Teslac

(Testolactone)

Phase 3Small molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Teslac is one of 29 small molecule programs targeting Precocious Puberty. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Precocious PubertyActive, not recruiting

Congenital Adrenal HyperplasiaActive, not recruiting

Precocious PubertyPhase 2

Active, not recruiting

Congenital Adrenal HyperplasiaPhase 3

Active, not recruiting

Competition

Competitive Landscape

27 competitors in Congenital Adrenal Hyperplasia

#DrugCompanyPhaseTrials

Florinef

Alnylam Pharmaceuticals

Phase 3

2 2

Femara

Novartis

Phase 3

1 3

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

6 4

Eulexin

SSchering-Plough

Phase 3

1 5

Crenessity

Neurocrine Biosciences

Phase 3

4 6

Decadron

AAspen Global Incorporated

Phase 2

1 7

Teslac

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

1 8

Lu AF95245

Lundbeck

Phase 2

1 9

Zytiga

Johnson & Johnson

Phase 1

2 10

Chronocort

NNeurocrine UK Limited

Phase 3

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

Clinical

Trials by Indication[1]

Precocious Puberty2 trials

Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2·NCT00001181·100 enrolled

Treatment of Boys With Precocious Puberty

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2·NCT00001202·80 enrolled

Congenital Adrenal Hyperplasia1 trial

Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00001521·66 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

TESLAC

NDA NDA016119

Jan 1, 1982

TESLAC

NDA NDA016118

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Testolactone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Testolactone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Testolactone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA016119). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Teslac

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Precocious Puberty2 trials

Congenital Adrenal Hyperplasia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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