Drugs / Spinosad

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
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 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 NCT00545168 Sep 2007 → Mar 2008 Pediculus humanus capitis infestation ParaPRO LLC Completed No outcome recorded
Phase 3 NCT00545753 Sep 2007 → Mar 2008 lice 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
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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

Evidence & citations 25 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited 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% spinosadNCT00605956

NCT01660321

NCT00591331

NCT00311779

NCT02485717

NCT00545168

NCT05310734

NCT00545753

NCT00858481

NCT06720896

NCT02485704

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

NatrobaNCT05310734

Known as Natroba (spinosad) Natroba (spinosad)NCT02485704
Known as Natroba (spinosad) Topical Suspension, 0.9% Natroba (spinosad) Topical Suspension, 0.9%NCT01660321
4

Natroba (spinosad) Topical Suspension, 0.9%NCT02485704

Natroba (spinosad) Topical Suspension, 0.9%NCT00545753

Natroba (spinosad) Topical Suspension, 0.9%NCT02485717

Natroba (spinosad) Topical Suspension, 0.9%NCT00545168

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