Amikin
(Amikacin)ApprovedSmall molecule
Amikacin is an antibiotic used to treat serious bacterial infections, particularly those caused by gram-negative bacteria and some gram-positive bacteria. It's often used for infections that don't respond to other antibiotics.[2] Amikin is currently approved and in use across 21 indications[4].[1]
Amikin is one of 296 small molecule programs targeting Bacterial Disease. It is currently in Approved.
21
Indications
29
Total Trials
6
Active Trials
295
Competitors
3
FDA Applications
NDA/BLA/ANDA regulatory filings
14
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 21 indications
Competition
Competitive Landscape
152 competitors in Pneumonia
#DrugCompanyPhaseTrials
1Amikin
IInsmed Incorporated
Approved
Jakafi
IncytePreclinical
Avlosulfon
AAlmirall, S.A.
Preclinical
Primsol
CConrado Roberto Hoffmann Filho
Preclinical
Advil
KKenvue Brands
Preclinical
Pepcid
KKenvue Brands
Preclinical
Aciphex
Akero TherapeuticsPreclinical
Protonix
WWyeth-Lederle Vaccines
Preclinical
Alka-Seltzer
AAbbott
Preclinical
Tylenol
KKenvue Brands
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Cystic Fibrosis3 trials
Pneumonia3 trials
Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation
Unknown status·AAssociation Pour La Promotion A Tours De La Reanimation Medicale·Phase 2/3·NCT00861315·24 enrolled
Abscess2 trials
Critically Ill Patients2 trials
Transurethral Resection1 trial
Antimicrobial Prophylaxis in Patients Who Underwent a Transurethral Resection of Bladder (TURB)
Completed·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 2·NCT04209192·75 enrolled
18 more indications
Hypothermia1 trial
Antibiotic Therapy1 trial
Pregnancy1 trial
Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled
Urinary Tract Infection1 trial
Potentiated Aminoglycosides in Postoperative Urinary Tract Infection Prophylaxis
Recruiting·—·Phase 1·NCT05761405·90 enrolled
Multidrug-Resistant Tuberculosis1 trial
Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis
Unknown status·—·Phase 2·NCT05555303·20 enrolled
Necrotizing Enterocolitis1 trial
the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy
Unknown status·—·Phase 1·NCT06097767·50 enrolled
Liver1 trial
Neutropenia1 trial
Local1 trial
Ventilator-Associated Pneumonia1 trial
Urinary Tract Infections1 trial
Pneumonia, Bacterial1 trial
Regulatory
FDA Approval Timeline[5]
Jan 1, 1982
AMIKIN
NDA NDA050495
Nov 30, 1987
AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA NDA050618
Sep 28, 2018
ARIKAYCE KIT
NDA NDA207356
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Amikin drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Amikacin. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Amikin. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Bacterial 70s Ribosome Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- IInsmed Incorporated