Gentamicin
Small molecule targets CFTR via restoration
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | GARAMYCIN | — | 1966-03-15 | fda.gov ↗ |
Trials 120 · started per year
Also used as a comparator or background therapy in 66 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT03213249 Comparator | Jul 2017 → Sep 2018 | breast disorder | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT06428448 Background | Feb 2026 → Aug 2027 expected | periprosthetic joint infection | OsteoRemedies, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT05702762 Comparator | Oct 2022 → Jun 2023 | cystitis | Mercy Health Ohio | Unknown | No outcome recorded |
| Phase 2 | NCT04246996 Comparator | Jan 2020 → Dec 2021 | female stress incontinence, pelvic organ prolapse, urinary tract infection | Kaiser Permanente | Completed | No outcome recorded |
| Phase 2 | NCT03492866 Comparator | Apr 2018 → Feb 2019 | hypotrichosis simplex | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT03453177 Background | Mar 2018 → Mar 2019 | neonatal sepsis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 2 | NCT02735317 Comparator | Apr 2016 → Jun 2017 | nasopharyngeal neoplasm, stomatitis | Yun-fei Xia | Unknown | No outcome recorded |
| Phase 2 | NCT01083576 Comparator | Mar 2010 → Jun 2011 | cutaneous leishmaniasis | U.S. Army Medical Research and Development Command | Completed | No outcome recorded |
| Phase 2 | NCT01032382 Comparator | Jan 2010 → Mar 2011 | cutaneous leishmaniasis | U.S. Army Medical Research and Development Command | Completed | No outcome recorded |
| Phase 2/38 trials | ||||||
| Phase 2/3 | NCT05051163 Comparator | Jun 2021 → Jun 2024 | HIV infectious disease, protein-energy malnutrition | Makerere University | Unknown | No outcome recorded |
| Phase 2/3 | NCT03622450 Comparator | Jan 2016 → Jan 2018 | — | Nourhan Hassan Osama Thuraya Mohamed | Completed | No outcome recorded |
| Phase 2/3 | NCT01931592 Comparator | Jan 2014 → Oct 2016 | cancer | Maria J.G.T. Vehreschild | Terminated | No outcome recorded |
| Phase 2/3 | NCT01994993 Comparator | Dec 2013 → Jan 2017 | — | Michael Cohen-Wolkowiez | Completed | No outcome recorded |
| Phase 2/3 | NCT00879190 Comparator | May 2009 → Jun 2012 | chorioamnionitis | Stanford University | Completed | No outcome recorded |
| Phase 2/3 | NCT00802529 Comparator | Apr 2009 → May 2015 | Meniere disease | Imperial College London | Completed | No outcome recorded |
| Phase 2/3 | NCT01633294 Comparator | Oct 2008 → Jan 2011 | chorioamnionitis, endometritis, infectious meningitis, neonatal sepsis | Hospital de Santa Maria, Portugal | Completed | No outcome recorded |
| Phase 2/3 | NCT01244256 Background | Apr → Aug 2007 | folliculitis | Azidus Brasil | Suspended | No outcome recorded |
| Phase 313 trials | ||||||
| Phase 3 | NCT07107477 Comparator | May 2025 → Sep 2027 expected | preterm premature rupture of the membranes | The Central and Eastern European Gynecologic Oncology Group | Recruiting | No outcome recorded |
| Phase 3 | NCT05977400 Comparator | Apr 2024 → Mar 2029 expected | neurodevelopmental disorder | Sharp HealthCare | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06489431 Comparator | Dec 2023 → May 2026 overdue | erectile dysfunction, prosthesis-related infectious disease | Rush University Medical Center | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05658874 Background | Dec 2022 → Dec 2024 | interstitial cystitis, levator syndrome | Jocelyn Fitzgerald | Terminated | No outcome recorded |
| Phase 3 | NCT05594472 Comparator | Nov 2022 → Apr 2023 | bullous pemphigoid, pemphigus vulgaris | Cairo University | Unknown | No outcome recorded |
| Phase 3 | NCT05429671 Comparator | Jun 2022 → Nov 2023 | — | Rothman Institute Orthopaedics | Completed | No outcome recorded |
| Phase 3 | NCT05164081 Background | Jan 2022 → Jan 2026 overdue | periprosthetic joint infection | Umeå University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03174236 Comparator | Sep 2017 → Jan 2020 | poisoning, protein-energy malnutrition | University of Oxford | Unknown | No outcome recorded |
| Phase 3 | NCT02717871 Comparator | Mar 2016 → Oct 2020 | keratitis | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 3 | NCT02579161 Comparator | Sep 2014 → Mar 2018 | urolithiasis | Northwell Health | Completed | No outcome recorded |
| Phase 3 | NCT01551394 Comparator | Sep 2012 → Dec 2014 | infectious disease with sepsis | PENTA Foundation | Completed | No outcome recorded |
| Phase 3 | NCT01429701 Comparator | May → Jun 2012 | dermatitis | EMS | Completed | No outcome recorded |
| Phase 3 | NCT01027429 Comparator | Dec 2009 → Dec 2013 | neonatal sepsis | Aga Khan University | Completed | No outcome recorded |
| Phase 417 trials | ||||||
| Phase 4 | NCT06712641 Comparator | Apr 2026 → Jun 2028 expected | infectious disease with sepsis | University Hospital, Akershus | Recruiting | No outcome recorded |
| Phase 4 | NCT07236944 Comparator | Dec 2025 → Mar 2029 expected | bacterial urinary tract infection | Uppsala University | Recruiting | No outcome recorded |
| Phase 4 | NCT06814223 Comparator | Oct 2024 → Dec 2027 expected | prosthesis-related infectious disease | Western Galilee Hospital-Nahariya | Recruiting | No outcome recorded |
| Phase 4 | NCT05971537 Comparator | Jun 2023 → Oct 2026 expected | infectious peritonitis | Alice Ho Miu Ling Nethersole Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05421741 Comparator | May 2023 → Dec 2026 expected | osteomyelitis | Wake Forest University Health Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT04285320 Comparator | Mar 2021 → Apr 2023 | urinary tract infection | Atlantic Health System | Unknown | No outcome recorded |
| Phase 4 | NCT03997266 Comparator | Aug 2020 → Jan 2026 | neonatal sepsis, perinatal necrotizing enterocolitis | Michael Morowitz | Completed | No outcome recorded |
| Phase 4 | NCT03560232 Comparator | Jul 2018 → Feb 2020 | — | Mercy Health Ohio | Terminated | No outcome recorded |
| Phase 4 | NCT03299387 Comparator | Jun 2017 → Jul 2018 | urinary tract infection | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 4 | NCT02582099 Comparator | Jan 2017 → Jun 2019 | sinusitis | Mahidol University | Unknown | No outcome recorded |
| Phase 4 | NCT03007225 Comparator | Jul 2015 → Aug 2016 | hepatocellular carcinoma | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT02384200 Background | Mar 2015 → Feb 2017 | nephrolithiasis, urinary tract infection | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT02309346 Background | Dec 2014 → Dec 2023 | uterine disorder | Hospital de Clinicas de Porto Alegre | Completed | No outcome recorded |
| Phase 4 | NCT01659866 Comparator | Aug 2012 → Aug 2015 | infectious disease | Northwestern University | Completed | No outcome recorded |
| Phase 4 | NCT01273818 Comparator | Jan 2011 → Feb 2013 | — | Diskapi Teaching and Research Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00749866 Comparator | May 2007 → Aug 2009 | bronchiectasis | University of Edinburgh | Completed | No outcome recorded |
| Phase 4 | NCT00571259 Comparator | Sep 2003 → Jan 2010 | bacterial infectious disease | Satellite Healthcare | Completed | No outcome recorded |
| Phase not applicable18 trials | ||||||
| — | NCT06168708 Comparator | Dec 2023 → Jun 2024 | — | Tanta University | Unknown | No outcome recorded |
| — | NCT05469984 Comparator | Nov 2022 → Sep 2025 overdue | preterm premature rupture of the membranes | Western Galilee Hospital-Nahariya | Recruiting | No outcome recorded |
| — | NCT05143164 Comparator | Mar 2022 → Jul 2025 | — | Singapore General Hospital | Completed | No outcome recorded |
| — | NCT04438655 Background | May 2019 → Nov 2021 | — | University of Turin, Italy | Completed | No outcome recorded |
| — | NCT02865564 Comparator | Nov 2016 → Mar 2020 | digestive system disorder | University Medical Centre Ljubljana | Completed | No outcome recorded |
| — | NCT02829060 Comparator | Jan 2016 → Jan 2025 | infectious disease with sepsis, nephrolithiasis, urinary tract infection | University of California, San Diego | Completed | No outcome recorded |
| — | NCT02395614 Comparator | Dec 2015 → Dec 2020 | breast cancer | Vanderbilt University Medical Center | Completed | No outcome recorded |
| — | NCT02477423 Comparator | Jul 2015 → Jun 2019 | perinatal necrotizing enterocolitis, pulmonary immaturity | University of Chicago | Completed | No outcome recorded |
| — | NCT02288923 Comparator | Mar 2015 → Jul 2018 | osteoarthritis, knee | Royal Devon and Exeter NHS Foundation Trust | Completed | No outcome recorded |
| — | NCT01945450 Comparator | Jan 2014 → Sep 2016 | endometritis | Hadassah Medical Organization | Unknown | No outcome recorded |
| — | NCT01372371 Comparator | Jun 2011 → Jun 2012 | infectious disease | Ganga Hospital | Unknown | No outcome recorded |
| — | NCT01148693 Comparator | Dec 2009 → Dec 2010 | cholangitis | Tehran University of Medical Sciences | Completed | No outcome recorded |
| — | NCT01266499 Comparator | Jul 2009 → Jan 2011 | Klebsiella infectious disease | Rambam Health Care Campus | Completed | No outcome recorded |
| — | NCT00844337 Comparator | Mar 2009 → Sep 2013 | infectious disease with sepsis | Johns Hopkins Bloomberg School of Public Health | Completed | No outcome recorded |
| — | NCT00814905 Comparator | Nov 2008 → Jan 2012 | chorioamnionitis | United States Naval Medical Center, Portsmouth | Withdrawn | No outcome recorded |
| — | NCT00753558 Comparator | Nov 2008 → Jun 2010 | — | Soroka University Medical Center | Completed | No outcome recorded |
| — | NCT00484055 Comparator | Jan 2007 → Aug 2008 | drug-resistant tuberculosis, periprosthetic joint infection | Region Örebro County | Completed | No outcome recorded |
| — | NCT00185991 Comparator | Jun 2004 → Oct 2006 | chorioamnionitis | Stanford University | Completed | No outcome recorded |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 187 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gentamicin | “Each subject will receive a single dose of 15 mg/kg vancomycin; 2 mg/kg gentamicin and 250 mg levofloxacin administered intravenously over a one-hour infusion period through...” NCT00596167 ↗163“Some commonly used antibiotics for the treatment of PD peritonitis with their suggested concentrations in the antibiotic-lock are quoted as below: Cefazolin 10mg/mL...” NCT05971537 ↗ “Assessment of Cutaneous Leishmaniasis Scar (Caused by Leishmania Major) for Cosmetic Outcome After Treatment With WR279396 (Paromomycin/Gentamicin Cream in Vehicle) Versus a No...” NCT00490230 ↗ “A sample of 802 ELBW preterm infants will undergo web-based stratified block randomization to receive empiric antibiotics (EA; ampicillin and gentamicin) or placebo during...” PMID 35606829 ↗ May 2022 “Antibiotics: Ceftazidime-Avibactam or Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline-Gentamicin, Tigecycline-Meropenem or...” NCT05862402 ↗ “Participants were randomly assigned into two groups: a standard root canal treatment group (n = 40) and an adjunctive treatment group receiving submucosal betamethasone and...” NCT07704398 ↗ “WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and...” NCT01494350 ↗ “OBJECTIVE: To evaluate the efficacy of intraocular gentamicin sulfate and clindamycin in the prevention of acute posttraumatic bacterial endophthalmitis following penetrating...” PMID 17420365 ↗ Apr 2007 “WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a steril” NCT00606580 ↗ “Prevention of tunneled hemodialysis catheter-related infections using catheter-restricted filling with gentamicin and citrate: a randomized controlled study.” PMID 12138146 ↗ Aug 2002 “ampicillin 50mg/kg twice daily and gentamicin \[3mg/kg for babies \<2kg or 5mg/kg for babies \>2kg\] once daily for 7 days, as per Kenyan guidelines).” NCT03453177 ↗ “Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting.” NCT01585129 ↗ “As previous studies have shown promising results for a combination of colistin and gentamicin, the latter was added to the eradication regimen.” NCT01931592 ↗ “The active ingredients of WR279396 are two aminoglycosides - paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC).” NCT01536795 ↗ “The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole” NCT03303677 ↗ “Gentamicin 5 mg/kg IV (\<60 kg 240 mg, 61-80 kg 320 mg, \>80 kg 400 mg) every 24h for 5-7 days according to the clinical state.” NCT07107477 ↗ “Antibiotic prophylaxis is as per the hospital protocol (currently 6mg/kg Teicoplanin IV and 3mg/kg gentamicin pre induction).” NCT02288923 ↗ “broad-spectrum prophylaxis of a combined single-shot of vancomycin 1 g and gentamicin 5 mg/kg parenterally” PMID 38243311 ↗ Jan 2024 “Dudley described the use of topical gentamicin in a case report of a patient with atrophic rhinitis.” NCT00669799 ↗ “The first 10 patients will be treated with the PWD + gentamicin and will serve as a safety subset.” NCT04753723 ↗ “Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days” NCT01140191 ↗ “delivers a consistent dose of fast-release antibiotics called Gentamicin Sulphate (2.0 mg/cm2).” NCT01667874 ↗ “standard chemoprophylaxis plus gentamicin 160mg intramuscular once just before the biopsy” NCT02423759 ↗ “The PMMA of the REMEDY SPECTRUM IM Spacer Nail is laden with gentamicin and vancomycin.” NCT06428448 ↗ “intraperitoneal irrigation with clindamycin (600mg) and gentamicin (240 mg) solution” NCT03081962 ↗ “antibiotic irrigation using gentamicin, clindamycin and suction during the surgery” NCT04039750 ↗ “WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin” NCT00703924 ↗ “WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%” NCT01790659 ↗ “Intravesical lidocaine, heparin, sodium bicarb, Kenalog, gentamicin” NCT05658874 ↗ “tienam,meropenem,levofloxacin,ciprofloxacin,amikacin,gentamicin” NCT03622450 ↗ “antibiotic powder (Vancomycin 2gm) and 560mg gentamicin liquid.” NCT05421741 ↗ “aminoglycosides; amikacin, gentamicin, tobramycin, 6) other” NCT07236944 ↗ “The first vial of SF will contain 240 mg of gentamicin.” NCT02309346 ↗ “Paromomycin + Gentamicin Topical Cream” NCT01988909 ↗ “Ampicillin or Gentamicin or Cefotaxime” NCT02784821 ↗ “80 mg of gentamicin in 500 mL of NS.” NCT02395614 ↗ “Gentamicin 7 mg/kg once daily” NCT01356641 ↗ “Gentamycin-Gentamicin®” NCT02033408 ↗ “* Gentamicin 80 mg” NCT00317070 ↗ “Gentamicin” NCT02099240 ↗ |
| Known as | AppliGel-G | “AppliGel-G is a topically applied hydrogel formulation of gentamicin sulfate (GMS).” NCT02036528 ↗ |
| Known as | Garamycin | “Gentamicin, Garamycin” NCT04140786 ↗ |
| Known as | Garamycin Sponge | “Garamycin Sponge (Gentamicin-Collagen sponge)” NCT01951768 ↗ |
| Known as | Gentamicin (gentamicin) | “Gentamicin (gentamicin)” NCT00596167 ↗ |
| Known as | Gentamicin Sulfate | “containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)” NCT01951768 ↗11“AppliGel-G is a topically applied hydrogel formulation of gentamicin sulfate (GMS).” NCT02036528 ↗ “Gentamicin Sulfate Inj 20mg/2ml vial for injection” NCT03476941 ↗ “Gentamicin Sulfate, Topical” NCT05143164 ↗ “Drug: Gentamicin Sulfate” NCT03012191 ↗ |
| Known as | Gentamicin Sulphate | “delivers a consistent dose of fast-release antibiotics called Gentamicin Sulphate (2.0 mg/cm2).” NCT01667874 ↗ |
| Known as | Gentamicin topical gel | “The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to...” NCT02036528 ↗ |
| Known as | Gentamicin, Garamycin | “Gentamicin, Garamycin” NCT03012191 ↗ |
| Known as | gentamicin-collagen sponge | “The gentamicin-collagen sponge, a surgically implantable topical antibiotic, is currently approved in 54 countries.” PMID 20716738 ↗ Aug 20101“Garamycin Sponge (Gentamicin-Collagen sponge)” NCT01951768 ↗ |
| Known as | Gentamicins | “Drug: Gentamicins” NCT02379754 ↗ |
| Known as | gentamycin | “The aim of this study is to investigate whether topical aminoglycosides (Gentamycin) may be beneficial for the treatment of HHS patients carrying nonsense mutations by inducing...” NCT03492866 ↗16“mLDG (lidocaine 0.16mg/mL, dexamethasone 0.02mg/mL, and gentamycin 0.16mg/mL) dissolved in 0.9% saline solution was administered three times a day.” NCT02577393 ↗ “Patients with known allergy to one of the drugs may be treated with oral Gentamycin (2.5mg/KgX3/d) for 3 weeks instead of the allergenic drug.” NCT02033408 ↗ “Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day until clinical improvement” NCT02309346 ↗ “an impirical antibiotic (gentamycin 80 mg).” NCT03007225 ↗ “Clindamycin 600 mg + Gentamycin 2 mg/kg.” NCT04438655 ↗ “Gentamycin-80mg in 60ml sterile water” NCT04285320 ↗ |
| Known as | Gentamycin-Gentamicin | “Gentamycin-Gentamicin®” NCT02033408 ↗ |
| Known as | GMS | “AppliGel-G is a topically applied hydrogel formulation of gentamicin sulfate (GMS).” NCT02036528 ↗ |
| Known as | Hexamycin | “gentamycin 40 mg ("Hexamycin®"), solution” NCT03157388 ↗1“gentamycin 40 mg ("Hexamycin®")” NCT01633762 ↗ |
| Action | Restore | “gentamicin was shown to restore functional dystrophin in a mouse model of DMD.” NCT00005574 ↗ |
| Modality | Small molecule | “aminoglycoside antibiotics (gentamicin)” NCT00484055 ↗ |
| Route | Intravenous | “Gentamicin will be given intravenously (through a vein) once a day for 14 days.” NCT00005574 ↗ |
| Target | CFTR | “Suppression of stop mutations in the CFTR gene with parenteral gentamicin” NCT00376428 ↗ |