Tapazole

(Methimazole)

ApprovedSmall molecule

Methimazole is used to treat an overactive thyroid gland (hyperthyroidism) by reducing the amount of thyroid hormone the body produces.[2] Tapazole is currently approved and in use across 9 indications[4].[1]

Tapazole is one of 181 small molecule programs targeting Hyperthyroidism. It is currently in Approved.

Indications

Total Trials

Active Trials

180

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HyperthyroidismActive, not recruiting

Abnormality of the Thyroid GlandActive, not recruiting

AtherosclerosisActive, not recruiting

Graves DiseaseApproved

PolymyositisApproved

Graves OphthalmopathyApproved

GlioblastomaActive, not recruiting

Glioblastoma MultiformeApproved

DermatomyositisActive, not recruiting

HyperthyroidismPhase 3

Active, not recruiting

Abnormality of the Thyroid GlandApproved

Active, not recruiting

AtherosclerosisPhase 3

Active, not recruiting

Graves DiseaseApproved

Approved

PolymyositisApproved

Approved

Graves OphthalmopathyApproved

Approved

GlioblastomaPhase 1

Active, not recruiting

Glioblastoma MultiformeApproved

Approved

DermatomyositisPhase 2

Active, not recruiting

Competition

Competitive Landscape

514 competitors in Glioblastoma

#DrugCompanyPhaseTrials

Temodar

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

161 2

Tapazole

VViking Therapeutics, Inc.

Approved

2 3

Ceenu

AAzurity Pharmaceuticals

Phase 3

22 4

Gleevec

Novartis

Phase 3

2 5

Cymbalta

Alnylam Pharmaceuticals

Phase 3

1 6

Scemblix

Novartis

Phase 3

1 7

Lexapro

AbbVie

Phase 3

1 8

Sprycel

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

4 9

Zejula

GGlaxo Dba Glaxosmithkline

Phase 3

4 10

Feraheme

AAzurity Pharmaceuticals

Phase 3

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

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Graves Disease

NCT07369063

Q4 2027

Recruiting

Hyperthyroidism

NCT06570967

Q3 2030

Post-ApprovalRecruiting

Graves Disease

NCT05461820

Q4 2030

Recruiting

Graves Disease

NCT07040306

Clinical

Trials by Indication[1]

Graves disease6 trials

Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease

Recruiting·NNorthwell Health·Phase 2·NCT07369063·30 enrolled

Observation in the Treatment of Graves' Disease

Unknown status·SShanghai Jiao Tong University School of Medicine··NCT05043233·1,000 enrolled

A Clinical Follow-up Study on Drug Therapy for Graves' Disease Patients in China

Recruiting·FFirst Hospital of China Medical University··NCT07040306·1,000 enrolled

Show 3 more trials

Effects of Different Treatment Schemes on the Regulation and Recurrence of Graves' Disease

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 4·NCT05461820·240 enrolled

Rituximab in the Treatment of Graves' Disease

Completed·OOdense University Hospital·Phase 1/2·NCT00150111·20 enrolled

Characteristics of Islet β-cell Functions in Chinese Patients With Graves' Disease

Completed·WWeikai Hou··NCT02376088·328 enrolled

Hyperthyroidism3 trials

A Conservative vs an Ablative Approach for Treatment of Hyperthyroidism in Patients With Graves' Orbitopathy

Unknown status·UUniversity of Pisa·Phase 3·NCT04776993·52 enrolled

A Clinical Study of Hyperthyroidism in Children

Recruiting·SShengjing Hospital··NCT06570967·1,000 enrolled

Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole

Completed·UUniversity of Pisa·N/A·NCT02727738·30 enrolled

Glioblastoma2 trials

Methimazole in Patients With Progressive Glioblastoma

Recruiting·—·Phase 2·NCT05607407·19 enrolled

Inducing a Hypothyroxinemic State in Patients With Recurrent Glioblastoma or Gliosarcoma

Withdrawn·EEmory University·Phase 1·NCT05017610

Thyroid2 trials

Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients

Completed·MMashhad University of Medical Sciences·N/A·NCT01560299·150 enrolled

Antithyroid Drugs During Radioiodine Therapy

Completed·OOdense University Hospital·Phase 4·NCT00150137·80 enrolled

Treatment1 trial

Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

Terminated·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·N/A·NCT01893450·31 enrolled

6 more indications

Elderly1 trial

Cardiopulmonary Capacity in Elderly With Different Ranges of Serum Thyroid Stimulating Hormone

Unknown status·UUniversidade Federal do Rio de Janeiro·Phase 4·NCT01849861·200 enrolled

Efficacy1 trial

Efficacy of Methimazole Dosing Algorithm

Terminated·CCook County Health··NCT05964452·11 enrolled

Dermatomyositis1 trial

Methimazole to Treat Polymyositis and Dermatomyositis

Completed·NNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)·Phase 2·NCT00001421·20 enrolled

Atherosclerosis1 trial

Effect of Hyperthyroidism and Its Treatment in Graves' Disease to Early Marker of Atherosclerosis

Completed·IIndonesia University·Phase 3·NCT05118542·36 enrolled

Adjuvant Treatment1 trial

Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study)

Completed·MMikael Lantz·Phase 4·NCT01458600·65 enrolled

Unspecified1 trial

Block-replacement Therapy During Radioiodine Therapy

Completed·SSteen Bonnema·Phase 4·NCT00150124·100 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

TAPAZOLE

NDA NDA007517

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Methimazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tapazole drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Methimazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Methimazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA007517). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Viking Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Thyroid Peroxidase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VViking Therapeutics, Inc.

Tapazole

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Q3 2030

Q4 2030

Trials by Indication[1]

Graves disease6 trials

Hyperthyroidism3 trials

Glioblastoma2 trials

Thyroid2 trials

Treatment1 trial

Elderly1 trial

Efficacy1 trial

Dermatomyositis1 trial

Atherosclerosis1 trial

Adjuvant Treatment1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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