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Drug ReportsCitric acid monohydrate
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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3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
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
+
Sodium carbonate
Tradename
Company
Number
Date
Products
IRRIGATING SOLUTION G IN PLASTIC CONTAINERBaxterN-018519 DISCN1982-06-22
1 products
UROLOGIC G IN PLASTIC CONTAINERHospiraN-018904 DISCN1983-05-27
1 products
Hide discontinued
Citric acid
+
Magnesium oxide
+
Sodium picosulfate
Tradename
Company
Number
Date
Products
CLENPIQFerring PharmaceuticalsN-209589 RX2017-11-28
1 products, RLD, RS
Show 1 discontinued
Citric acid
+
Lactic acid
+
Potassium bitartrate
Tradename
Company
Number
Date
Products
PHEXXIEvofem BiosciencesN-208352 RX2020-05-22
1 products, RLD, RS
Citric acid
+
Gluconolactone
+
Magnesium carbonate
Tradename
Company
Number
Date
Products
RENACIDINUnited GuardianN-019481 RX1990-10-02
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
2080 dentistry night freshOTC monograph final2017-02-03
abstralNew Drug Application2014-11-30
acdANDA2025-01-22
acd blood-pack units (pl 146 plastic)New Drug Application2022-04-27
acd-aNew Drug Application2022-11-01
additive formula 3New Drug Application2025-01-24
adea gargleunapproved drug other2018-03-26
adsol red cell preservationNew Drug Application2022-11-22
adsol red cell preservation solution system in plastic container (pl 146 plastic)New Drug Application2022-11-02
adsol red cell preservation system in plastic container (pl 146 plastic)New Drug Application2019-05-08
Show 216 more
Agency Specific
FDA
EMA
Expiration
Code
CITRIC ACID / LACTIC ACID / POTASSIUM BITARTRATE, PHEXXI, EVOFEM INC
2023-05-22NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Citric Acid / Magnesium Oxide / Sodium Picosulfate, Clenpiq, Ferring Pharms Inc
98272312034-06-26DPU-2162
106248792034-06-23DP
111917532034-06-23U-3261
Citric Acid / Lactic Acid / Potassium Bitartrate, Phexxi, Evofem Inc
105688552033-03-15U-1
113379892033-03-15U-1
114396102033-03-15DS, DP
67062762023-09-06DP
Citric Acid / Magnesium Oxide / Sodium Picosulfate, Prepopik, Ferring Pharms Inc
84503382028-10-10DP
84810832028-10-10DP
ATC Codes
A: Alimentary tract and metabolism drugs
A09: Digestives, incl. enzymes
A09A: Digestives, incl. enzymes
A09AB: Acid preparations, digestives
A09AB04: Citric acid
HCPCS
No data
Clinical
Clinical Trials
2224 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 neoplasmsD001943EFO_0003869C5093853114113
InfertilityD007246EFO_00005451018183735108
InfectionsD007239EFO_000054421016382385
Polycystic ovary syndromeD011085EFO_0000660E28.261319232984
Erectile dysfunctionD007172EFO_0004234F52.211481039978
SyndromeD013577479163366
Pulmonary hypertensionD006976EFO_0001361I27.2031922151063
Healthy volunteers/patients342322061
Acute kidney injuryD058186N172553446
Chronic kidney failureD007676EFO_0003884N18.6761091139
Show 251 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277C80.0103222359
Squamous cell carcinoma of head and neckD0000771951118931
AdenocarcinomaD000230911927
Squamous cell carcinomaD002294814926
Multiple myelomaD009101C90.010162326
Lung neoplasmsD008175C34.904137224
Covid-19D000086382U07.13961224
HypogonadismD007006E23.03117223
Uterine cervical neoplasmsD002583837219
Adenosquamous carcinomaD01819665616
Show 249 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CoughD003371R051910
Central nervous system neoplasmsD0165432518
Motor activityD009043EFO_00039401157
Asphyxia neonatorumD001238EFO_1000824P843317
Nervous system neoplasmsD0094231416
Small cell lung carcinomaD055752346
Hemostatic disordersD0201411156
HypercholesterolemiaD0069371135
AlopeciaD000505L641135
GliomaD005910EFO_0000520314
Show 182 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pregnancy rateD018873134
Biological availabilityD001682134
FistulaD005402123
ArthritisD001168EFO_0005856M05-M14213
Gastrointestinal neoplasmsD005770C26.9213
Pulmonary embolismD011655EFO_0003827I2622
Pure autonomic failureD054970112
Ovarian hyperstimulation syndromeD016471112
Congenital abnormalitiesD000013EFO_0003915Q89.9112
Intraabdominal infectionsD059413112
Show 64 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatic insufficiencyD04855066
Chronic coughD000096822R05.355
Blood coagulation disordersD001778EFO_0009314D68.955
Hemophilia aD006467EFO_0007267D6644
NauseaD009325R11.033
PneumoniaD011014EFO_0003106J1833
HyperthermiaD00008446233
Hemophilia bD002836D6733
Rare diseasesD03558333
Weight lossD01543133
Show 295 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCitric acid
INNdimpylate
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)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C(O)CC(O)(CC(=O)O)C(=O)O
Identifiers
PDB
CAS-ID77-92-9
RxCUI
ChEMBL IDCHEMBL1261
ChEBI ID30769
PubChem CID311
DrugBankDB04272
UNII IDXF417D3PSL (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
Revenue by drug
$
£
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Tabular view
Estimated US medical usage
Citric acid
+
Citric acid monohydrate
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 442,329 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, Citranatal harmony 3.0, Citranatal medley, Fareston, Fentanyl buccal, Fentanyl citrate, Hepzato kit, Lazanda, Melphalan hydrochloride, Soltamox, Sufentanil citrate, Tamoxifen citrate, Toremifene citrate, Transmucosal fentanyl citrate
Adverse Events
Top Adverse Reactions
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48,741 adverse events reported
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