Implanon

(etonogestrel)

ApprovedSmall molecule

Etonogestrel is a birth control medication that prevents pregnancy. It's a small flexible rod implanted under the skin of the arm that releases hormone over several years.[2] Implanon is currently approved and in use across 8 indications[4].[1]

Implanon is one of 226 small molecule programs targeting AIDS. It is currently in Approved.

Indications

Total Trials

Active Trials

225

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

AIDSApproved

ContraceptionActive, not recruiting

HIV InfectionActive, not recruiting

Systemic Lupus ErythematosusActive, not recruiting

Benign Prostatic HyperplasiaApproved

DysmenorrheaActive, not recruiting

EndometriosisActive, not recruiting

Endometrial Hyperplasia Without AtypiaActive, not recruiting

AIDSApproved

Approved

ContraceptionApproved

Active, not recruiting

HIV InfectionPreclinical

Active, not recruiting

Systemic Lupus ErythematosusPhase 2

Active, not recruiting

Benign Prostatic HyperplasiaApproved

Approved

DysmenorrheaPhase 2

Active, not recruiting

EndometriosisApproved

Active, not recruiting

Endometrial Hyperplasia Without AtypiaPreclinical

Active, not recruiting

Competition

Competitive Landscape

328 competitors in Systemic Lupus Erythematosus

#DrugCompanyPhaseTrials

Implanon

OOrganon and Co

Approved

1 2

Rituxan

Roche

Phase 3

9 3

Medrol

Pfizer

Phase 3

5 4

Stelara

Johnson & Johnson

Phase 3

3 5

Rinvoq

AbbVie

Phase 3

3 6

Ocrevus

Roche

Phase 3

2 7

Gazyva

Roche

Phase 3

2 8

Cytoxan

BBaxter Healthcare Corporation

Phase 3

11 9

Intrarosa

Alnylam Pharmaceuticals

Phase 3

1 10

Cellcept

Novartis

Phase 3

—

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Endometrial

NCT05760144

Post-ApprovalRecruiting

Contraception

NCT05237141

Q2 2027

Phase 1Active, not recruiting

Trial

NCT05174884

Clinical

Trials by Indication[1]

Contraception3 trials

Same-day Long-acting Reversible Contraception for Medication Abortion

Completed·—··NCT01356927·40 enrolled

Etonogestrel Implant as Emergency Contraception

Recruiting·UUniversity of Colorado, Denver·Phase 4·NCT05237141·12 enrolled

Hormonal Contraception in Healthy Young Men (P42306)(COMPLETED)(P06057)

Completed·OOrganon and Co·Phase 2·NCT00403793·350 enrolled

ART2 trials

Immediate vs. Delayed Postpartum Etonogestrel Implant

Completed·—·Phase 4·NCT01767285·60 enrolled

Antepartum Etonogestrel Contraceptive Implant Insertion at Term

Withdrawn·UUniversity of Colorado, Denver·Phase 1·NCT03656289

Women2 trials

Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women

Completed·UUniversity of Sao Paulo·N/A·NCT00828542·40 enrolled

Pharmacologic Strategies for the Etonogestrel Implant in HIV-Infected Women

Completed·CCatherine Anne Chappell·Phase 2·NCT03282799·72 enrolled

Drug Interactions1 trial

Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT04669678·110 enrolled

Efficacy and Safety1 trial

A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)(P06473)(COMPLETED)

Completed·OOrganon and Co·Phase 4·NCT00725413·210 enrolled

17 more indications

OSA1 trial

Impact of Contraceptives on Cervico-Vaginal Mucosa

Completed·—·Phase 4·NCT04814927·112 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

Immunity1 trial

Contraceptive Hormones, Immunity, and Microbiome Evaluation

Completed·EEmory University··NCT03660046·155 enrolled

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

Interaction1 trial

Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant

Unknown status·MMakerere University·Phase 2·NCT03589040·60 enrolled

Female1 trial

Body Composition and Sport Performance Among Young Female Soccer Players Using Subdermic Etonogestrel

Suspended·MMaíta Poli de Araújo·Phase 1·NCT06775626·40 enrolled

Endometrial Hyperplasia without Atypia1 trial

The Use of Etonogestrel Contraceptive Implant as Treatment for Endometrial Hyperplasia Without Atypia: A Cohort Study

Not yet recruiting·UUniversity of the Philippines··NCT06378489·60 enrolled

Endometrial1 trial

Endometrial Biopsy in Progestin Contraceptive Users

Recruiting·OOregon Health and Science University·Phase 1·NCT05760144·52 enrolled

Progesterone1 trial

Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study

Withdrawn·SSaskatchewan Health Authority - Regina Area·Phase 2·NCT05227456

Trial1 trial

Casea S Contraceptive Implants (Casea S) Trial

Active, not recruiting·FFHI 360·Phase 1·NCT05174884·20 enrolled

Dysmenorrhea1 trial

A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)

Completed·OOrganon and Co·Phase 2·NCT01670656·439 enrolled

Effectiveness1 trial

A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806)

Terminated·OOrganon and Co·Phase 2·NCT00651807·16 enrolled

Breastfeeding1 trial

Breastfeeding Etonogestrel Implant Study

Completed·UUniversity of New Mexico·Phase 4·NCT03978598·150 enrolled

Abnormal Uterine Bleeding1 trial

Abnormal Uterine Bleeding and Progestin-only Contraceptives

Completed·—··NCT03398811·390 enrolled

Endometriosis1 trial

Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Endometriosis

Completed·UUniversity of Campinas, Brazil·Phase 4·NCT02480647·100 enrolled

Systemic Lupus Erythematosus1 trial

Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus

Unknown status·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 2/3·NCT05791799·180 enrolled

Unspecified3 trials

Shoulder Contraceptive Implant Study

Completed·UUniversity of Colorado, Denver·Phase 4·NCT04463693·5 enrolled

Kuwa Free! - Live Free!

Recruiting·UUniversity of Alabama at Birmingham·N/A·NCT05044962·700 enrolled

A Pharmacokinetic Evaluation of Etonogestrel (ENG) Implant and Antiretroviral Therapy

Completed·UUniversity of Pittsburgh·Phase 4·NCT02082652·60 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 17, 2006

IMPLANON

NDA NDA021529

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for etonogestrel. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Implanon drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — etonogestrel compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for etonogestrel. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021529). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Implanon. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Progesterone Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: OOrganon and Co

Patent Landscape[6]

Patent Cliff

Aug 28, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8888745Aug 28, 2026

10821277May 31, 2027

8722037Sep 28, 2027

9757552Jul 28, 2030

Implanon

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Trials by Indication[1]

Contraception3 trials

ART2 trials

Women2 trials

Drug Interactions1 trial

Efficacy and Safety1 trial

OSA1 trial

Pregnancy1 trial

Immunity1 trial

Ovarian Function1 trial

Interaction1 trial

Female1 trial

Endometrial Hyperplasia without Atypia1 trial

Endometrial1 trial

Progesterone1 trial

Trial1 trial

Dysmenorrhea1 trial

Effectiveness1 trial

Breastfeeding1 trial

Abnormal Uterine Bleeding1 trial

Endometriosis1 trial

Systemic Lupus Erythematosus1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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