Drugs / Spinosad
Spinosad
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | Natroba™ | head lice, scabies | 2026-01-28 | “Health Canada has accepted for review Cipher’s new drug submission (“ NDS ”) for Natroba™ (Spinosad), for the treatment of head lice and scabies.” cipherpharma.com ↗ |
| Label expansions (2) | US (FDA) | NATROBA | — | 2014-12-30 – 2021-04-28 | fda.gov ↗ |
| Approved | US (FDA) | NATROBA | — | 2011-01-18 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT00605956 | Jan → Feb 2008 | Pediculus humanus capitis infestation | ParaPRO LLC | Completed | No outcome recorded |
| Phase 1 | NCT00591331 | Dec 2007 | Pediculus humanus capitis infestation | ParaPRO LLC | Completed | No outcome recorded |
| Phase 1 | NCT00410709 | Dec 2006 → Jan 2007 | Pediculus humanus capitis infestation | ParaPRO LLC | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT00988494 | Sep 2009 → ? | corneal disorder | Santen Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00311779 | Mar → Jul 2006 | Pediculus humanus capitis infestation | ParaPRO LLC | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT02485704 | May 2017 → Aug 2018 | scabies | ParaPRO LLC | Completed | No outcome recorded |
| Phase 3 | NCT02485717 | May 2017 → Jun 2018 | scabies | ParaPRO LLC | Completed | No outcome recorded |
| Phase 3 | NCT00545753 | Sep 2007 → Mar 2008 | lice infestation | ParaPRO LLC | Completed | No outcome recorded |
| Phase 3 | NCT00545168 | Sep 2007 → Mar 2008 | Pediculus humanus capitis infestation | ParaPRO LLC | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05310734 | Mar 2022 → Nov 2025 | scabies | Cipher Pharmaceuticals Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT01660321 | Sep → Oct 2011 | lice infestation | ParaPRO LLC | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT06720896 Comparator | Nov 2025 → Jun 2026 overdue | blepharitis | Aperta Biosciences, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00858481 Comparator | Sep → Nov 2005 | Pediculus humanus capitis infestation | ParaPRO LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-01-28 | Cipher Pharmaceuticals Inc. | Regulatory Cipher Pharmaceuticals Announces Health Canada’s Acceptance for Review of New Drug Submission for Natroba™ (Spinosad) cipherpharma.com ↗
today announced that Health Canada has accepted for review Cipher’s new drug submission (“ NDS ”) for Natroba™ (Spinosad), for the treatment of head lice and scabies. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-01-28 | Cipher Pharmaceuticals Inc. | Cipher Pharmaceuticals Announces Health Canada’s Acceptance for Review of New Drug Submission for Natroba™ (Spinosad) cipherpharma.com ↗ |
| 2025-04-29 | Cipher Pharmaceuticals Inc. | Cipher Pharmaceuticals Secures Medicaid Step-Through Preferred Status for Natroba TM in the state of Illinois cipherpharma.com ↗ |
Evidence & citations 25 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Spinosad | “Spinosad (the active ingredient in NatrOVA) and its formulations have been approved as agricultural insecticides in the US, Canada and Australia, and has received provisional...” NCT00410709 ↗11“NatrOVA Creme Rinse - 1% spinosad” NCT00605956 ↗ |
| Known as | APT-001 | “APT-001 topical ophthalmic ointment (spinosad)” NCT06720896 ↗ |
| Known as | Blackhawk | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | Comfortis | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | Conserve | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | DE-105 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00988494 ↗ |
| Known as | Entrust | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | Extinosad | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | Justice | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | LY-232105 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | Natroba | “Natroba (spinosad) topical suspension versus placebo” NCT02485717 ↗1“Natroba” NCT05310734 ↗ |
| Known as | Natroba (spinosad) | “Natroba (spinosad)” NCT02485704 ↗ |
| Known as | Natroba (spinosad) Topical Suspension, 0.9% | “Natroba (spinosad) Topical Suspension, 0.9%” NCT02485717 ↗4“Natroba (spinosad) Topical Suspension, 0.9%” NCT01660321 ↗ “Natroba (spinosad) Topical Suspension, 0.9%” NCT00545168 ↗ “Natroba (spinosad) Topical Suspension, 0.9%” NCT02485704 ↗ “Natroba (spinosad) Topical Suspension, 0.9%” NCT00545753 ↗ |
| Known as | Natrova | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | Naturalyte | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | PP-105 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | Spinosad (ema epar: veterinary) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | Spinosad component of trifexis | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | Spinosyns spinosad | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | Spintor | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | Success | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | Tracer | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Known as | XDE-105 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297065 ↗ |
| Modality | Small molecule | — CHEMBL4297065 ↗ |
| Route | Topical | “Spinosad topical creme” NCT00311779 ↗ |