Drugs / Docosanol
Docosanol
also known as
Abreva · Behenic alcohol · Behenyl alcohol · Lidakol · N-docosanol · NSC-8407 · Stenol 1822
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ABREVA | — | 2000-07-25 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 41 trial | ||||||
| Phase 4 | NCT00467662 | — | herpes labialis | Hadassah Medical Organization | Unknown | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT06558838 Comparator | Aug 2024 → Nov 2025 | herpes labialis | University of Utah | Completed | No outcome recorded |
| Phase 2 | NCT04893577 Comparator | Jan 2022 → Aug 2024 | herpes labialis | University of Utah | Completed | No outcome recorded |
| Phase 2 | NCT03977792 Comparator | Sep 2020 → Jul 2021 | herpes labialis | Laboratoire Boreaderme Inc. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-05-27 | Cosette Pharmaceuticals, Inc. | Regulatory Cosette Pharmaceuticals and Alembic Pharmaceuticals Limited Announce the Approval and Launch of a National Brand Equivalent (NBE) of Abreva® (Docosanol Cream 10%) Including the First Approval in the Pump Format cosettepharma.com ↗
This approval represents the first ANDA approval in the pump format and Cosette plans to launch the product across the US retail channel. |
| 2022-05-01 | Alembic Pharmaceuticals Ltd. | Regulatory 4th May, 2022, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Docosanol Cream, 10% (OTC). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-05-27 | Cosette Pharmaceuticals, Inc. | Cosette Pharmaceuticals and Alembic Pharmaceuticals Limited Announce the Approval and Launch of a National Brand Equivalent (NBE) of Abreva® (Docosanol Cream 10%) Including the First Approval in the Pump Format cosettepharma.com ↗ |
| 2022-05-01 | Alembic Pharmaceuticals Ltd. | 4th May, 2022, Vadodara, India alembicpharmaceuticals.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Docosanol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03977792 ↗ |
| Known as | Abreva | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04893577 ↗ |
| Known as | Behenic alcohol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200453 ↗ |
| Known as | Behenyl alcohol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200453 ↗ |
| Known as | Lidakol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200453 ↗ |
| Known as | N-docosanol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200453 ↗ |
| Known as | NSC-8407 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200453 ↗ |
| Known as | Stenol 1822 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200453 ↗ |
| Modality | Small molecule | — CHEMBL1200453 ↗ |