Last reviewed 2026-06-02 · How we verify

68Ga-NI-FAPI

First Affiliated Hospital of Fujian Medical University · Phase 1 active Small molecule ✓ Verified Jun 2026 Quality 0/100

68Ga-NI-FAPI is a Small molecule drug developed by First Affiliated Hospital of Fujian Medical University. It is currently in Phase 1 development.

68Ga-NI-FAPI is a small molecule used in PET/CT imaging for various conditions, including tumors and cardiovascular diseases. It is being studied in clinical trials for its potential to diagnose and monitor these conditions.

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	68Ga-NI-FAPI
Sponsor	First Affiliated Hospital of Fujian Medical University
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases (PHASE1, PHASE2)
68Ga-NI-FAPI PET/CT: First-in-human Study (EARLY_PHASE1)
68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer (EARLY_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:

68Ga-NI-FAPI CI brief — competitive landscape report
68Ga-NI-FAPI updates RSS · CI watch RSS
First Affiliated Hospital of Fujian Medical University portfolio CI

Frequently asked questions about 68Ga-NI-FAPI

What is 68Ga-NI-FAPI?

68Ga-NI-FAPI is a Small molecule drug developed by First Affiliated Hospital of Fujian Medical University.

Who makes 68Ga-NI-FAPI?

68Ga-NI-FAPI is developed by First Affiliated Hospital of Fujian Medical University (see full First Affiliated Hospital of Fujian Medical University pipeline at /company/first-affiliated-hospital-of-fujian-medical-university).

What development phase is 68Ga-NI-FAPI in?

68Ga-NI-FAPI is in Phase 1.

Manufacturer: First Affiliated Hospital of Fujian Medical University — full pipeline

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