Natroba

(Spinosad)

ApprovedSmall molecule

DDeciphera Pharmaceuticals, LLC

Natroba is one of 28 small molecule programs targeting Lice Infestation. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Lice InfestationActive, not recruiting

OtotoxicityActive, not recruiting

Lice InfestationApproved

Active, not recruiting

OtotoxicityPhase 1

Active, not recruiting

Competition

Competitive Landscape

34 competitors in Ototoxicity

#DrugCompanyPhaseTrials

Cysteine Hydrochloride

Novartis

Phase 3

3 2

Qualaquin

BBiomed Industries, Inc.

Approved

1 3

Atovaquone/proguanil

Pfizer

Approved

1 4

Artemether/lumefantrine

Merck & Co.

Approved

1 5

Natroba

DDeciphera Pharmaceuticals, LLC

Approved

1 6

Crestor

AstraZeneca

Phase 2

1 7

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 2

1 8

N-Acetyl Cyteien

SStanford University

Phase 2

2 9

Ginkgo Biloba Extract

NNational Center for Complementary and Integrative Health (NCCIH)

Phase 2

1 10

Avlosulfon

AAlmirall, S.A.

Phase 1

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Safety and Efficacy4 trials

Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice

Completed·PParaPRO LLC·Phase 3·NCT00545753·558 enrolled

Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice

Completed·PParaPRO LLC·Phase 3·NCT00545168·480 enrolled

Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies

Completed·PParaPRO LLC·Phase 3·NCT02485704·280 enrolled

Show 1 more trial

Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies

Completed·PParaPRO LLC·Phase 3·NCT02485717·291 enrolled

OSA2 trials

A Pilot Dose Ranging Study of Spinosad Creme Rinse

Completed·PParaPRO LLC·Phase 2·NCT00858481·36 enrolled

A Dose Ranging Study of Different Strengths of Spinosad Topical Creme in Subjects With Pediculosis Capitis

Completed·PParaPRO LLC·Phase 2·NCT00311779·120 enrolled

Lice Infestation1 trial

Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation

Completed·PParaPRO LLC·Phase 4·NCT01660321·26 enrolled

Scabies1 trial

PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies

Recruiting·CCipher Pharmaceuticals Inc.·Phase 4·NCT05310734·50 enrolled

Ototoxicity1 trial

Phototoxicity Potential of NatrOVA Creme Rinse - 1%

Completed·PParaPRO LLC·Phase 1·NCT00591331·37 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 18, 2011

NATROBA

NDA NDA022408

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Spinosad. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Spinosad compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Spinosad. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022408). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Natroba. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Deciphera Pharmaceuticals, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: DDeciphera Pharmaceuticals, LLC

Patent Landscape[5]

Patent Cliff

Nov 25, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9895388Nov 25, 2033

Natroba

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Safety and Efficacy4 trials

OSA2 trials

Lice Infestation1 trial

Scabies1 trial

Ototoxicity1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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