How many clinical trials are studying Imlunestrant?

4 recruiting trials in our tracked data involve Imlunestrant.

What conditions is Imlunestrant being studied for?

In our tracked recruiting trials, Imlunestrant is being studied in trials for Breast Cancer, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8.

Imlunestrant: clinical trials recruiting now

Q: Is Imlunestrant FDA-approved?

Yes. According to the FDA drug label available through openFDA, Imlunestrant is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Imlunestrant appears in the FDA drug-label database. Marketed as Inluriyo.
Drug class: Estrogen Receptor Antagonist (FDA established pharmacologic class)
Mechanism of action: Estrogen Receptor Antagonists; P-Glycoprotein Inhibitors; Breast Cancer Resistance Protein Inhibitors (as stated on the FDA label)

FDA-approved use

INLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. INLURIYO TM is an estrogen receptor antagonist indicated for: treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy ( 1 )

FDA label via openFDA

Phase breakdown

Phase 1 2 Phase 2 3

Conditions being studied

Condition	Trials
Breast Cancer · Imlunestrant for Breast Cancer	4
Anatomic Stage I Breast Cancer AJCC v8	1
Anatomic Stage II Breast Cancer AJCC v8	1
Anatomic Stage III Breast Cancer AJCC v8	1
Breast Neoplasms	1
Invasive Breast Carcinoma	1
Localized Estrogen Receptor-Positive Breast Carcinoma	1
Localized Human Epidermal Growth Factor Receptor (HER2)-Negative Breast Carcinoma	1
Solid Tumors, Adult	1

Recruiting trials involving Imlunestrant

A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
NCT07287098 · Phase: Phase 2 · Ages: 18 Years and older · Sex: Female · 89 locations
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
NCT05307705 · Phase: Phase 1 · Ages: 18 Years and older · Sex: All (male and female) · 50 locations
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
NCT05768139 · Phase: Phase 1, Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 65 locations
Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial
NCT07191717 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location

Common questions

Is Imlunestrant FDA-approved?

Yes, marketed as Inluriyo.

How many recruiting trials involve Imlunestrant?

4 recruiting trials across 9 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.