Last reviewed 2026-05-23 · How we verify

tedguglutide

Shire · Phase 1 active Small molecule ✓ Verified May 2026

tedguglutide is a Small molecule drug developed by Shire. It is currently in Phase 1 development. Also known as: Gattex.

Teduglutide is a medication that has been studied in a double-blind multi-dose tolerability and pharmacokinetic study. The study, which was conducted by Takeda, aimed to evaluate the pharmacokinetics and safety of elevated doses of teduglutide.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	tedguglutide
Also known as	Gattex
Sponsor	Shire
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

tedguglutide CI brief — competitive landscape report
tedguglutide updates RSS · CI watch RSS
Shire portfolio CI

Frequently asked questions about tedguglutide

What is tedguglutide?

tedguglutide is a Small molecule drug developed by Shire.

Who makes tedguglutide?

tedguglutide is developed by Shire (see full Shire pipeline at /company/shire).

Is tedguglutide also known as anything else?

tedguglutide is also known as Gattex.

What development phase is tedguglutide in?

tedguglutide is in Phase 1.

Manufacturer: Shire — full pipeline
Therapeutic area: All drugs in Other
Also known as: Gattex

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing