> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/citric-acid-25b001b8-fd7a-438c-85e8-81f14a72a65a
> Record changed: 2026-10-13

# Citric acid

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1261)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1261)

First approval year

1982

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1261)

## Development status

**First approval year**

1982

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1261)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1261)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1261)

**Drug name**

Citric acid

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1261)

**Molecular weight**

192.12

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1261)

**Structure (SMILES)**

O=C(O)CC(O)(CC(=O)O)C(=O)O

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1261)

### Brand names (10)

- citric acid component of clenpiq
- Citric acid component of clenpiq
- citric acid component of phexxi
- Citric acid component of phexxi
- citric acid component of prepopik
- Citric acid component of prepopik
- citric acid component of renacidin
- Citric acid component of renacidin
- urologic g
- Urologic g

### Other names (84)

- 1 2 3 propanetricarboxylic acid 2 hydroxy
- 1,2,3-PROPANETRICARBOXYLIC ACID, 2-HYDROXY-
- acidum citricum
- Acidum citricum
- ACIDUM CITRICUM \[WHO-IP LATIN\]
- acidum citricum monohydrate
- Acidum citricum monohydrate
- acidum citricum who ip latin
- aciletten
- Aciletten
- anhydrous citric acid
- Anhydrous citric acid
- ANHYDROUS CITRIC ACID \[II\]
- ANHYDROUS CITRIC ACID \[JAN\]
- ANHYDROUS CITRIC ACID \[MART.\]
- ANHYDROUS CITRIC ACID \[USP MONOGRAPH\]
- anhydrous citric acid 1197 0 mg potassium bicarbonate 967 5 mg sodium citrate anhydrous 835 5 mg
- anhydrous citric acid ii
- anhydrous citric acid jan
- anhydrous citric acid mart
- anhydrous citric acid usp monograph
- b1650
- B1650
- citrate
- Citrate

And 59 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- A09AB04

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1261)

**CAS registry numbers**

- 77-92-9

**ChEMBL ID**

CHEMBL1261

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1261)

**InChIKey**

KRKNYBCHXYNGOX-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1261)

**FDA ingredient codes (UNII)**

- XF417D3PSL

### PubChem compound IDs (3)

- 311
- 19782904
- 88113319

### RxNorm IDs (RxCUI) (3)

- 21183
- 221946
- 1312366

## Regulatory information

### United States

**Applicant**

UNITED GUARDIAN

**Approval date**

2 Oct 1990

**Application number**

NDA019481

### Other regulatory facts

**Patents**

0

**Designations**

1

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

citric acid

**Type**

Metabolite

#### Administration routes

- Oral
- topical

### Mechanisms of action

- **Action**  
Agonist

**Action type**  
Agonist

**Target**  
TRPP2

**Gene symbol**  
PKD2L1

**Protein identifier**  
Q9P0L9

**Median affinity**

1.7

**Affinity units**  
pEC50

### Investigated indications (6)

- **Condition**  
Kidney Calculi

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0004253

**Subject identifier**  
D007669
- **Condition**  
Renal Insufficiency

**Highest recorded phase**  
3

**Condition identifier**  
HP:0000083

**Subject identifier**  
D051437
- **Condition**  
Nephrocalcinosis

**Highest recorded phase**  
3

**Condition identifier**  
HP:0000121

**Subject identifier**  
D009397
- **Condition**  
Tension-Type Headache

**Highest recorded phase**  
2

**Condition identifier**  
HP:0012228

**Subject identifier**  
D018781
- **Condition**  
Cataract

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0005129

**Subject identifier**  
D002386
- **Condition**  
Osteoarthritis

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0005178

**Subject identifier**  
D010003

### Open Targets indications (17)

- **Condition identifier**  
EFO\_0000384
- **Condition identifier**  
EFO\_0006859
- **Condition identifier**  
EFO\_0009518
- **Condition identifier**  
EFO\_0009909

**Highest recorded phase**  
2
- **Condition identifier**  
HP\_0000083
- **Condition identifier**  
HP\_0002901
- **Condition identifier**  
HP\_0012228
- **Condition identifier**  
MONDO\_0001106
- **Condition identifier**  
MONDO\_0001567

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0002492

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005011

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005178

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005372
- **Condition identifier**  
MONDO\_0005647

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0024647
- **Condition identifier**  
MONDO\_0100192

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0850098

### Reported adverse events (25)

- **Event**  
analgesic asthma syndrome

**Reports**  
1

**Reporting signal score**

5.93494
- **Event**  
anorectal discomfort

**Reports**  
2

**Reporting signal score**

7.0949
- **Event**  
b precursor type acute leukaemia

**Reports**  
2

**Reporting signal score**

11.4885
- **Event**  
blood calcium decreased

**Reports**  
3

**Reporting signal score**

7.38152
- **Event**  
colitis

**Reports**  
6

**Reporting signal score**

12.3586
- **Event**  
dermatitis

**Reports**  
3

**Reporting signal score**

6.66792
- **Event**  
device temperature issue

**Reports**  
1

**Reporting signal score**

7.83919
- **Event**  
drug hypersensitivity

**Reports**  
13

**Reporting signal score**

13.5491
- **Event**  
graft versus host disease in skin

**Reports**  
2

**Reporting signal score**

7.03147
- **Event**  
haemorrhage

**Reports**  
7

**Reporting signal score**

10.377
- **Event**  
hyponatraemic coma

**Reports**  
1

**Reporting signal score**

6.74087
- **Event**  
imaging procedure artifact

**Reports**  
3

**Reporting signal score**

28.0541
- **Event**  
intestinal congestion

**Reports**  
1

**Reporting signal score**

6.11171
- **Event**  
medical device site fibrosis

**Reports**  
1

**Reporting signal score**

6.17835
- **Event**  
mucosal dryness

**Reports**  
2

**Reporting signal score**

7.61942
- **Event**  
nasogastric output high

**Reports**  
1

**Reporting signal score**

7.23318
- **Event**  
ochronosis

**Reports**  
1

**Reporting signal score**

6.21341
- **Event**  
oropharyngeal discolouration

**Reports**  
1

**Reporting signal score**

7.4338
- **Event**  
product barcode issue

**Reports**  
4

**Reporting signal score**

25.1062
- **Event**  
product label issue

**Reports**  
2

**Reporting signal score**

7.33843
- **Event**  
radiation alopecia

**Reports**  
2

**Reporting signal score**

17.4374
- **Event**  
swollen tongue

**Reports**  
4

**Reporting signal score**

7.08767
- **Event**  
tongue discomfort

**Reports**  
2

**Reporting signal score**

7.64279
- **Event**  
toxic epidermal necrolysis

**Reports**  
9

**Reporting signal score**

29.7269
- **Event**  
upper airway obstruction

**Reports**  
2

**Reporting signal score**

8.87596

### Trial references (6)

- NCT00249951  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00249951)
- NCT01012349  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01012349)
- NCT01421160  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01421160)
- NCT01602068  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01602068)
- NCT01754779  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01754779)
- NCT01962116  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01962116)

## Dosing

**Dose**

1 bottle

**Route**

Oral

**How often**

Split-dose regimen

### Conditions of use (6)

- Do not drink alcohol
- Do not drink anything colored red or purple
- Do not eat solid food or dairy on the day before colonoscopy
- No solid food or dairy
- Stop liquids at least 2 hours before colonoscopy
- Take with clear liquids

## Chemical properties

**Hydrogen bond acceptors**

4

**Hydrogen bond donors**

4

**Polar surface area**

132.13

**Calculated partition coefficient (ALogP)**

\-1.25

**Calculated partition coefficient (XLogP)**

\-1.7

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

5

**Heavy atoms**

13

**Molecular formula**

C6H8O7

**Monoisotopic mass**

192.02700259

**Natural product**

Yes

## National Drug Codes

- 0121-0595
- 0121-1190
- 0327-0012
- 0942-0641
- 0942-6305
- 0942-6307
- 0942-6308
- 0942-6312
- 0942-6316
- 0942-6320
- 0942-6322
- 0942-6326
- 0942-9001
- 0942-9201
- 0942-9202
- 0942-9393
- 0942-9394
- 0942-9398
- 50268-182
- 50268-183
- 53877-108
- 53877-109
- 53877-110
- 60687-832
- 60687-834

And 9 more, listed on the interactive page.

## Evidence counts

**Recorded assays**

2,354

**Active assays**

41

### Active assay types (3)

- Confirmatory
- Other
- Screening

## Pharmacologic actions

- Anticoagulants  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000925.html)
- Calcium Chelating Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D065096.html)

## Related records

### Trials (58)

- 68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
- 68Ga-citrate PET/MR Imaging for Glioma
- [A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants](https://trialight.com/data/trial/a-bioequivalence-study-of-citrate-free-mirikizumab-ly3074828-5d425438-f7df-47c3-8054-edc0cdafae5f.md)
- A Cross-sectional Study to Measure Cough in Severe Asthma
- A Dose-Response Controlled Trial of Bevifibatide for Acute Ischemic Stroke
- A Pilot Study of Commercially Available Bowel Preparation Regimens Packaged and Ingested Via Vegan Capsules
- A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy
- A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy
- A Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy
- A Study of Two Formulations (Both Refrigerated and Room Temperature) Using an Autoinjector Device in Healthy Participants
- Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
- Antibiotic Lock Solutions in the Prevention of Catheter Related Bacteremia
- Arterial pH and Total Body Nitrogen Balances in APD
- Biological and Clinical Measurements Following Systemic Leakage When a Citrate or Heparin Lock is Used
- Bismuth Based Quadruple Therapy 10 Days in Children
- Bone in CKD Alkali Response (BICARb Pilot Trial)
- Bowel Preparation in Elective Pediatric Colorectal Surgery
- Citrate 4% Versus Heparinised Saline in Preventing Peripherally Inserted Central Catheter (PICC) Occlusions
- Citrate Anticoagulation in Renal Replacement Therapy: Impact of a High Post-filter Calcium Target on Efficacy
- Citrate Versus Heparin Anticoagulation: Effect on Molecules Clearances

### In development for (6)

- Acute kidney injury Phase 3
- Cataract Phase 2
- [Kidney failure](https://trialight.com/data/condition/kidney-failure-f26737b4-3a55-50be-b6c3-b76514cb5067.md) Phase 3
- Nephrocalcinosis Phase 3
- Nephrolithiasis Phase 2
- [Osteoarthritis](https://trialight.com/data/condition/osteoarthritis-e8c428fb-1597-576d-bcf0-f3b27ebc6a00.md) Phase 1

### Other linked conditions (3)

- [Crohn disease](https://trialight.com/data/condition/crohn-disease-f7aa2cd8-9680-56b5-858c-2b75f88fb0d0.md)
- [Head and neck cancer](https://trialight.com/data/condition/head-and-neck-cancer-3a2645b9-a3db-5103-b6f8-5d2ec40c5339.md)
- Urolithiasis

---

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