Levothyroxine
As of the edition of 20 October 2026, Levothyroxine is a small molecule: marketed, first approved in 1951 (CA); acts on THRA and THRB.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Unithroid
- First approved
- 31 December 1951 (CA)
- Approvals on record
- 130 in 5 regions
- Holder of the most recent approval
- IBSA Institut Biochimique; 15 holders in all
- Registered trials
- 116, 15 stopped early
- Disease areas
- Hormones; Cancer; Nutrition and metabolism; Nervous system; Heart and blood vessels; Pregnancy and women's health
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
6 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product6 company-target rows are on route B because of Levothyroxine.
See the 6 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 43 | 20 | 10 | 4 |
| Phase 1 | 18 | 15 | 2 | 1 |
| Phase 2 | 9 | 5 | 3 | 1 |
| Phase 3 | 16 | 9 | 5 | 2 |
| Phase 4 | 30 | 14 | 1 | 7 |
| All trials | 116 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Abbott | Later holder | 2002 to now |
| Viatris | Later holder and Lead sponsor of trials | 2003 to now |
| Jerome Stevens Pharmaceuticals | Acquired holder | 2003 to now |
| IBSA Institut Biochimique | Applicant and Lead sponsor of trials | 2006 to now |
| AbbVie | Acquired holder and Lead sponsor of trials | 2012 to now |
| Fresenius Kabi | Acquired holder | 2013 to now |
| Pfizer | Acquired holder | 2017 to now |
| Genus Life Sciences | Acquired holder | 2017 to now |
| Cediprof | Acquired holder | 2018 to now |
| ASKA Pharmaceutical | Applicant | 2020 to now |
| Alvogen | Acquired holder | 2021 to now |
| Hikma Pharmaceuticals | Acquired holder | 2022 to now |
| Merck KGaA | Acquired holder | 2025 to now |