lactic acid
Approved
Mar 22, 1971
Sodium lactate is primarily indicated as a source of bicarbonate for prevention or control of mild to moderate metabolic acidosis in patients with restricted oral intake whose oxidative processes are not seriously impaired. Sodium Lactate is most commonly associated with an E number of “E325” Sodium Lactate blends are commonly used in meat and poultry products to extend shelf life and increase food safety. They have a broad antimicrobial action and are effective at inhibiting most spoilage and pathogenic bacteria. In addition sodium lactate is used in cosmetics as a humectant, providing moisture. — NCATS
Clinical trial activity
117 trials · 64 clinical orgs · 9 marketing orgs
Earliest trial started Mar 1, 2002 (NCT00529490)
Timeline
1970s
- Mar 22, 1971
Baxter — Earliest FDA Approval
- Mar 22, 1971
Baxalta — NDA Secondary Org
- Mar 22, 1971
Baxter — NDA Secondary Org
- Mar 22, 1971
Baxter — NDA Organization
- Aug 13, 1975
ICU Medical Inc — Marketing Organization
- Aug 13, 1975
ICU Medical Inc — NDA Secondary Org
- Feb 8, 1978
B. Braun — NDA Secondary Org
1980s
2010s
- Jan 1, 2013
Earliest Phase 1 Sponsor(trial)
2020s
- May 22, 2020
Evofem Inc. — NDA Secondary Org
Indications
Studied for
- Acne Vulgaris · Phase 3
- Alcoholic Intoxication · Phase 4
- Behcet Syndrome · Phase 4
- Blood · Phase 2
- Body Fluids · Phase 4
- Brain Diseases · Phase 3
- Brain Injuries · Phase 2
- Brain Injuries, Traumatic · Phase 2
- Breast Neoplasms · Phase 3
- Burns · Phase 4
- Cardiac Output, Low · Phase 3
- Chlamydia · Phase 3
- Contraception · Phase 3
- Coronary Disease · Phase 4
- Craniocerebral Trauma · Phase 2/Phase 3
- Dermatitis, Atopic · Phase 4
- Diet, Ketogenic · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Emergencies · Phase 4
- Endothelial Cells · Phase 1/Phase 2
- Epilepsy · Phase 2
- Glucose Transporter Type 1 · Phase 2
- Gonorrhea · Phase 3
- Healthy Volunteers · Phase 3
- Heart Arrest · Phase 2
- Heart Failure · Phase 2
- Helicobacter pylori · Phase 4
- Hygiene · Phase 4
- Hyperemia · Early Phase 1
- Hyperlactatemia · Early Phase 1
- Hypertension · Phase 3
- Hypoglycemia · Phase 4
- Intracranial Hypertension · Phase 3
- Ischemic Preconditioning · Early Phase 1
- Keratosis, Actinic · Phase 2
- Kidney Failure, Chronic · Phase 4
- Liver Transplantation · Phase 4
- Low Back Pain · Phase 1
- Lumbar Vertebrae · Phase 1
- Major Depressive Disorder · Phase 2
- Membranes · Phase 4
- Metabolic Syndrome · Early Phase 1
- Microcirculation · Phase 1/Phase 2
- Neoplasms · Phase 3
- Pain · Phase 2
- Peritonitis · Phase 4
- Platelet-Rich Plasma · Phase 3
- Pneumonia · Phase 4
- Psoriasis · Phase 4
- Reperfusion Injury · Phase 2
- Sepsis · Phase 4
- Severe Dengue · Phase 3
- Sexual Dysfunction, Physiological · Phase 3
- Sexually Transmitted Diseases · Phase 3
- Shock, Hemorrhagic · Phase 3
- Shock, Septic · Phase 2/Phase 3
- Sodium Lactate · Phase 3
- Stroke · Phase 2
- Subarachnoid Hemorrhage · Phase 3
- Tonsillitis · Phase 1/Phase 2
- Vaginal Diseases · Phase 2
- Vaginosis, Bacterial · Phase 4
- Vascular System Injuries · Early Phase 1
Mechanism of action
- Unspecified targetOTHER
pH lowering agent
Antimicrobial activity
CNR2 other
Antimicrobial activity
Combination products
dextrose and electrolyte
with potassium chloride, sodium chloride, potassium phosphate, glucose monohydrate, magnesium
dianeal low calcium w/dextrose
with sodium chloride, calcium chloride, glucose monohydrate, magnesium
Also known as delflex-lm w/ dextrose, delflex w/ dextrose, delflex w/ dextrose low magnesium, delflex w/ dextrose low magnesium low calcium, dianeal 137 w/ dextrose, dianeal low calcium w/ dextrose, dianeal pd-1 w/ dextrose, dianeal pd-2 w/ dextrose, inpersol-lc/lm w/ dextrose
inpersol-zm w/ dextrose
ionosol b and dextrose
with potassium chloride, sodium phosphate, sodium chloride, potassium phosphate, glucose monohydrate, magnesium
ionosol mb and dextrose
with potassium chloride, sodium phosphate, potassium phosphate, glucose monohydrate, magnesium
lactated ringer's
lactated ringer's and dextrose
with potassium chloride, sodium chloride, calcium chloride, glucose monohydrate
Also known as dextrose and lactated ringer's, dextrose in half-strength lactated ringer's, dextrose in lactated ringer's, dextrose in modified lactated ringer's, potassium chloride in dextrose and lactated ringer's
phexxi
plasma-lyte m and dextrose
with potassium chloride, sodium acetate, sodium chloride, calcium chloride, glucose monohydrate, magnesium
plasma-lyte r
with potassium chloride, sodium acetate, sodium chloride, calcium chloride, magnesium
prismasol bk
with potassium chloride, sodium bicarbonate, sodium chloride, calcium chloride, glucose monohydrate, magnesium
Also known as prismasol b22gk, prismasol bgk
Approval history
- approvedMar 22, 1971
Chemistry & pharmacology
SMILES
CC(O)C(O)=O- Mol. weight
- 90.0779 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral, Topical
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
Yes
Sources
- WikipediaLactic acid ↗
- NCATS3B8D35Y7S4 ↗
- ChEMBLCHEMBL1357 ↗
- ChEMBLCHEMBL1200559 ↗
- WikipediaSodium lactate ↗
Also known as
- (±)-2-hydroxypropanoic acid
- (±)-2-hydroxypropanoic acid
- 2-hydroxypropanoic acid
- 2-hydroxypropanoic acid
- 2-hydroxypropionic acid
- 2-hydroxypropionic acid
- (2rs)-2-hydroxypropanoic acid
- acidum lacticum
- acidum lacticum
- compound solution of sodium lactate
- compound solution of sodium lactate
- dl- lactic acid
- dl- lactic acid
- dl-lactic acid
- dl-lactic acid
- dl-lactic acid
- dl-lactic acid
- dl-lactic acid
- dl-lactic acid
- dl-milchsäure
- dl-milchsäure
- e270
- e270
- e325
- e325
- lacolin
- lactate
- lactate
- lactate
- lactic acid
- lactic acid
- lactic acid
- lactic acid
- lactic acid
- lactic acid
- lactic acid
- lactic acid
- lactic acid, dl-
- lactic acid sodium salt
- lacticum acidum
- lacticum acidum
- l-lactic acid
- l-lactic acid
- milchsäure
- milchsäure
- milk acid
- milk acid
- monosodium lactate
- rac-lactic acid
- rac-lactic acid
- sodium lactate
- sodium lactate
- sodium lactate
- sodium lactate
- sodium lactate
- sodium lactate
- sodium lactate
- sodium lactate
- sod lact co
- sta363
- α-hydroxypropanoic acid
- α-hydroxypropanoic acid
- α-hydroxypropionic acid
- α-hydroxypropionic acid
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06825143 | Early Phase 1 (Phase 1) | Oct 1, 2026 | Western Colorado University |
| NCT06955130 | N/A | Jul 1, 2026 | Rutgers University |
| NCT06701760 | Phase 2 | Jan 5, 2026 | University of California, Los Angeles |
| NCT06665763 | N/A | Feb 1, 2025 | Aarhus University |
| NCT06626984 | Phase 1/Phase 2 (Phase 2) | Dec 1, 2024 | Medical Research Council, Queen's University, Belfast |
| NCT06634069 | Phase 2 | Oct 31, 2024 | University of Pilsen |
| NCT06668714 | N/A | Aug 22, 2024 | Aarhus University |
| NCT06379815 | N/A | May 1, 2024 | Natural Sciences and Engineering Research Council, Canada, Wilfrid Laurier University |
| NCT06265337 | N/A | Apr 11, 2024 | Aarhus University |
| NCT06110429 | Phase 3 | Jan 31, 2024 | University of Geneva |
| NCT06168175 | Phase 2 | Jan 31, 2024 | University of Lausanne |
| NCT06327581 | N/A | Dec 15, 2023 | Zagazig University |
| NCT06121323 | N/A | Nov 22, 2023 | Aarhus University |
| NCT06022263 | Phase 1 | Jul 25, 2023 | Antaros Medical AB, Cromsource, Stayble Therapeutics |
| NCT06978049 | N/A | Jan 31, 2023 | Saint Andrew Hospital Constanta |
| NCT05259007 | Phase 4 | Feb 22, 2022 | Apipark Beekeeping, Istanbul Medipol University |
| NCT05004610 | Phase 2 | Jan 1, 2022 | Erasmus University Rotterdam |
| NCT04858139 | Phase 2 | May 27, 2021 | University of Lausanne |
| NCT04887480 | N/A | May 14, 2021 | Sanford Health |
| NCT04710875 | N/A | Mar 10, 2021 | Aarhus University |
Organizations
Research & Development (64)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 52 | 52 | 3 | 2007 |
| Sanofi-Aventis | For profit | 12 | 0 | 1 | 2007 |
| Aarhus University | Academic/Hospital | 6 | 6 | 1 | 2020 |
| Innogene Kalbiotech Pte. Ltd | For profit | 6 | 5 | 3 | 2002 |
| Yuria-Pharm | For profit | 4 | 4 | 1 | 2016 |
| Evofem Inc. | For profit | 3 | 3 | 2 | 2017 |
| Padjadjaran University | Academic/Hospital | 3 | 1 | 2 | 2008 |
| Radboud University | Academic/Hospital | 3 | 3 | 2 | 2016 |
| Stayble Therapeutics | For profit | 3 | 3 | 2 | 2017 |
| University of Lausanne | Academic/Hospital | 3 | 3 | 2 | 2012 |
| University of Nice Sophia Antipolis | Academic/Hospital | 3 | 2 | 3 | 2011 |
| Institut d'Anesthesiologie des Alpes Maritimes | Academic/Hospital | 2 | 2 | 2 | 2009 |
| Mayo Clinic | Academic/Hospital | 2 | 1 | 2 | 2006 |
| Seoul National University | Academic/Hospital | 2 | 2 | 2 | 2009 |
| University of California, Los Angeles | Academic/Hospital | 2 | 2 | 1 | 2016 |
| Antaros Medical AB | For profit | 1 | 0 | 1 | 2023 |
| Apipark Beekeeping | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Assiut University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Bremer Pharmacovigilance Service GmbH | For profit | 1 | 0 | 1 | 2020 |
| Clinical Research Management, Inc. | For profit | 1 | 0 | 1 | 2017 |
Marketing (15)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Abbott | For profit | NDA2 | — |
| B. Braun | For profit | NDA2 | Feb 8, 1978 |
| Baxalta | For profit | NDA2 | Mar 22, 1971 |
| Baxalta | For profit | SYN | Oct 25, 2006 |
| Baxter | For profit | NDA2 | Mar 22, 1971 |
| Baxter | For profit | NDA | Mar 22, 1971 |
| Evofem Inc. | For profit | NDA2 | May 22, 2020 |
| Fresenius | For profit | SYN | Jun 13, 1994 |
| Fresenius | For profit | MKTG | Sep 3, 1980 |
| Fresenius | For profit | SYN | Jan 28, 2019 |
| Fresenius | For profit | NDA2 | Sep 3, 1980 |
| Hospira | For profit | NDA2 | Jul 25, 1980 |
| ICU Medical Inc | For profit | MKTG | Aug 13, 1975 |
| ICU Medical Inc | For profit | NDA2 | Aug 13, 1975 |
| Miles | For profit | NDA2 | — |