Treatment for COVID-19 in High-Risk Adult Outpatients

Terminated·UUniversity of Washington·Phase 2/3·NCT04354428·289 enrolled

Polycystic Ovary Syndrome1 trial

The Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome

Unknown status·UUniversity of Khartoum·Phase 1/2·NCT03268733·90 enrolled

Diabetic Nephropathy1 trial

Nitric Oxide (NO) Activity and Diabetic Nephropathy

Completed·UUniversity of Erlangen-Nürnberg Medical School·Phase 2/3·NCT00136188·100 enrolled

Mucositis1 trial

Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies

Completed·AAcrotech Biopharma Inc.·Phase 2·NCT02106650·36 enrolled

Unspecified3 trials

Myoinositol Effect on Asprosin Levels

Completed·NNear East University, Turkey·N/A·NCT05943158·40 enrolled

Folic Acid Supplementation in Gambian Primigravidae

Completed·LLondon School of Hygiene and Tropical Medicine·Phase 3·NCT00120822·1,000 enrolled

Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification

Completed·CCenters for Disease Control and Prevention·N/A·NCT00207558·1,100 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

FOLVITE

NDA NDA005897

Jan 1, 1982

FOLIC ACID

NDA NDA006135

Jan 26, 2026

QUIOFIC

NDA NDA216395

Sources

References

[1]
ClinicalTrials.gov — 108 trial records for Folic Acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Folvite drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Folic Acid compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Folic Acid. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216395). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Eli Lilly

Folvite

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q3 2027

Q1 2028

Trials by Indication[1]

Rheumatoid Arthritis18 trials

Methotrexate3 trials

Colorectal Cancer3 trials

Preoperative2 trials

Women2 trials

Cardiac Surgical Patients2 trials

Children2 trials

Prevention2 trials

Trial2 trials

Miscarriage2 trials

Preeclampsia2 trials

Non-Small Cell Lung Cancer2 trials

Breast Cancer2 trials

Acute Kidney Injury2 trials

Mood Disorder1 trial

Immunology1 trial

Hypophosphatasia1 trial

Hypertension1 trial

Adalimumab1 trial

Atherosclerosis1 trial

Inflammatory Bowel Disease1 trial

Age1 trial

Albuminuria1 trial

PET/CT Imaging1 trial

Postpartum Hemorrhage1 trial

Metabolism1 trial

End-Stage Renal Disease1 trial

Male Infertility1 trial

Pregnancy1 trial

Urothelial Carcinoma1 trial

Treatment1 trial

Kidney1 trial

Liver Metastases1 trial

Primary Peritoneal Cancer1 trial

NSCLC1 trial

Randomized1 trial

Nephropathy1 trial

Gingival Overgrowth1 trial

Esophagitis1 trial

Renal Cell Carcinoma1 trial

Gestational Diabetes1 trial

Premalignant Lesion1 trial

Osteoarthritis1 trial

Calcific Aortic Valve Disease1 trial

Parkinson's Disease1 trial

TED1 trial

Breast Disease1 trial

Immunotherapy1 trial

Drug Abuse1 trial

Hemodialysis1 trial

Oral ulcer1 trial

Chronic Kidney Disease1 trial

Anemia1 trial

Misoprostol1 trial

Coronary Artery Disease1 trial

Metastatic Cancer1 trial

Dyspepsia1 trial

Randomised Controlled Trial1 trial

Ovarian Reserve1 trial

Efficacy and Safety1 trial

Adolescent1 trial

Inflammation1 trial

Gastric Intestinal Metaplasia1 trial

Sexual Function1 trial

Stroke1 trial

Endometrial1 trial

Recovery1 trial

Leptomeningeal Metastasis1 trial

Schizophrenia1 trial

COVID-191 trial

Polycystic Ovary Syndrome1 trial