Drugs / Paromomycin
Paromomycin
also known as
Paromomycin Sulfate · Aminosidin · aminosidine · Aminoxidin · ANTIBIOTIC 503-3 · ANTIBIOTIC SF 767B · Catenulin · Crestomycin · +28 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | HUMATIN | — | 1969-03-24 | fda.gov ↗ |
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01050777 | Mar 2011 → Jan 2012 | cutaneous leishmaniasis | Tehran University of Medical Sciences | Completed | No outcome recorded |
| Phase 29 trials · 1 met primary | ||||||
| Phase 2 | NCT03399955 | May 2018 → May 2021 | cutaneous leishmaniasis | Drugs for Neglected Diseases | Unknown | No outcome recorded |
| Phase 2 | NCT01988909 | Sep 2013 → Dec 2015 | cutaneous leishmaniasis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT01140191 | Sep → Dec 2013 | cutaneous leishmaniasis | U.S. Army Medical Research and Development Command | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01494350 | Dec 2011 → Jun 2012 | cutaneous leishmaniasis | U.S. Army Medical Research and Development Command | Terminated | No outcome recorded |
| Phase 2 | NCT02366884 | Jul 2011 → Dec 2022 | neoplasm | Dr. Frank Arguello Cancer Clinic | Unknown | No outcome recorded |
| Phase 2 | NCT00657917 | Dec 2006 → Jun 2007 | cutaneous leishmaniasis | U.S. Army Medical Research and Development Command | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01536795 | Oct 2005 → Feb 2007 | cutaneous leishmaniasis | U.S. Army Medical Research and Development Command | Completed | No outcome recorded |
| Phase 2 | NCT00703924 | Mar 2003 → Nov 2004 | cutaneous leishmaniasis | U.S. Army Medical Research and Development Command | Completed | Met primary |
| Phase 2 | NCT00000771 | ? → Sep 1996 | HIV infectious disease, cryptosporidiosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03829917 | Feb 2019 → Dec 2020 | cutaneous leishmaniasis | Fundacion Nacional de Dermatologia | Completed | No outcome recorded |
| Phase 2/3 | NCT03096457 | Apr 2017 → Mar 2018 | cutaneous leishmaniasis | Fundacion Nacional de Dermatologia | Completed | No outcome recorded |
| Phase 39 trials · 4 met primary · 1 missed | ||||||
| Phase 3 | NCT03129646 | Jan 2018 → Dec 2020 | visceral leishmaniasis | Drugs for Neglected Diseases | Completed | Missed primary |
| Phase 3 | NCT01790659 | May 2013 → Jan 2016 | cutaneous leishmaniasis | U.S. Army Medical Research and Development Command | Completed | No outcome recorded |
| Phase 3 | NCT01122771 | May 2010 → Mar 2014 | visceral leishmaniasis | Drugs for Neglected Diseases | Completed | Met primary |
| Phase 3 | NCT00696969 | Jun 2008 → Jan 2010 | visceral leishmaniasis | Drugs for Neglected Diseases | Completed | Met primary |
| Phase 3 | NCT00629031 | Feb 2008 | visceral leishmaniasis | Banaras Hindu University | Completed | No outcome recorded |
| Phase 3 | NCT00606580 | Jan 2008 → Jul 2011 | cutaneous leishmaniasis | U.S. Army Medical Research and Development Command | Completed | Met primary |
| Phase 3 | NCT00523965 | Sep 2007 → Aug 2009 | visceral leishmaniasis | Banaras Hindu University | Completed | No outcome recorded |
| Phase 3 | NCT00255567 | Nov 2004 → Jan 2010 | visceral leishmaniasis | Drugs for Neglected Diseases | Completed | Mixed |
| Phase 3 | NCT00216346 | Jun 2003 → Nov 2004 | visceral leishmaniasis | PATH | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT00604955 | Oct 2007 → Dec 2008 | visceral leishmaniasis | PATH | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06907498 | Jan 2024 → Jun 2026 overdue | dientamoebiasis | Sheba Medical Center | Recruiting | No outcome recorded |
| — | NCT01780909 | Feb → Dec 2013 | — | KU Leuven | Unknown | No outcome recorded |
| — | NCT01328457 | Jan → May 2011 | visceral leishmaniasis | PATH | Completed | No outcome recorded |
| — | NCT00490230 | Apr → Jun 2007 | cutaneous leishmaniasis | U.S. Army Medical Research and Development Command | Completed | No outcome recorded |
| — | NCT00004444 | Nov 1994 → Jan 2001 | pulmonary tuberculosis | FDA Office of Orphan Products Development | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01641796 | — | cutaneous leishmaniasis | U.S. Army Medical Research and Development Command | No longer available | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05957978 Comparator | Mar 2024 → Jun 2025 | visceral leishmaniasis | Drugs for Neglected Diseases | Completed | 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 3 | NCT07463040 Comparator | Jan 2027 → Mar 2029 expected | cutaneous leishmaniasis | Institute of Tropical Medicine, Belgium | Not yet recruiting | No outcome recorded |
| — | NCT00001128 Background | ? → Jun 2005 | HIV infectious disease, cryptosporidiosis | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-07-29 | Drugs for Neglected Diseases | Results WHO recommends new, better and safer treatment regimens for leishmaniasis dndi.org ↗
The MF+PM regimen demonstrated over 90% effectiveness and reduces treatment from 34 painful injections over 17 days to 14 injections over 14 days – 20 fewer injections – with one injection per day alongside oral MF. |
| 2024-07-17 | Drugs for Neglected Diseases | Results Clinical trial in Eastern Africa finds a shorter, safer, and more effective treatment for PKDL, a stigmatizing skin disease dndi.org ↗
At the 12-month follow-up visit, 98% of the participants had achieved a complete cure, including those with moderate and mild PKDL. |
| 2022-09-29 | Drugs for Neglected Diseases | Results Better, shorter combination treatment for people with visceral leishmaniasis shown to be effective in Eastern Africa dndi.org ↗
A shorter, and less toxic treatment for people with visceral leishmaniasis was shown to be effective thanks to a study conducted in Eastern Africa by the non-profit medical research organization Drugs for Neglected Diseases initiative (DNDi) and its partners. |
| 2014-10-14 | Drugs for Neglected Diseases | Results Study Results Support WHO Recommendations for Safe and Effective Kala-azar Treatments in Bangladesh | DNDi dndi.org ↗
The combination treatments (AmBisome® + miltefosine; AmBisome® + paromomycin; paromomycin + miltefosine) were non-inferior to AmBisome® monotherapy: the combinations of AmBisome® + paromomycin and paromomycin + miltefosine demonstrated excellent cure rates of above 98%, thus comparable with AmBisome® monotherapy. |
| 2014-09-30 | Drugs for Neglected Diseases | Results Results of Large-Scale Roll Out of Combination Treatment for Kala-Azar in Eastern Africa Points to Urgency to Treat Disease Victims as Outbreak Surges in South Sudan | DNDi dndi.org ↗
In this large cohort of patients, treated under normal field conditions, the results confirmed the safety and high rate of efficacy of the combination treatment in the fight against this fatal neglected tropical disease. |
| 2011-01-24 | Drugs for Neglected Diseases | Results Study shows the safety and efficacy of combination treatment for visceral leishmaniasis in India | DNDi dndi.org ↗
A phase III clinical trial study published online in The Lancet shows that three short-course combination treatments for visceral leishmaniasis in India are efficacious and safe. |
All press releases naming this drug 7 releases
Evidence & citations 39 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Paromomycin | “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 ↗30“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 ↗ “The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.” NCT00606580 ↗ “The active ingredients of WR279396 are two aminoglycosides - paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC).” NCT01536795 ↗ “Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days” NCT01140191 ↗ “WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin” NCT00703924 ↗ “Paromomycin + Gentamicin Topical Cream” NCT01988909 ↗ “Paromomycin” NCT02099240 ↗ |
| Known as | Aminosidin | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | aminosidine | “Pilot Randomized Study of Paromomycin (Aminosidine) vs Streptomycin for Uncomplicated Pulmonary Tuberculosis” NCT00004444 ↗ |
| Known as | Aminoxidin | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | ANTIBIOTIC 503-3 | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | ANTIBIOTIC SF 767B | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Catenulin | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Crestomycin | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Estomycin | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Farmiglucin | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Farminosidin | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Gabbromicina | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Gabbromycin | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Gabbroral | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Gabromycin | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Humagel | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Humatin | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Hydroxymycin | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Monomycin a | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Neomycin e | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | NSC-758421 | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Paramicina | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Paramomycin | “Doxycycline, Paramomycin, Clarithromycin, Clindamycin, Dapsone, Miltefosine” NCT02366884 ↗ |
| Known as | Pargonyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Paricina | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Paromomicina | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Paromomycin i | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Paromomycin Intramuscular Injection | “support registration of Paromomycin Intramuscular Injection (PMIM) as a low-cost treatment option in Bangladesh.” PMID 26496648 ↗ Oct 2015 |
| Known as | Paromomycin Sulfate | “Drug: Paromomycin Sulfate” NCT03096457 ↗ |
| Known as | Paromomycin sulphate | “Paromomycin sulphate (PM) has been shown to be efficacious for VL treatment in India.” PMID 22724029 ↗ Jun 2012 |
| Known as | Paromomycin-in-Aquaphilic | “Paromomycin-in-Aquaphilic had a cure rate of 77.5% (31 of 40 patients)” NCT03829917 ↗ |
| Known as | Paromomycine | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Paucimycin | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | PMIM | “support registration of Paromomycin Intramuscular Injection (PMIM) as a low-cost treatment option in Bangladesh.” PMID 26496648 ↗ Oct 2015 |
| Known as | Quintomycin c | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | R 400 | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Known as | Sinosid | ChEMBL registry synonym — accepted as the source's own label CHEMBL370143 ↗ |
| Modality | Small molecule | “paromomycin, an aminoglycoside” PMID 17582067 ↗ Jun 2007 |
| Route | Oral | “effectiveness of oral paromomycin sulfate” NCT00000771 ↗ |