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Drug ReportsClarithromycin
Clarithromycin
/ Clarithromycin /, Clarithromycin, Omeclamox-pak, Voquezna Triple (clarithromycin) is a small molecule pharmaceutical. Clarithromycin was first approved as Biaxin on 1991-10-31. It is used to treat bacterial infections, bronchitis, chlamydia infections, duodenal ulcer, and haemophilus infections amongst others in the USA. The pharmaceutical is active against androgen receptor.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
stomatognathic diseasesD009057
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Clarithromycin (discontinued: Biaxin, Clarithromycin)
Combinations
Lansoprazole, amoxicillin clarithromycin, Voquezna triple (discontinued: Lansoprazole, amoxicillin clarithromycin, Omeclamox-pak, Prevpac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Clarithromycin
Tradename
Company
Number
Date
Products
BIAXINAbbVieN-050662 DISCN1991-10-31
2 products, RLD
BIAXINAbbVieN-050698 DISCN1993-12-23
3 products, RLD
BIAXIN XLAbbVieN-050775 DISCN2000-03-03
1 products, RLD
Hide discontinued
Amoxicillin
+
Clarithromycin
+
Lansoprazole
Tradename
Company
Number
Date
Products
PREVPAC (COPACKAGED)TakedaN-050757 DISCN1997-12-02
1 products, RLD
Hide discontinued
Amoxicillin
+
Clarithromycin
+
Omeprazole
Tradename
Company
Number
Date
Products
OMECLAMOX-PAKCumberland PharmaceuticalsN-050824 DISCN2011-02-08
1 products, RLD
Hide discontinued
Amoxicillin
+
Clarithromycin
+
Vonoprazan fumarate
Tradename
Company
Number
Date
Products
VOQUEZNA TRIPLE PAKPhathom PharmaceuticalsN-215152 RX2022-05-03
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
biaxinNew Drug Application2012-02-22
clarithromycinANDA2025-02-05
clarithromycin clarithromycinANDA2018-02-14
clarithromycin extended release2008-08-08
lansoprazole, amoxicillin, clarithromycinANDA2024-01-23
omeclamox-pakNew Drug Application2023-08-17
prevpacNew Drug Application2010-03-15
voquezna dual pak voquezna triple pakNew Drug Application2024-08-05
Agency Specific
FDA
EMA
Expiration
Code
AMOXICILLIN / CLARITHROMYCIN / VONOPRAZAN FUMARATE, VOQUEZNA TRIPLE PAK, PHATHOM
2032-05-03GAIN
2027-05-03NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Amoxicillin / Clarithromycin / Vonoprazan Fumarate, Voquezna Triple Pak, Phathom
91864112030-08-11DP
79774882028-08-11DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD04: Pantoprazole, amoxicillin and clarithromycin
— A02BD05: Omeprazole, amoxicillin and clarithromycin
— A02BD06: Esomeprazole, amoxicillin and clarithromycin
— A02BD07: Lansoprazole, amoxicillin and clarithromycin
— A02BD09: Lansoprazole, clarithromycin and tinidazole
— A02BD11: Pantoprazole, amoxicillin, clarithromycin and metronidazole
— A02BD12: Rabeprazole, amoxicillin and clarithromycin
— A02BD14: Vonoprazan, amoxicillin and clarithromycin
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01F: Macrolides, lincosamides and streptogramins
— J01FA: Macrolides
— J01FA09: Clarithromycin
HCPCS
No data
Clinical
Clinical Trials
523 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—920398873219
Helicobacter infectionsD016481EFO_1000961—110204438106
Communicable diseasesD003141——3916292982
GastritisD005756EFO_0000217K29.7231126848
Healthy volunteers/patients———34——1641
Mycobacterium infectionsD009164—A31.9110102424
PneumoniaD011014EFO_0003106J1811135322
Mycobacterium avium-intracellulare infectionD015270EFO_0007386—1773320
DyspepsiaD004415EFO_0008533K3021112420
Hiv infectionsD015658EFO_0000764B204541317
Show 67 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101—C90.02184——22
Plasma cell neoplasmsD054219——2184——22
LymphomaD008223—C85.9251—412
Covid-19D000086382—U07.1124—17
Parkinson diseaseD010300EFO_0002508G20211—25
Aggressive periodontitisD010520EFO_0006342K05.2—22—24
AggressionD000374EFO_0003015——22—24
Acute diseaseD000208————1—34
Buruli ulcerD054312EFO_1001281A31.1—32——3
Non-hodgkin lymphomaD008228—C85.9——1—23
Show 41 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell lymphoma marginal zoneD018442—C88.4—3——47
NeoplasmsD009369—C8031———4
B-cell lymphomaD016393——11——13
Disorders of excessive somnolenceD006970—G47.1—2——13
Lung neoplasmsD008175—C34.90—2———2
NarcolepsyD009290EFO_0000614G47.4—2———2
Idiopathic hypersomniaD020177—G47.11—2———2
LeukemiaD007938—C9511———2
Lymphoid leukemiaD007945—C9111———2
Coronavirus infectionsD018352EFO_0007224B34.2—1———1
Show 20 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD004347——8———19
PharmacokineticsD010599——5————5
Long qt syndromeD008133HP_0001657I45.811———12
Venous thromboembolismD054556EFO_0004286I741————1
ThromboembolismD013923——1————1
OsteomyelitisD010019EFO_0003102M861————1
Prostatic neoplasmsD011471—C611————1
Neoplasm metastasisD009362EFO_0009708—1————1
Oxidative stressD018384EFO_1001905—1————1
MycosesD009181—B35-B491————1
Show 7 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TracheitisD014136EFO_0007518—————33
MalnutritionD044342EFO_0008572E40-E46————22
Patient complianceD010349——————22
Gastrointestinal microbiomeD000069196——————22
DeliriumD003693—R41.0————11
Torsades de pointesD016171EFO_0005307I47.21————11
Staphylococcal infectionsD013203—A49.01————11
Staphylococcus aureusD013211NCBITaxon_1280—————11
Critical illnessD016638——————11
Wounds and injuriesD014947—T14.8————11
Show 22 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameClarithromycin
INNclarithromycin
Description
Clarithromycin is the 6-O-methyl ether of erythromycin A, clarithromycin is a macrolide antibiotic used in the treatment of respiratory-tract, skin and soft-tissue infections. It is also used to eradicate Helicobacter pylori in the treatment of peptic ulcer disease. It prevents bacteria from growing by interfering with their protein synthesis. It has a role as an antibacterial drug, a protein synthesis inhibitor, an environmental contaminant and a xenobiotic.
Classification
Small molecule
Drug classantibiotics (Streptomyces strain)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(OC)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@]1(C)O
Identifiers
PDB—
CAS-ID81103-11-9
RxCUI—
ChEMBL IDCHEMBL1741
ChEBI ID3732
PubChem CID84029
DrugBankDB01211
UNII IDH1250JIK0A (ChemIDplus, GSRS)
Target
Agency Approved
AR
AR
Organism
Homo sapiens
Gene name
AR
Gene synonyms
DHTR, NR3C4
NCBI Gene ID
Protein name
androgen receptor
Protein synonyms
Dihydrotestosterone receptor, Nuclear receptor subfamily 3 group C member 4
Uniprot ID
Mouse ortholog
Ar (11835)
androgen receptor (P19091)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Clarithromycin
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Amoxicillin
+
Lansoprazole
Total medical expenditures per year (USD, in millions)
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Clarithromycin
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Amoxicillin
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Omeprazole
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Clarithromycin
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 27,554 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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31,159 adverse events reported
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