Estinyl

(ethinyl estradiol)

Phase 3Small molecule

OOrganon and Co

Estinyl is one of 110 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Phase 3.

Indications

Total Trials

Active Trials

109

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Systemic Lupus ErythematosusActive, not recruiting

Turner SyndromeActive, not recruiting

Endometrial CancerActive, not recruiting

Advanced MalignanciesRecruiting

Systemic Lupus ErythematosusPreclinical

Active, not recruiting

Turner SyndromePhase 3

Active, not recruiting

Endometrial CancerPhase 2

Active, not recruiting

Advanced MalignanciesPhase 1

Recruiting

Competition

Competitive Landscape

328 competitors in Systemic Lupus Erythematosus

#DrugCompanyPhaseTrials

Eptanemab

UCB

Phase 3

12 2

Medrol

Pfizer

Phase 3

5 3

Stelara

Johnson & Johnson

Phase 3

3 4

Rinvoq

AbbVie

Phase 3

3 5

Cytoxan

BBaxter Healthcare Corporation

Phase 3

11 6

Rayos

RRoxane Laboratories

Phase 3

6 7

Benadryl

PParkedale

Phase 3

3 8

Imuran

LLegacy Health System

Phase 3

2 9

Proleukin

IIovance Biotherapeutics, Inc.

Diphenhydramine Hcl

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2028

Phase 1Recruiting

Advanced Malignancies

NCT07340190

Clinical

Trials by Indication[1]

Systemic Lupus Erythematosus1 trial

Randomized Study of Oral Contraceptives or Hormone Replacement Therapy in Women With Systemic Lupus Erythematosus

Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00006133·970 enrolled

Ovulation1 trial

Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

Completed· Pfizer logo

Pfizer·Phase 2·NCT00254189·60 enrolled

Overweight1 trial

A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06039826·46 enrolled

Turner syndrome1 trial

Somatropin Treatment to Final Height in Turner Syndrome

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00191113·154 enrolled

Endometrial Cancer1 trial

Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00033358·52 enrolled

3 more indications

Ovarian Function1 trial

A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)

Completed·OOrganon and Co·Phase 2·NCT01709318·666 enrolled

Pregnancy1 trial

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled

Advanced Malignancies1 trial

A Phase 1b, Open Label, 2-Part Study to Evaluate the Effect of Pelabresib (DAK539/CPI-0610) on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Patients With Advanced Malignancies

Recruiting· Novartis logo

Novartis·Phase 1·NCT07340190·24 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

ESTINYL

NDA NDA005292

Jan 1, 1982

FEMINONE

NDA NDA016649

Jan 1, 1982

LYNORAL

NDA NDA005490

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for ethinyl estradiol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ethinyl estradiol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ethinyl estradiol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA005292). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: OOrganon and Co

Estinyl

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2028

Trials by Indication[1]

Systemic Lupus Erythematosus1 trial

Ovulation1 trial

Overweight1 trial

Turner syndrome1 trial

Endometrial Cancer1 trial

Ovarian Function1 trial

Pregnancy1 trial

Advanced Malignancies1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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