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levothyroxine

Generic: LEVOTHYROXINE SODIUM·Brand: ERMEZA, EUTHYROX, Ermeza, Euthyrox, LEVO-T, LEVOLET, LEVOTHYROXINE SODIUM, LEVOXYL, Levo-T, Levoxyl, SYNTHROID, Synthroid, THYQUIDITY, THYRO-TABS, TIROSINT, TIROSINT-SOL, Thyquidity, Thyro-Tabs, ThyroKare, Thyrocryn, Thyrolar, Tirosint, UNITHROID, Unithroid

levothyroxine: developed by 3 companies · 3 clinical trials tracked · 4 FDA decisions.

levothyroxine evidence translation

What we can confirm

4 FDA records · 3 tracked trials

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about levothyroxine, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 1 study sponsors
Development Pipeline (4)
CompanyPhase
ANI PHARMACEUTICALS INC (ANIP)Approved
MAIA Biotechnology, Inc. (MAIA)Approved
MAIA Biotechnology, Inc. (MAIA)Approved
DR REDDYS LABORATORIES LTD (RDY)Approved
Clinical Trials (3)

Thyroid Hormone Replacement After Radio Iodine: Value and Efficacy

NCT06647602·N/A·ENTA
Not yet recruiting

Primary endpoint: TSH after two weeks of TH substitution

Observational40 targetStarted 2026-09Completion 2028-122 sites · NetherlandsUniversity Medical Center Groningen

Low Dose Thyroid Hormone, Mitochondrial Fatty Acid Oxidation, and Treatment of Nonalcoholic Steatohepatitis (NASH)

NCT05526144·Phase 2·ENTA
Recruiting

Primary endpoint: Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points

InterventionalRandomizedtriple128 targetStarted 2023-04Completion 2029-121 site · United StatesVA Office of Research and Development

A Randomized, Double-blind, Dose-Conversion Study to Evaluate the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Subjects With Primary Hypothyroidism Who Are Euthyroid on Levothyroxine Replacement Therapy

NCT05712421·Phase 2·ENTA
Completed

Primary endpoint: The ratio of the LT4 dose (mcg/day) at screening to North Star (mg/day) at the end of the treatment period required to achieve and maintain serum thyroid-stimulating hormone (TSH) levels within the normal reference range.

InterventionalRandomizedquadruple303 enrolledStarted 2023-02Completion 2025-0931 sites · United StatesNeuvosyn Laboratories, LLC
FDA Decisions4 records
Approval1 INDICATIONS AND USAGE Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the manag(ANIP)FDA ↗
ANDA213256UNKNOWNStandardOralCapsule
Approval1 INDICATIONS AND USAGE Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the manag(ANIP)FDA ↗
ANDA211369UNKNOWNStandardOralCapsule
Approval1 INDICATIONS AND USAGE Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the manag(RDY)FDA ↗
ANDA208837UNKNOWNStandardIntravenousPowder
Approval1 INDICATIONS AND USAGE Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not been studied. Levothyroxine Sodium is an L-thyroxine product. Levothyroxine (MAIA)FDA ↗
ANDA208749UNKNOWNStandardIntravenousPowder

Frequently asked questions

Who is developing levothyroxine?

levothyroxine is being developed by ANI PHARMACEUTICALS INC, MAIA Biotechnology, Inc., DR REDDYS LABORATORIES LTD.

How many clinical trials involve levothyroxine?

BioSniper tracks 3 clinical trials involving levothyroxine.

What is levothyroxine's latest FDA decision?

The most recent tracked FDA decision for levothyroxine is Approval for 1 INDICATIONS AND USAGE Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the manag, dated January 6, 2021.