neomycin
Approved
Apr 19, 1954
Neomycin is an aminoglycoside antibiotic found in many topical medications such as creams, ointments, and eye drops. In vitro tests have demonstrated that neomycin is bactericidal and acts by inhibiting the synthesis of protein in susceptible bacterial cells. It is effective primarily against gram-negative bacilli but does have some activity against gram-positive organisms. Neomycin is active in vitro against Escherichia coli and the Klebsiella-Entero. Topical uses include treatment for superficial eye infections caused by susceptible bacteria (used in combination with other anti-infective), treatment of otitis externa caused by susceptible bacteria, treatment or prevention of bacterial infections in skin lesions, and use as a continuous short-term irrigant or rinse to prevent bacteriuria and gram negative rod bacteremia in bacteriuria patients with indwelling catheters. May be used orally to treat hepatic encephalopathy, as a perioperative prophylactic agent, and as an adjunct to fluid and electrolyte replacement in the treatment of diarrhea caused to enter pathogenic E. coli (EPEC). Neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin Sulfate Oral Solution and other antibacterial drugs, susceptible bacteria should use Neomycin Sulfate Oral Solution only to treat or prevent infections that are proven or strongly suspected to be caused. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Neomycin binds to four nucleotides of 16S rRNA and a single amino acid of protein S12. This interferes with decoding site near nucleotide 1400 in 16S rRNA of 30S subunit. This region interacts with the wobble base in the anticodon of tRNA. This leads to interference with the initiation complex, misreading of mRNA so incorrect amino acids are inserted into the polypeptide leading to nonfunctional or toxic peptides and the breakup of polysomes into nonfunctional monosomes — NCATS
Clinical trial activity
46 trials · 66 clinical orgs · 41 marketing orgs
Earliest trial started Dec 1, 2003 (NCT00166868)
Timeline
1950s
- Apr 19, 1954
Earliest FDA Approval
- Apr 19, 1954
Dow Pharmaceutical Sciences — Marketing Organization
- Mar 26, 1957
Monarch Pharmaceuticals — Marketing Organization
- Mar 26, 1957
Monarch Pharmaceuticals — NDA Secondary Org
1960s
- May 17, 1962
Endo Pharmaceuticals — Marketing Organization
- May 17, 1962
Endo Pharmaceuticals — NDA Secondary Org
- May 10, 1963
Allergan — Marketing Organization
- May 10, 1963
Allergan — NDA Secondary Org
- Jun 6, 1963
Alcon — NDA Secondary Org
- Jun 6, 1963
Harrow Health — NDA Secondary Org
- Jun 11, 1963
Medimetriks — Marketing Organization
- Jul 19, 1963
Novartis — NDA Secondary Org
- Sep 2, 1964
Teva — Marketing Organization
- Oct 19, 1964
Bayer — Marketing Organization
- Oct 19, 1964
Bayer — NDA Secondary Org
- Dec 7, 1964
Pharmacia & Upjohn — NDA Secondary Org
- Dec 7, 1964
Pharmacia & Upjohn — Marketing Organization
- Oct 26, 1966
Lannett Company, Inc. — Marketing Organization
- Oct 26, 1968
Akorn, Inc. — Marketing Organization
- Oct 26, 1968
Epic Pharma Llc — Marketing Organization
- Jul 2, 1969
Merck — Marketing Organization
- Jul 2, 1969
Merck — NDA Secondary Org
1970s
- May 10, 1971
Casper Pharma LLC — Marketing Organization
- May 10, 1971
Casper Pharma LLC — NDA Secondary Org
- Jan 5, 1972
X Gen Pharmaceuticals — Marketing Organization
- Mar 12, 1974
Alcon — Marketing Organization
1980s
- Jan 22, 1981
Perrigo — Marketing Organization
- Jan 22, 1981
Padagis Us — Marketing Organization
- Aug 25, 1983
Sandoz — Marketing Organization
- Oct 29, 1984
Novartis — Marketing Organization
- Nov 30, 1984
Nestle — Marketing Organization
- Apr 8, 1986
Watson Pharmaceuticals — Marketing Organization
1990s
- Jul 25, 1994
Bausch & Lomb — Marketing Organization
2000s
- Oct 28, 2005
Amring Pharmaceticals — Marketing Organization
- Jan 1, 2007
Earliest Phase 3 Sponsor(trial)
- Mar 13, 2009
Pfizer — NDA Secondary Org
2010s
- Mar 29, 2010
Esteve Labs — Marketing Organization
- Mar 29, 2010
Nostrum Laboratories — Marketing Organization
- Jan 1, 2013
- Jan 1, 2013
Earliest Phase 2 Sponsor(trial)
- Jun 10, 2016
Chartwell Pharmaceuticals — Marketing Organization
Indications
Studied for
- Alopecia · Early Phase 1
- Alopecia Areata · Early Phase 1
- Anastomotic Leak · Phase 2
- Asymptomatic Infections · Phase 4
- Bacteremia · Phase 2/Phase 3
- Bronchiectasis · Phase 4
- Cataract · Phase 3
- Cataract Extraction · Phase 3
- Catheter-Related Infections · Phase 2/Phase 3
- Colitis, Ulcerative · Phase 1
- Colorectal Neoplasms · Phase 4
- Colorectal Surgery · Phase 4
- Conjunctivitis, Bacterial · Phase 3
- COVID-19 · Phase 1
- Crohn Disease · Phase 2
- Diverticulitis · Early Phase 1
- Drug Evaluation · Phase 3
- General Surgery · Phase 4
- Hemodialysis, Home · Phase 2/Phase 3
- Hordeolum · Phase 3
- Hypersensitivity · Phase 4
- Inflammatory Bowel Diseases · Early Phase 1
- Intestinal Neoplasms · Phase 2
- Neoplasms · Phase 1
- Otitis · Phase 3
- Pneumonia, Ventilator-Associated · Phase 2/Phase 3
- Prediabetic State · Phase 2
- Pseudomonas Infections · Phase 4
- Rabies · Phase 4
- Rectal Neoplasms · Phase 4
- Retinoblastoma · Phase 1
- Surgical Wound Infection · Phase 4
- Ulcer · Phase 3
- Urinary Tract Infections · Phase 4
- Vaccines · Phase 4
- Vaginitis · Phase 4
Mechanism of action
- 30S ribosomal protein S12ANTAGONIST
rpsL antagonist
- Bacterial 70S ribosomeINHIBITOR
Bacterial 70S ribosome inhibitor
30S,16S RNA
- 30S ribosomal protein S2 (rpsB) ↗
- 50S ribosomal protein L4 (rplD) ↗
- 30S ribosomal protein S15 (rpsO) ↗
- 30S ribosomal protein S16 (rpsP) ↗
- 30S ribosomal protein S17 (rpsQ) ↗
- 30S ribosomal protein S18 (rpsR) ↗
- 30S ribosomal protein S19 (rpsS) ↗
- 30S ribosomal protein S20 (rpsT) ↗
- 30S ribosomal protein S21 (rpsU) ↗
- 30S ribosomal protein S3 (rpsC) ↗
- 30S ribosomal protein S4 (rpsD) ↗
- 30S ribosomal protein S5 (rpsE) ↗
- 30S ribosomal protein S6 (rpsF) ↗
- 30S ribosomal protein S7 (rpsG) ↗
- 30S ribosomal protein S8 (rpsH) ↗
- 30S ribosomal protein S9 (rpsI) ↗
- 50S ribosomal protein L35 (rpmI) ↗
- 50S ribosomal protein L36 2 (ykgO) ↗
- 50S ribosomal protein L36 (rpmJ) ↗
- 50S ribosomal protein L3 (rplC) ↗
- 50S ribosomal protein L5 (rplE) ↗
- 50S ribosomal protein L6 (rplF) ↗
- 50S ribosomal protein L7/L12 (rplL) ↗
- 30S ribosomal protein S1 (rpsA) ↗
- 30S ribosomal protein S10 (rpsJ) ↗
- 30S ribosomal protein S11 (rpsK) ↗
- 30S ribosomal protein S12 (rpsL) ↗
- 30S ribosomal protein S13 (rpsM) ↗
- 30S ribosomal protein S14 (rpsN) ↗
- 50S ribosomal protein L10 (rplJ) ↗
- 50S ribosomal protein L11 (rplK) ↗
- 50S ribosomal protein L13 (rplM) ↗
- 50S ribosomal protein L14 (rplN) ↗
- 50S ribosomal protein L15 (rplO) ↗
- 50S ribosomal protein L16 (rplP) ↗
- 50S ribosomal protein L17 (rplQ) ↗
- 50S ribosomal protein L18 (rplR) ↗
- 50S ribosomal protein L19 (rplS) ↗
- 50S ribosomal protein L1 (rplA) ↗
- 50S ribosomal protein L20 (rplT) ↗
- 50S ribosomal protein L21 (rplU) ↗
- 50S ribosomal protein L22 (rplV) ↗
- 50S ribosomal protein L23 (rplW) ↗
- 50S ribosomal protein L24 (rplX) ↗
- 50S ribosomal protein L25 (rplY) ↗
- 50S ribosomal protein L27 (rpmA) ↗
- 50S ribosomal protein L28 (rpmB) ↗
- 50S ribosomal protein L29 (rpmC) ↗
- 50S ribosomal protein L2 (rplB) ↗
- 50S ribosomal protein L30 (rpmD) ↗
- 50S ribosomal protein L31 type B (ykgM) ↗
- 50S ribosomal protein L31 (rpmE) ↗
- 50S ribosomal protein L32 (rpmF) ↗
- 50S ribosomal protein L33 (rpmG) ↗
- 50S ribosomal protein L34 (rpmH) ↗
Combination products
casporyn hc
with urea, polymyxin b sulfate
Also known as neomycin and polymyxin b sulfates and hydrocortisone, oticair, pediotic
coly-mycin s
with urea, thonzonium bromide, colistin
cordran n
with flurandrenolide
cortisporin
with urea, bacitracin, polymyxin b sulfate
Also known as bacitracin-neomycin-polymyxin w/ hydrocortisone acetate, neomycin and polymyxin b sulfates, bacitracin zinc and hydrocortisone
lanabiotic
maxitrol
with polymyxin b sulfate, dexamethasone
Also known as dexacidin, dexasporin, neomycin and polymyxin b sulfates and dexamethasone
neo-cort-dome
with urea
Also known as cor-oticin, neo-cortef
neodecadron
with dexamethasone
neo-delta-cortef
with prednisone
neo-hydeltrasol
with prednisolone
neo-medrol acetate
with methylprednisolone
neomycin sulfate-triamcinolone acetonide
with triamcinolone
Also known as mytrex a
neo-polycin
with bacitracin, polymyxin b sulfate
Also known as neomycin and polymyxin b sulfates and bacitracin zinc
neosporin
with polymyxin b sulfate, gramicidin
Also known as neomycin and polymyxin b sulfates and gramicidin
neosporin g.u. irrigant
with polymyxin b sulfate
Also known as neomycin and polymyxin b sulfate, statrol
neo-synalar
poly-pre
Approval history
- approvedApr 19, 1954
Chemistry & pharmacology
SMILES
NC[C@@H]1O[C@H](O[C@H]2[C@@H](O)[C@H](O[C@@H]3[C@@H](O)[C@H](N)C[C@H](N)[C@H]3O[C@H]4O[C@H](CN)[C@@H](O)[C@H](O)[C@H]4N)O[C@@H]2CO)[C@H](N)[C@@H](O)[C@@H]1O.OS(=O)(=O)O- Mol. weight
- 712.73 g/mol
- Lipinski Ro5
- 3 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Topical
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL3989751 ↗
- WikipediaNeomycin ↗
- NCATSI16QD7X297 ↗
- ChEMBLCHEMBL2104426 ↗
- ChEMBLCHEMBL184618 ↗
- ChEMBLCHEMBL1275977 ↗
Also known as
- bykomycin
- cicatrene
- cicatrin
- cicatrin
- cicatrin
- endomixin
- fradiomycin sulfate
- fradiomycin sulfate
- fradiomycin sulfate
- framycetin
- framycetin
- gppe nsl gel
- graneodin
- mycerin sulfate
- mycifradin
- mycifradin
- mycifradin
- myciguent
- myciguent
- naseptin
- neobacrin
- neomycin
- neomycin
- neomycin
- neomycin
- neomycin
- neomycin
- neomycin
- neomycin b
- neomycin b sulfate
- neomycin b sulfate
- neomycin b sulfate
- neomycin b sulfate
- neomycin b sulfate
- neomycin b sulfate
- neomycin sulfate
- neomycin sulfate
- neomycin sulfate
- neomycin sulfate
- neomycin sulfate
- neomycin sulfate
- neomycin sulfate
- neomycin sulfate
- neomycin sulfate
- neomycin sulphate
- neo-rx
- neo-rx
- nivemycin
- nivemycin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07032506 | N/A | Oct 31, 2025 | Cornell University |
| NCT06889701 | Phase 1/Phase 2 (Phase 2) | Apr 3, 2025 | TenNor Therapeutics Ltd, Xinjiang Medical University |
| NCT06747611 | Early Phase 1 (Phase 1) | Jan 15, 2025 | University of Minnesota |
| NCT06080698 | N/A | Jan 1, 2024 | Johns Hopkins University, Patient-Centered Outcomes Research Institute |
| NCT06148025 | Phase 4 | Nov 30, 2023 | Flinders University, South Australian Health and Medical Research Institute, Telethon Kids Institute, University of Adelaide, University of Sydney |
| NCT06093191 | Phase 4 | Sep 25, 2023 | Huazhong University of Science and Technology |
| NCT05874219 | Phase 2/Phase 3 (Phase 3) | Apr 10, 2023 | Future University in Egypt |
| NCT05999955 | N/A | Dec 29, 2022 | Huro Biotech Joint Stock Company, Thai Binh University of Medicine and Pharmacy, Vietstar Biomedical Research |
| NCT05593601 | Phase 4 | Nov 24, 2022 | Mahidol University |
| NCT05449392 | Phase 1 | Sep 1, 2022 | Bill and Melinda Gates Foundation, Yale University |
| NCT04729322 | Early Phase 1 (Phase 1) | Feb 22, 2021 | National Cancer Institute (NCI), University of Texas at Houston |
| NCT04281667 | Phase 4 | Feb 29, 2020 | University of Helsinki |
| NCT03856671 | N/A | May 17, 2019 | Sun Yat-Sen University |
| NCT04438655 | N/A | May 1, 2019 | University of Turin |
| NCT03663504 | Phase 4 | Oct 1, 2018 | University of Ottawa |
| NCT03476317 | Phase 2 | Jul 12, 2018 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Pennsylvania |
| NCT03557008 | Phase 4 | Jul 5, 2018 | Emory University |
| NCT03006809 | Phase 1 | Jun 15, 2017 | University of California, San Francisco |
| NCT02973880 | Phase 3 | Feb 1, 2017 | Catholic University of Sacred Heart, Rome, SIFI SpA, Sintesi Research Srl |
| NCT02682485 | Phase 2 | Jan 1, 2017 | University of Chicago |
Organizations
Research & Development (66)
Marketing (59)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | — |
| Akorn, Inc. | For profit | MKTG | Oct 26, 1968 |
| Alcon | For profit | MKTG | Mar 12, 1974 |
| Alcon | For profit | NDA2 | Jun 6, 1963 |
| Alcon | For profit | SYN | Jul 21, 1986 |
| Alcon | For profit | NDA | — |
| Allergan | For profit | MKTG | May 10, 1963 |
| Allergan | For profit | NDA2 | May 10, 1963 |
| Altana | For profit | MKTG | — |
| Amring Pharmaceticals | For profit | MKTG | Oct 28, 2005 |
| Bausch & Lomb | For profit | MKTG | Jul 25, 1994 |
| Bayer | For profit | MKTG | Oct 19, 1964 |
| Bayer | For profit | NDA2 | Oct 19, 1964 |
| Bristol-Myers Squibb | For profit | MKTG | — |
| Casper Pharma LLC | For profit | MKTG | May 10, 1971 |
| Casper Pharma LLC | For profit | NDA2 | May 10, 1971 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jun 10, 2016 |
| Dow Pharmaceutical Sciences | For profit | MKTG | Apr 19, 1954 |
| Eli Lilly | For profit | NDA2 | — |
| Eli Lilly | For profit | MKTG | — |
| Endo Pharmaceuticals | For profit | MKTG | May 17, 1962 |
| Endo Pharmaceuticals | For profit | NDA2 | May 17, 1962 |
| Epic Pharma Llc | For profit | MKTG | Oct 26, 1968 |
| Esteve Labs | For profit | MKTG | Mar 29, 2010 |
| Esteve Labs | For profit | SYN | Mar 29, 2010 |
| Fougera | For profit | MKTG | — |
| GlaxoSmithKline | For profit | NDA2 | — |
| Harrow Health | For profit | NDA2 | Jun 6, 1963 |
| Lannett Company, Inc. | For profit | MKTG | Oct 26, 1966 |
| Lannett Company, Inc. | For profit | SYN | Jun 10, 2016 |
| Medimetriks | For profit | MKTG | Jun 11, 1963 |
| Merck | For profit | MKTG | Jul 2, 1969 |
| Merck | For profit | NDA2 | Jul 2, 1969 |
| Monarch Pharmaceuticals | For profit | MKTG | Mar 26, 1957 |
| Monarch Pharmaceuticals | For profit | NDA2 | Mar 26, 1957 |
| Naska Pharmacal | For profit | MKTG | — |
| Nestle | For profit | MKTG | Nov 30, 1984 |
| Nostrum Laboratories | For profit | MKTG | Mar 29, 2010 |
| Novartis | For profit | MKTG | Oct 29, 1984 |
| Novartis | For profit | SYN | Jun 6, 1963 |
| Novartis | For profit | NDA2 | Jul 19, 1963 |
| Padagis Us | For profit | MKTG | Jan 22, 1981 |
| Perrigo | For profit | MKTG | Jan 22, 1981 |
| Pfizer | For profit | NDA2 | Mar 13, 2009 |
| Pfizer | For profit | MKTG | — |
| Pharmacia & Upjohn | For profit | NDA2 | Dec 7, 1964 |
| Pharmacia & Upjohn | For profit | MKTG | Dec 7, 1964 |
| Pharmaderm | For profit | MKTG | — |
| Pharmafair | For profit | MKTG | — |
| Roxane Laboratories | For profit | MKTG | — |
| Sandoz | For profit | MKTG | Aug 25, 1983 |
| Sandoz | For profit | SYN | Aug 25, 1983 |
| Savage Labs | For profit | MKTG | — |
| Schering | For profit | MKTG | — |
| Teva | For profit | MKTG | Sep 2, 1964 |
| Watson Pharmaceuticals | For profit | MKTG | Apr 8, 1986 |
| X Gen Pharmaceuticals | For profit | SYN | Jan 31, 2006 |
| X Gen Pharmaceuticals | For profit | MKTG | Jan 5, 1972 |
| iPharma | For profit | MKTG | — |