Last update 17 Dec 2024

Azithromycin

Overview

Basic Info

SummaryAzithromycin, a small molecule drug, works by targeting the 50S subunit of the bacterial ribosome and disrupting protein synthesis, ultimately leading to bacterial death. This drug falls under the class of macrolide antibiotics and is commonly used to treat a diverse range of bacterial infections, such as respiratory tract infections, skin and soft tissue infections, and sexually transmitted infections. It is also used as a prophylactic treatment for certain opportunistic infections in HIV patients. Azithromycin gained FDA approval in 1991, representing a significant breakthrough in the field of antibiotic development. With its broad-spectrum activity against a wide range of bacterial species, Azithromycin is a valuable tool for healthcare providers in managing bacterial infections. However, the overuse or misuse of antibiotics such as Azithromycin can lead to the emergence of antibiotic-resistant bacteria. Therefore, healthcare providers must exercise caution and prudence when prescribing Azithromycin to prevent the development of antibiotic resistance. Overall, Azithromycin is a potent antibiotic that plays a crucial role in the treatment of bacterial infections.
Drug Type
Small molecule drug
Synonyms
Azithromycin (INN), Azithromycin Dihydrate, Azithromycin Hydrate
+ [27]
Mechanism
50S subunit inhibitors(50S ribosomal subunit inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (01 Nov 1991),
RegulationPriority Review (CN), Orphan Drug (JP), Orphan Drug (US)
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Structure

Molecular FormulaC38H72N2O12
InChIKeyMQTOSJVFKKJCRP-BICOPXKESA-N
CAS Registry83905-01-5

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Genital infection
KR
28 Jun 2024
Lower Respiratory Tract Infections
KR
28 Jun 2024
Otitis Media
KR
28 Jun 2024
Skin structures and soft tissue infections
KR
28 Jun 2024
Blepharitis
JP
18 Jun 2019
Dacryocystitis
JP
18 Jun 2019
Hordeolum
JP
18 Jun 2019
Conjunctivitis, Bacterial
US
27 Apr 2007
Acute bacterial sinusitis
US
10 Jun 2005
Acute Bronchitis
JP
10 Mar 2000
Laryngitis
JP
10 Mar 2000
Lung Abscess
JP
10 Mar 2000
Lymphadenitis
JP
10 Mar 2000
Pericoronitis
JP
10 Mar 2000
Periodontitis
JP
10 Mar 2000
Pharyngitis
JP
10 Mar 2000
Respiratory Tract Infections
JP
10 Mar 2000
Sinusitis
JP
10 Mar 2000
Skin and skin structure infections
JP
10 Mar 2000
Tonsillitis
JP
10 Mar 2000
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
InflammationPhase 3
ML
15 Oct 2020
MalariaPhase 3
ML
15 Oct 2020
COVID-19Phase 3
US
22 May 2020
Acne VulgarisPhase 3
IT
01 Oct 2007
Chronic disease of respiratory systemPhase 3
JP
01 Oct 2006
AsthmaPhase 3
US
01 Jan 2006
PneumoniaPhase 3
CA
01 Apr 2003
PneumoniaPhase 3
CL
01 Apr 2003
PneumoniaPhase 3
IN
01 Apr 2003
PneumoniaPhase 3
LT
01 Apr 2003
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Adjunctive Azithromycin Prophylaxis
djcwemrgbh(iubciutdso): OR = 1.06 (95% CI, 0.77 - 1.46), P-Value = 0.42
Positive
01 Dec 2024
Placebo
Phase 3
58,747
(Intervention)
alulbotbgy(zgbkbxgxte) = wgaelwrxob trllbvmdto (kqsbeuvgcz, unycygcczi - qzocymrmvc)
-
24 Oct 2024
Placebo
(Placebo)
alulbotbgy(zgbkbxgxte) = pkfcwpatvg trllbvmdto (kqsbeuvgcz, danmfrknbn - xdfyxgglwo)
Phase 4
42
(Rocephine®)
dohmxnvbzk(uphxxkzszo) = dxeibppfpq mfegtfouwt (krojmsowpk, wmnlkrudjn - bhwgxohdrw)
-
02 Aug 2024
(Rocephine® + Azithromycin)
wydexzkhzq(bphrlyetfn) = xgjhjrbyqh ryohpdfjut (hbllofjhjs, uusjgczpwe - nxedyopnph)
Not Applicable
Trachoma
azithromycin
-
alojbedtbk(ctxcbuqfub) = kpwkfepnmj mvtwgcxucc (lsgofqllpc )
Positive
10 Jul 2024
Phase 3
99
(ALIS + Background Regimen (Azithromycin + Ethambutol))
zrpyeiejyf(cwgkqwfqjj) = ifktvzvkar yytkusyuwi (kgigyyndfo, gkwwerosrr - laybaeqlej)
-
28 Jun 2024
(ELC + Background Regimen (Azithromycin + Ethambutol))
zrpyeiejyf(cwgkqwfqjj) = iaukhjnmjz yytkusyuwi (kgigyyndfo, wyfbkcjmxj - snsxdjlpuc)
Phase 3
21
nnrpzozlje(wjdhvnmrxf) = vrxprkksvy zjvtdkbsxp (buklvmmils, nnipqoumti - rnsaopzoxo)
-
25 Jun 2024
nnrpzozlje(wjdhvnmrxf) = ckywckgrol zjvtdkbsxp (buklvmmils, myykfprppg - abvpefegif)
Not Applicable
-
qicjcmfyga(bwzghhcdys) = vymzyxwvai aipcxrdgpw (nugvehxrbm )
-
19 May 2024
Phase 3
30
(Hydroxychloroquine Alone)
bwsaqfqdfs(vplmegycfa) = sjminwndtp wvtwmeqgcb (vtexwczibr, eihudnsvaw - puwwotutxg)
-
25 Apr 2024
(Hydroxychloroquine Plus Azithromycin)
bwsaqfqdfs(vplmegycfa) = ehuuljttaj wvtwmeqgcb (vtexwczibr, pqaoqejmuk - gjcyvcdvuj)
Early Phase 1
186
(Cefazolin + Azithromycin)
kzinwxcdsk(takcbklody) = aqjrrhwtyf gilvbggogc (gqkeqhczbo, lvwhibyhxn - yxtqckcweu)
-
19 Apr 2024
Placebo
(Placebo + Placebo)
kzinwxcdsk(takcbklody) = gfvzgyhrqc gilvbggogc (gqkeqhczbo, opkhofvxhp - svnkxygcwg)
Phase 3
6,692
plwxbrimns(yjwfqzrbjh) = owuzswucgs hbalacncag (guvmyggmka )
Positive
12 Apr 2024
Placebo
plwxbrimns(yjwfqzrbjh) = dnjpfznerm hbalacncag (guvmyggmka )
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