Citric acid
/ /, Clenpiq, G, Idkit:hp, Phexxi, Renacidin (citric acid) is a small molecule pharmaceutical. Citric acid was first approved as Irrigating solution g in plastic container on 1982-06-22. It is used to treat renal tubular acidosis and urination disorders in the USA. It is known to target polycystin-2-like protein 1 and transient receptor potential cation channel subfamily V member 4.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Combinations
Clenpiq, Phexxi, Picosulfate, magnesium oxide anhydrous citric acid, Renacidin (discontinued: Irrigating solution g, Prepopik, Urologic g)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Citric acid
+
Magnesium oxide
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Sodium carbonate
Citric acid
+
Magnesium oxide
+
Sodium picosulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CLENPIQ | Ferring Pharmaceuticals | N-209589 RX | 2017-11-28 | 1 products, RLD, RS |
Show 1 discontinued
Citric acid
+
Lactic acid
+
Potassium bitartrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PHEXXI | Evofem Biosciences | N-208352 RX | 2020-05-22 | 1 products, RLD, RS |
Citric acid
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Gluconolactone
+
Magnesium carbonate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RENACIDIN | United Guardian | N-019481 RX | 1990-10-02 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 2080 dentistry night fresh | OTC monograph final | 2017-02-03 |
| abstral | New Drug Application | 2014-11-30 |
| acd | ANDA | 2026-06-15 |
| acd blood-pack units (pl 146 plastic) | New Drug Application | 2022-04-27 |
| acd-a | New Drug Application | 2025-11-25 |
| acetaminophen and diphenhydramine citrate | C200263 | 2025-10-02 |
| additive formula 3 | New Drug Application | 2026-01-30 |
| adea gargle | unapproved drug other | 2018-03-26 |
| adsol red cell preservation | New Drug Application | 2026-10-12 |
| adsol red cell preservation solution system in plastic container (pl 146 plastic) | New Drug Application | 2022-11-02 |
Show 225 more
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| urination disorders | — | D014555 | — |
| renal tubular acidosis | — | D000141 | N25.89 |
| dermatitis | — | D003872 | L30.9 |
| facial dermatoses | — | D005148 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CITRIC ACID / LACTIC ACID / POTASSIUM BITARTRATE, PHEXXI, EVOFEM INC | |||
| 2023-05-22 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Citric Acid / Magnesium Oxide / Sodium Picosulfate, Clenpiq, Ferring Pharms Inc | |||
| 9827231 | 2034-06-26 | DP | U-2162 |
| 10624879 | 2034-06-23 | DP | |
| 11191753 | 2034-06-23 | U-3261 | |
| Citric Acid / Lactic Acid / Potassium Bitartrate, Phexxi, Evofem Inc | |||
| 10568855 | 2033-03-15 | U-1 | |
| 11337989 | 2033-03-15 | U-1 | |
| 11439610 | 2033-03-15 | DS, DP | |
| 6706276 | 2023-09-06 | DP | |
| Citric Acid / Magnesium Oxide / Sodium Picosulfate, Prepopik, Ferring Pharms Inc | |||
| 8450338 | 2028-10-10 | DP | |
| 8481083 | 2028-10-10 | DP | |
HCPCS
No data
Clinical
Clinical Trials
2381 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 9 | 37 | 54 | 1 | 14 | 113 |
| Infertility | D007246 | EFO_0000545 | — | 10 | 18 | 18 | 37 | 32 | 105 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 6 | 13 | 20 | 24 | 31 | 88 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 15 | 10 | 11 | 40 | 10 | 84 |
| Infections | D007239 | EFO_0000544 | — | 2 | 9 | 15 | 39 | 21 | 82 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 3 | 20 | 23 | 15 | 11 | 65 |
| Healthy volunteers/patients | — | — | — | 36 | 2 | 3 | 2 | 21 | 64 |
| Syndrome | D013577 | — | — | 2 | 5 | 8 | 14 | 33 | 60 |
| Acute kidney injury | D058186 | — | N17 | 3 | 2 | 5 | 6 | 41 | 56 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 7 | 6 | 10 | 9 | 14 | 42 |
Show 258 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 11 | 19 | 10 | — | 1 | 34 |
| Carcinoma | D002277 | — | C80.0 | 5 | 21 | 7 | — | 3 | 33 |
| Multiple myeloma | D009101 | — | C90.0 | 10 | 16 | 2 | — | 3 | 26 |
| Covid-19 | D000086382 | — | U07.1 | 3 | 10 | 6 | — | 12 | 25 |
| Adenocarcinoma | D000230 | — | — | 9 | 8 | 8 | — | — | 24 |
| Squamous cell carcinoma | D002294 | — | — | 7 | 12 | 8 | — | — | 24 |
| Hypogonadism | D007006 | — | E23.0 | 3 | 11 | 7 | — | 2 | 23 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 10 | 5 | — | 3 | 19 |
| Uterine cervical neoplasms | D002583 | — | — | 8 | 3 | 6 | — | 2 | 18 |
| Oropharyngeal neoplasms | D009959 | — | — | 2 | 14 | 6 | — | — | 17 |
Show 238 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Motor activity | D009043 | EFO_0003940 | — | 1 | 1 | — | — | 8 | 10 |
| Brain diseases | D001927 | — | G93.40 | 3 | 2 | — | — | 3 | 8 |
| Central nervous system neoplasms | D016543 | — | — | 2 | 5 | — | — | 1 | 8 |
| Ischemia | D007511 | EFO_0000556 | — | 3 | 3 | — | — | 2 | 7 |
| Head and neck neoplasms | D006258 | — | — | 3 | 4 | — | — | 2 | 7 |
| Nervous system neoplasms | D009423 | — | — | 1 | 4 | — | — | 1 | 6 |
| Small cell lung carcinoma | D055752 | — | — | 3 | 4 | — | — | — | 6 |
| Dyspnea | D004417 | — | R06.0 | 1 | 2 | — | — | 2 | 5 |
| Pharmacokinetics | D010599 | — | — | 4 | 1 | — | — | 1 | 5 |
| Hemostatic disorders | D020141 | — | — | 1 | 1 | — | — | 4 | 5 |
Show 180 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy rate | D018873 | — | — | 1 | — | — | — | 3 | 4 |
| Fistula | D005402 | — | — | 1 | — | — | — | 3 | 4 |
| Biological availability | D001682 | — | — | 1 | — | — | — | 3 | 4 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 2 | — | — | — | 1 | 3 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 2 | — | — | — | 1 | 3 |
| Cystadenocarcinoma | D003536 | — | — | 1 | — | — | — | 1 | 2 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | 2 | — | — | — | — | 2 |
| Pure autonomic failure | D054970 | — | — | 1 | — | — | — | 1 | 2 |
| Brain ischemia | D002545 | EFO_0003883 | I67.82 | 2 | — | — | — | — | 2 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | 1 | 2 |
Show 71 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic cough | D000096822 | — | R05.3 | — | — | — | — | 5 | 5 |
| Hepatic insufficiency | D048550 | — | — | — | — | — | — | 5 | 5 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 4 | 4 |
| Nausea | D009325 | — | R11.0 | — | — | — | — | 3 | 3 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 3 | 3 |
| Hyperthermia | D000084462 | — | — | — | — | — | — | 3 | 3 |
| Hemophilia b | D002836 | — | D67 | — | — | — | — | 3 | 3 |
| Rare diseases | D035583 | — | — | — | — | — | — | 3 | 3 |
| Weight loss | D015431 | — | — | — | — | — | — | 3 | 3 |
| Dehydration | D003681 | — | E86.0 | — | — | — | — | 3 | 3 |
Show 320 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Citric acid |
| INN | dimpylate |
| Description | Idkit:hp (citric acid) is a small molecule pharmaceutical. Citric acid was first approved as Idkit:hp on 2002-12-17. It is used to treat renal tubular acidosis and urination disorders in the USA. It is known to target polycystic kidney disease 2-like 1 protein, transient receptor potential cation channel subfamily V member 4, and nectin-1. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)CC(O)(CC(=O)O)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 77-92-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1261 |
| ChEBI ID | 30769 |
| PubChem CID | 311 |
| DrugBank | DB04272 |
| UNII ID | XF417D3PSL (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
PKD2L1
PKD2L1
NECTIN1
NECTIN1
Organism
Homo sapiens
Gene name
PKD2L1
Gene synonyms
PKD2L, PKDL, TRPP3
NCBI Gene ID
Protein name
polycystin-2-like protein 1
Protein synonyms
Polycystic kidney disease 2-like 1 protein, Polycystin-2 homolog, polycystin-2L1, Polycystin-L, Polycystin-L1, transient receptor potential cation channel, subfamily P, member 3
Uniprot ID
Mouse ortholog
Pkd2l1 (329064)
polycystin-2-like protein 1; polycystic kidney disease 2-like 1 protein (Q80ZH4)
Variants
No data
Financial
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Tabular view
Estimated US medical usage
Citric acid
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Citric acid monohydrate
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
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Additional graphs summarizing 463,569 documents
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Safety
Black-box Warning
Black-box warning for: Abstral, Citranatal, Citranatal assure, Citranatal essence, Citranatal harmony, Citranatal harmony 2.1, Fareston, Fentanyl citrate, Hepzato kit, Lazanda, Lithium, Melphalan hydrochloride, Soltamox, Sufentanil citrate, Tamoxifen citrate, Tofacitinib, Tofacitinib citrate, Toremifene citrate, Transmucosal fentanyl citrate
Adverse Events
Top Adverse Reactions
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52,884 adverse events reported
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