Last reviewed 2026-06-02 · How we verify

99mTc-Etarfolatide

Endocyte · Phase 1 active Small molecule Under review

99mTc-Etarfolatide is a radioligand Small molecule drug developed by Endocyte. It is currently in Phase 1 development for Ovarian cancer, Breast cancer. Also known as: EC20, etarfolatide.

binds to folate receptor beta

99mTc-Etarfolatide is a small molecule modality used in medical imaging, specifically in conditions such as non-small cell lung cancer and ovarian cancer. It is a technetium-99m labeled folate receptor-targeting agent, which is used in various clinical trials in combination with other treatments like docetaxel.

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	99mTc-Etarfolatide
Also known as	EC20, etarfolatide
Sponsor	Endocyte
Drug class	radioligand
Target	folate receptor beta
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 1

Mechanism of action

99mTc-Etarfolatide is a radioligand that binds to folate receptor beta, allowing for imaging of folate receptor-positive tumors.

Approved indications

Ovarian cancer
Breast cancer

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:

99mTc-Etarfolatide CI brief — competitive landscape report
99mTc-Etarfolatide updates RSS · CI watch RSS
Endocyte portfolio CI

Frequently asked questions about 99mTc-Etarfolatide

What is 99mTc-Etarfolatide?

99mTc-Etarfolatide is a radioligand drug developed by Endocyte, indicated for Ovarian cancer, Breast cancer.

How does 99mTc-Etarfolatide work?

binds to folate receptor beta

What is 99mTc-Etarfolatide used for?

99mTc-Etarfolatide is indicated for Ovarian cancer, Breast cancer.

Who makes 99mTc-Etarfolatide?

99mTc-Etarfolatide is developed by Endocyte (see full Endocyte pipeline at /company/endocyte).

Is 99mTc-Etarfolatide also known as anything else?

99mTc-Etarfolatide is also known as EC20, etarfolatide.

What drug class is 99mTc-Etarfolatide in?

99mTc-Etarfolatide belongs to the radioligand class. See all radioligand drugs at /class/radioligand.

What development phase is 99mTc-Etarfolatide in?

99mTc-Etarfolatide is in Phase 1.

What does 99mTc-Etarfolatide target?

99mTc-Etarfolatide targets folate receptor beta and is a radioligand.

Drug class: All radioligand drugs
Target: All drugs targeting folate receptor beta
Manufacturer: Endocyte — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Ovarian cancer
Indication: Drugs for Breast cancer
Also known as: EC20, etarfolatide

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