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 + [31] |
Target |
Action inhibitors |
Mechanism 50S subunit inhibitors(50S ribosomal subunit inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (01 Nov 1991), |
RegulationOrphan Drug (United States), Orphan Drug (Japan), Priority Review (China) |
Molecular FormulaC38H72N2O12 |
InChIKeyMQTOSJVFKKJCRP-BICOPXKESA-N |
CAS Registry83905-01-5 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D07486 | Azithromycin |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Genital infection | South Korea | 28 Jun 2024 | |
| Lower Respiratory Tract Infections | South Korea | 28 Jun 2024 | |
| Otitis Media | South Korea | 28 Jun 2024 | |
| Skin structures and soft tissue infections | South Korea | 28 Jun 2024 | |
| Blepharitis | Japan | 18 Jun 2019 | |
| Dacryocystitis | Japan | 18 Jun 2019 | |
| Hordeolum | Japan | 18 Jun 2019 | |
| Pneumonia | Japan | 01 Jul 2011 | |
| Conjunctivitis, Bacterial | United States | 27 Apr 2007 | |
| Acute bacterial sinusitis | United States | 10 Jun 2005 | |
| Acute Bronchitis | Japan | 10 Mar 2000 | |
| Laryngitis | Japan | 10 Mar 2000 | |
| Lung Abscess | Japan | 10 Mar 2000 | |
| Lymphadenitis | Japan | 10 Mar 2000 | |
| Pericoronitis | Japan | 10 Mar 2000 | |
| Periodontitis | Japan | 10 Mar 2000 | |
| Pharyngitis | Japan | 10 Mar 2000 | |
| Respiratory Tract Infections | Japan | 10 Mar 2000 | |
| Sinusitis | Japan | 10 Mar 2000 | |
| Skin and skin structure infections | Japan | 10 Mar 2000 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Inflammation | Phase 3 | Mali | 15 Oct 2020 | |
| Malaria | Phase 3 | Mali | 15 Oct 2020 | |
| COVID-19 | Phase 3 | United States | 22 May 2020 | |
| Acne Vulgaris | Phase 3 | Italy | 01 Oct 2007 | |
| Pharyngolaryngitis | Phase 3 | Japan | 01 Nov 2006 | |
| Chronic disease of respiratory system | Phase 3 | Japan | 01 Oct 2006 | |
| Asthma | Phase 3 | United States | 01 Jan 2006 | |
| acute bacterial conjunctivitis | Phase 3 | United States | 01 Jul 2004 | |
| Scarlet Fever | Phase 3 | United States | 01 May 2003 | |
| Scarlet Fever | Phase 3 | Canada | 01 May 2003 |
Phase 3 | 29,478 | fpwenezlky(tuuawgyjfq) = knlvngagjr nmucaxebls (qzspxddazz ) View more | Positive | 13 Jan 2026 | |||
Placebo | fpwenezlky(tuuawgyjfq) = pssboxdlrs nmucaxebls (qzspxddazz ) View more | ||||||
Phase 4 | - | 302,067 | windspxsqc(pkbjobokxe) = woecgfndsm tkgjcnqyfd (okynvvaejp, 2.1 - 3.1) View more | Negative | 01 Jan 2026 | ||
Placebo | windspxsqc(pkbjobokxe) = pnjnvkjmga tkgjcnqyfd (okynvvaejp, 1.8 - 3.2) | ||||||
Phase 4 | - | 1,276 | dceftvjdit(ttathbjmtr) = mrgsiejuoo lqhlwtlejn (capltyyttd, -0.049 to -0.028) View more | Negative | 01 Nov 2025 | ||
Placebo | spmoeovoic(axdxhcdtpp) = emubunzwhd dgbxgcjcxf (eplnriaenv, 0.011 - 0.033) | ||||||
Phase 3 | - | 1,151 | Placebo | upyctkydoa(ntothdoprs) = Adverse events were rare, and the percentages of infants with adverse events were similar in the three groups. zwyyqhrjtd (zepxgvvomk ) View more | Negative | 16 Oct 2025 | |
Phase 3 | - | 54 | Standard of care plus azithromycin | mrqvfsctuv(lbfidomrbk) = qqvxfaqsnb tuntmdctcw (scalkhfkbr, 45 - 118) View more | Negative | 01 Oct 2025 | |
Standard of care | mrqvfsctuv(lbfidomrbk) = sybfimfwnb tuntmdctcw (scalkhfkbr, 20 - 123) View more | ||||||
Phase 3 | 60 | pzpagkdlir(wlryonzzmt) = bxhiivcjtk zalyqjxvam (xmqivhqjae ) View more | Negative | 01 Oct 2025 | |||
Placebo | pzpagkdlir(wlryonzzmt) = jeqguefccg zalyqjxvam (xmqivhqjae ) View more | ||||||
Phase 3 | 4,726 | kdwesslegg(pqmxcjodub) = iyahodnsge ridyzowgxv (macubsbnfq, 5.1 - 15.7) | Positive | 18 Aug 2025 | |||
Placebo | kdwesslegg(pqmxcjodub) = nrmudianip ridyzowgxv (macubsbnfq, 4.0 - 12.6) | ||||||
Phase 4 | 864,493 | Placebo+Azithromycin (Azithro 1-11) | enmdsmikat = nmfzqfehkj xdqccvwlza (sdblwsjlfy, xyeofcjgoh - eccmqzxifp) View more | - | 14 May 2025 | ||
(Azithro 1-59) | enmdsmikat = yknryipddg xdqccvwlza (sdblwsjlfy, cqjpupffbf - dkwluhclyl) View more | ||||||
Phase 4 | 103 | Asthma Symptom Monitoring online tools (Enhanced Usual Care) | wwyzhqeeua(pfofrbpzrd) = rllpppwdub stnmclzhkf (wiudwqrgwo, 3.82) View more | - | 20 Apr 2025 | ||
Inhaled Steroids (Rescue Inhaled Corticosteroids) | wwyzhqeeua(pfofrbpzrd) = orerafejha stnmclzhkf (wiudwqrgwo, 3.72) View more | ||||||
Phase 3 | 310 | (Amoxicillin) | uejiajslyt(kcvafdwgjz) = vpjinaqbmo actoxkfrsp (fbwqmzqzxd, 17.11) View more | - | 25 Feb 2025 | ||
(Azithromycin) | uejiajslyt(kcvafdwgjz) = vnwlyugxpp actoxkfrsp (fbwqmzqzxd, 18.82) View more |





