Overview
A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium-chelating ability. Citric acid is one of the active ingredients in Phexxi, a non-hormonal contraceptive agent that was approved by the FDA on May 2020. It is also used in combination with magnesium oxide to form magnesium citrate, an osmotic laxative.
Indication
No indication information available.
Associated Conditions
- Acidosis
- Catheter site calcification caused by appetite
- Catheter site calcification caused by struvite
- Gout
- Headache
- Heartburn
- Kidney Stones
- Metabolic Acidosis
Research Report
A Comprehensive Monograph on Citric Acid: From Core Metabolism to Clinical Application and Pharmaceutical Formulation
1.0 Executive Summary
Citric acid, a ubiquitous tricarboxylic acid identified by DrugBank ID DB04272, occupies a unique and indispensable position in both human physiology and modern medicine. It functions dually as a targeted Active Pharmaceutical Ingredient (API) for specific metabolic and renal conditions and as a versatile, multifunctional excipient critical to pharmaceutical formulation. Its fundamental role as a key intermediate in the citric acid (TCA) cycle underpins its biocompatibility and favorable safety profile. As an API, its therapeutic utility is primarily derived from two key mechanisms: systemic alkalinization and metal ion chelation. Following oral administration, citric acid is almost completely metabolized to bicarbonate, which acts as a systemic alkalinizing agent to correct metabolic acidosis and raise urinary pH, thereby preventing the formation of certain types of renal calculi. Its potent calcium-chelating properties are leveraged for anticoagulation in blood products and extracorporeal circuits.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/09/14 | Not Applicable | Completed | Aalborg University | ||
2023/03/03 | Early Phase 1 | Recruiting | Queen's Medical Center | ||
2021/12/08 | Phase 4 | Recruiting | |||
2021/01/08 | Not Applicable | UNKNOWN | Nada Yousef | ||
2019/10/02 | Phase 1 | Recruiting | |||
2019/06/26 | Not Applicable | Completed | |||
2018/12/07 | Phase 4 | Completed | |||
2017/06/26 | Phase 4 | Terminated | |||
2017/03/03 | Phase 3 | UNKNOWN | The First Affiliated Hospital of Henan University of Science and Technology | ||
2015/02/10 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Pharmaceutical Associates, Inc. | 0121-0595 | ORAL | 334 mg in 5 mL | 12/15/2022 | |
| Nabriva Therapeutics US, Inc. | 72000-030 | INTRAVENOUS | 166 mg in 270 mL | 10/13/2021 | |
| Terumo Corporation | 53877-001 | INTRAVENOUS | 2.99 g in 1000 mL | 12/7/2018 | |
| Terumo Corporation | 53877-001 | INTRAVENOUS | 2.99 g in 1000 mL | 12/7/2018 | |
| Cardinal Health 107, LLC | 55154-5777 | ORAL | 334 mg in 5 mL | 6/21/2019 | |
| Fenwal, Inc. | 0942-9394 | INTRAVENOUS | 188 mg in 63 mL | 11/1/2022 | |
| Fenwal, Inc. | 0942-0641 | INTRAVENOUS | 3.65 g in 500 mL | 2/11/2022 | |
| Fenwal, Inc. | 0942-6326 | INTRAVENOUS | 209 mg in 70 mL | 8/27/2014 | |
| AvPAK | 50268-182 | ORAL | 334 mg in 5 mL | 6/13/2023 | |
| Fenwal, Inc. | 0942-9201 | INTRAVENOUS | 105 mg in 35 mL | 11/1/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| POTCIT MIXTURE | SIN05148P | SOLUTION | 200 mg/5 ml | 10/16/1990 | |
| POTASSIUM CITRATE MIXTURE BP | SIN06732P | SOLUTION | 5% w/v | 12/19/1991 | |
| ALKA-SELTZER TABLET (Lemon Flavour) | SIN08632P | TABLET | 1223 mg | 4/4/1996 | |
| E-Z-GAS II GRANULES | SIN06442P | GRANULE | 1.54 g/4 g | 7/11/1991 | |
| PICOPREP Powder for Oral Solution | SIN14303P | POWDER, FOR SOLUTION | 12 g | 1/30/2013 | |
| Ural Effervescent Granules | SIN14374P | GRANULE, EFFERVESCENT | 0.72g | 6/26/2013 | |
| PICO-SWIFT POWDER FOR ORAL SOLUTION | SIN17163P | POWDER, FOR SOLUTION | 12000 mg | 1/16/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| LEMON FLAVOURED ENO FRUIT SALT | N/A | N/A | N/A | 8/8/1983 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MEDIX Dry Cough Medicine | 283737 | Medicine | A | 12/17/2016 | |
| Hydralyte Orange Electrolyte Powder (Tub) | 292256 | Medicine | A | 7/31/2017 | |
| Overnight Cleanse | 344734 | Medicine | A | 9/28/2020 | |
| Hydralyte Tropical Flavoured Effervescent Electrolyte Tablets | 370691 | Medicine | A | 7/7/2021 | |
| APOHEALTH Cystitis Relief oral powder sachet | 227717 | Medicine | A | 9/8/2014 | |
| Everyday Hydration Mixed Berry | 408802 | Medicine | A | 5/11/2023 | |
| Hydrate + Energy Raspberry Burst | 468609 | Medicine | A | 11/14/2024 | |
| Hydralyte Lemon Lime Effervescent Electrolyte Tablets | 217300 | Medicine | A | 11/14/2013 | |
| Chemists' Own Cystitis Relief effervescent granules sachet | 297741 | Medicine | A | 12/19/2017 | |
| Help at Hand for Irritating Dry Coughs | 295064 | Medicine | A | 10/13/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ORAL PURGATIVE | odan laboratories ltd | 02370271 | Powder For Solution - Oral | 12 G / PCK | 11/16/2011 |
| HEMOSATE ULTRA HS4125 | chief medical supplies ltd | 02413922 | Solution - Haemodialysis | 6.91 G / L | 3/30/2020 |
| HEMOSATE ULTRA HS1125 | chief medical supplies ltd | 02413892 | Solution - Haemodialysis | 6.91 G / L | 3/30/2020 |
| HEMOSATE ULTRA HS2150 | chief medical supplies ltd | 02413957 | Solution - Haemodialysis | 6.91 G / L | 3/4/2020 |
| HEMASATE ULTRA HS4125 | chief medical supplies ltd | 02422417 | Solution - Haemodialysis | 7.18 G / L | N/A |
| UBICOENZYME | 02236503 | Liquid - Oral | 8 D | 2/6/1998 | |
| HEMOSATE ULTRA HS3150 | chief medical supplies ltd | 02413965 | Solution - Haemodialysis | 6.91 G / L | N/A |
| CITRASATE C2150 | chief medical supplies ltd | 02366606 | Solution - Haemodialysis | 6.91 G / L | 2/21/2013 |
| ANTICOAGULANT SOLUTION CITRATE PHOSPHATE DEXTROSE (CPD) | maco pharma | 02444100 | Solution - 0-Unassigned | 3.27 G / L | 8/22/2016 |
| CITRACLEEN | laboratorios casen-fleet, s.l.u. | 02437880 | Powder For Solution - Oral | 10.97 G / 15.08 G | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.