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Paromomycin

Generic Name
Paromomycin
Brand Names
Humatin
Drug Type
Small Molecule
Chemical Formula
C23H45N5O14
CAS Number
7542-37-2
Unique Ingredient Identifier
61JJC8N5ZK
Background

An oligosaccharide antibiotic produced by various streptomyces. [PubChem]

Indication

For the treatment of acute and chronic intestinal amebiasis (it is not effective in extraintestinal amebiasis). Also for the management of hepatic coma as adjunctive therapy.

Associated Conditions
Dientamoeba fragilis infection, Hepatic coma, Acute Intestinal amebiasis, Chronic Intestinal amebiasis
Clinical Trials
Related News

Appili Therapeutics Advances ATI-1801 Development for Cutaneous Leishmaniasis with FDA Alignment

• Appili Therapeutics has secured FDA alignment on development requirements for ATI-1801, a novel topical paromomycin formulation for treating cutaneous leishmaniasis, paving the way for NDA submission. • The company's LIKMEZ™, the first FDA-approved liquid metronidazole formulation, has launched in the U.S. market through partner Saptalis Pharmaceuticals, offering a new option for patients with swallowing difficulties. • Shareholders have approved a pending acquisition by Aditxt Inc., with the transaction expected to close in Q1 2025, subject to financing conditions.

Appili Therapeutics Advances Pipeline with FDA-Approved Drug Launch and Vaccine Progress

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Appili Therapeutics Gains FDA Alignment on ATI-1801 Development for Leishmaniasis

• Appili Therapeutics has received positive feedback from the FDA regarding its development strategy for ATI-1801, a topical antiparasitic product. • ATI-1801 is being developed for the treatment of leishmaniasis, a disfiguring parasitic disease with significant unmet medical needs. • The FDA's feedback supports Appili's plan to submit a New Drug Application (NDA) for ATI-1801, potentially expediting its availability to patients. • Aditxt, Inc., which is in the process of acquiring Appili Therapeutics, views this alignment as a crucial milestone for its infectious disease program.

Appili Therapeutics Receives Positive FDA Feedback on ATI-1801 Development for NDA Submission

• Appili Therapeutics announced that the FDA has provided positive feedback on its development strategy for ATI-1801, a topical antiparasitic product. • The FDA's feedback aligns with the requirements for a New Drug Application (NDA) submission, marking a significant milestone for the drug's development. • Aditxt's planned acquisition of Appili Therapeutics could be bolstered by the progress of ATI-1801 towards potential market approval.

Appili Therapeutics Gains FDA Alignment on ATI-1801 for Cutaneous Leishmaniasis

• Appili Therapeutics announced FDA agreement on the development strategy for ATI-1801, a topical paromomycin formulation, streamlining its path to NDA submission. • The FDA's feedback allows Appili to leverage existing clinical data, including Phase 3 results, reducing the need for additional clinical trials. • ATI-1801 has demonstrated safety and efficacy in multiple Phase 2 and Phase 3 studies and holds Orphan Drug Designation for cutaneous leishmaniasis. • Subject to funding, Appili plans to advance ATI-1801 topical paromomycin cream (15% w/w) program to NDA submission.
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