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Home / Peptides / Teriparatide

FDA and NIH data · updated 2026-10-16

Teriparatide: FDA status and clinical evidence

FDA-approved

Teriparatide is approved by the FDA and is on the US market, first approved November 26, 2002, under 7 applications. 182 studies are registered on ClinicalTrials.gov, reaching Phase 4.

Yes
FDA-approved
182
Registered studies
Phase 4
Highest phase
7
FDA applications

FDA approval status

Status
Approved
First approval
November 26, 2002
Most recent approval
December 12, 2025
Applications on file
7
Brand names
BONSITY, FORTEO, PARATHAR, TERIPARATIDE
Sponsors
ALMAJECT, ALVOGEN, AMPHASTAR PHARMS INC, APOTEX, LILLY, SANOFI AVENTIS US, TEVA PHARMS USA
Routes
INJECTION, SUBCUTANEOUS
Dosage forms
INJECTABLE, SOLUTION
Marketing status
Discontinued, Prescription
Reference listed drug
Yes

FDA review documents

Clinical evidence

Registered studies
182
Interventional
159
Completed
114
Currently active
17
Studies with posted results
63
Highest phase reached
Phase 4
Total enrolment across studies
379,761

By phase

Phase 448
Phase 246
Phase 334
Phase 118
Not applicable17

Full trial breakdown for Teriparatide →

Patents and generic availability

Listed in the Orange Book
Yes
Brand applications
4
Generic applications
3
Unexpired patents
None listed

When generic Teriparatide can launch →

Molecular identity

Substance class
Protein
FDA UNII
10T9CSU89I
CAS number
52232-67-4
WHO ATC code
Amino acid sequence
SVSEIQLMHNLGKHLNSMERVEWLRKKLQDVHNF
Sequence length
34 residues
Molecular weight
4120 g/mol
Recorded synonyms
31

From the FDA Global Substance Registration System, the registry that assigns every substance the FDA tracks a unique identifier.

How to read this. This page reports what federal records say about Teriparatide, nothing more. An FDA approval covers specific uses and doses on a reviewed label. A registered trial records that research was declared, not that it succeeded. A listed patent governs who may sell a drug, not whether it works. None of this is medical advice, and none of it means a compound is safe to use outside a prescription.

Frequently asked questions

Is Teriparatide FDA-approved?

Yes. Teriparatide holds FDA approval and is marketed in the US. Approval covers the specific uses, doses and forms on the FDA label, not every use it is sold or discussed for.

How much clinical research is there on Teriparatide?

182 studies are registered on ClinicalTrials.gov with Teriparatide as an intervention, 114 of them completed. The highest phase reached is Phase 4. Registration counts research activity, not proven benefit.

What brand names is Teriparatide sold under?

FDA records list BONSITY, FORTEO, PARATHAR, TERIPARATIDE. Brand availability changes over time, and some applications on file are marked discontinued.

Where does the information on this page come from?

Four FDA and NIH sources: Drugs@FDA for approval records, the FDA Orange Book for patents and exclusivity, the FDA Global Substance Registration System for molecular identity, and ClinicalTrials.gov for trial counts. Each is refreshed on a schedule and the date above shows the last refresh.

Sources: Drugs@FDA, FDA Orange Book, FDA Global Substance Registration System and ClinicalTrials.gov. Last refreshed 2026-10-16.