Last reviewed 2026-04-20 · How we verify

DOTATOC-68Ga PET initial

Central Hospital, Nancy, France · Phase 1 active Small molecule Quality 0/100

DOTATOC-68Ga PET initial is a Small molecule drug developed by Central Hospital, Nancy, France. It is currently in Phase 1 development. Also known as: Imaging PET/CT.

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	DOTATOC-68Ga PET initial
Also known as	Imaging PET/CT
Sponsor	Central Hospital, Nancy, France
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

DOTATOC-68Ga PET initial CI brief — competitive landscape report
DOTATOC-68Ga PET initial updates RSS · CI watch RSS
Central Hospital, Nancy, France portfolio CI

Frequently asked questions about DOTATOC-68Ga PET initial

What is DOTATOC-68Ga PET initial?

DOTATOC-68Ga PET initial is a Small molecule drug developed by Central Hospital, Nancy, France.

Who makes DOTATOC-68Ga PET initial?

DOTATOC-68Ga PET initial is developed by Central Hospital, Nancy, France (see full Central Hospital, Nancy, France pipeline at /company/central-hospital-nancy-france).

Is DOTATOC-68Ga PET initial also known as anything else?

DOTATOC-68Ga PET initial is also known as Imaging PET/CT.

What development phase is DOTATOC-68Ga PET initial in?

DOTATOC-68Ga PET initial is in Phase 1.

Manufacturer: Central Hospital, Nancy, France — full pipeline
Also known as: Imaging PET/CT

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