Tirosint
(Levothyroxine Sodium)ApprovedSmall molecule
Tirosint is a small molecule that works as a Thyroid Hormone Receptor Agonist.[2] It is being used across 7 indications, with its most advanced program in Approved.[1]
Tirosint is one of 88 small molecule programs targeting Congenital Hypothyroidism. It is currently in Approved.
7
Indications
19
Total Trials
4
Active Trials
87
Competitors
14
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[3][1]
Indication
Competition
Competitive Landscape
65 competitors in Thyroid Cancer
#DrugCompanyPhaseTrials
1Lenvima
EisaiApproved
Tafinlar
NovartisApproved
Tirosint
IInstitut Jerome Lejeune
Approved
Vitrakvi
BayerApproved
Retevmo
Eli LillyApproved
Rozlytrek
RocheApproved
Caprelsa
GGenzyme, a Sanofi Company
Approved
Nexavar
BayerPhase 3
Mekinist
NovartisPhase 3
Gavreto
RRigel Pharmaceuticals
Approved
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Hypothyroidism3 trials
Thyroid3 trials
Individual Dosing of Levothyroxine After Thyroidectomy
Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·N/A·NCT05240911·202 enrolled
Pregnant Women1 trial
Non-Alcoholic Fatty Liver Disease1 trial
Levothyroxine for Non-Alcoholic Fatty Liver Disease (NAFLD)
Terminated·—·Phase 2·NCT03281083·29 enrolled
7 more indications
Randomized Controlled Trial1 trial
Dialysis Patients1 trial
Treatment1 trial
Low Dose Euthyrox in Treatments of Paraquat Intoxication.
Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04132622·80 enrolled
Congenital Hypothyroidism1 trial
Unspecified4 trials
Regulatory
FDA Approval Timeline[4]
Aug 21, 2000
UNITHROID
NDA NDA021210
May 25, 2001
LEVOXYL
NDA NDA021301
Mar 1, 2002
LEVO-T
NDA NDA021342
May 31, 2002
EUTHYROX
NDA NDA021292
Jul 24, 2002
SYNTHROID
NDA NDA021402
Oct 24, 2002
THYRO-TABS
NDA NDA021116
Jun 6, 2003
LEVOLET
NDA NDA021137
Aug 1, 2007
TIROSINT
NDA NDA021924
Jun 24, 2011
LEVOTHYROXINE SODIUM
NDA NDA202231
Dec 15, 2016
TIROSINT-SOL
NDA NDA206977
Apr 11, 2019
LEVOTHYROXINE SODIUM
NDA NDA210632
Nov 30, 2020
THYQUIDITY
NDA NDA214047
May 17, 2021
LEVOTHYROXINE SODIUM
NDA NDA214253
Apr 29, 2022
ERMEZA
NDA NDA215809
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Levothyroxine Sodium. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Thyroid Hormone Receptor Agonist[2]
- Modality
- Small molecule[2]
- Highest Phase
- Approved[1]
- Company
- IInstitut Jerome Lejeune