Jadelle

(Levonorgestrel)

ApprovedSmall molecule

IItalian Network for Tumor Biotherapy Foundation

Jadelle is a small molecule that works as a Progesterone Receptor Agonist.[2] It is being used across 21 indications, with its most advanced program in Approved.[1]

Jadelle is one of 472 small molecule programs targeting Contraception. It is currently in Approved.

Indications

Total Trials

Active Trials

471

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

ContraceptionNot yet recruiting

InfertilityActive, not recruiting

MetrorrhagiaActive, not recruiting

Temporomandibular Joint DisorderActive, not recruiting

Endometrial PolypActive, not recruiting

OsteoporosisActive, not recruiting

Premenstrual TensionApproved

MenorrhagiaActive, not recruiting

ObesityActive, not recruiting

DysmenorrheaActive, not recruiting

ContraceptionApproved

Not yet recruiting

InfertilityPreclinical

Active, not recruiting

MetrorrhagiaPreclinical

Active, not recruiting

Temporomandibular Joint DisorderPreclinical

Active, not recruiting

Endometrial PolypPreclinical

Active, not recruiting

OsteoporosisApproved

Active, not recruiting

Premenstrual TensionApproved

Approved

MenorrhagiaApproved

Active, not recruiting

ObesityPreclinical

Active, not recruiting

DysmenorrheaApproved

Active, not recruiting

Showing 10 of 21 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Jadelle

IItalian Network for Tumor Biotherapy Foundation

Approved

1 2

Emtriva

Gilead

Preclinical

1 3

Lamprene

Novartis

Preclinical

1 4

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 5

Theo-Dur

Pfizer

Preclinical

1 6

Foscavir

CClinigen, Inc.

Preclinical

6 7

Sirturo

WWim Janssens

Preclinical

1 8

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 9

Reminyl

WWim Janssens

Preclinical

1 10

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Treatment

NCT01686126

Q4 2027

Phase 3Not yet recruiting

Contraception

NCT06727734

Q4 2030

Phase 3Not yet recruiting

Contraceptive Usage

NCT07734155

Clinical

Trials by Indication[1]

Contraception12 trials

Efficacy Trial of CDB 2914 for Emergency Contraception

Completed·UUniversity of Pittsburgh·Phase 2/3·NCT00271583·1,672 enrolled

Pericoital Oral Contraception With Levonorgestrel

Completed·FFHI 360·Phase 3·NCT00922233·72 enrolled

Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg

Terminated·KKimberly Myer·Phase 4·NCT03537768·532 enrolled

Show 9 more trials

Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception

Not yet recruiting·TThe University of Hong Kong·Phase 3·NCT06727734·980 enrolled

The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception

Completed·UUniversity of Utah··NCT00966771·548 enrolled

Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia

Completed· Bayer logo

Bayer·Phase 4·NCT00393198·204 enrolled

Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception

Completed·UUniversity of Utah·N/A·NCT00669396·57 enrolled

Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT03819114·122 enrolled

Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception

Completed·—·Phase 2/3·NCT03614494·860 enrolled

Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception

Completed·HHRA Pharma·Phase 3·NCT00551616·2,221 enrolled

Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIV

Unknown status·BBotswana Harvard AIDS Institute Partnership·Phase 4·NCT04910711·140 enrolled

Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Completed· Pfizer logo

Pfizer·Phase 3·NCT00245921·2,000 enrolled

Acceptability3 trials

A Study on the Feasibility and Acceptability of Pericoital Levonorgestrel 1.5mg

Completed·CCamber Collective··NCT04058873·1,980 enrolled

Non-interventional Study of Long-term Intrauterine Contraceptives Acceptability and User Satisfaction

Completed· Bayer logo

Bayer··NCT01590537·2,348 enrolled

Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens

Not yet recruiting·GGynuity Health Projects·Phase 2/3·NCT06492889·286 enrolled

Oral3 trials

Effects of St. John's Wort on the Oral Contraceptive Hormone Levonorgestrel

Completed·UUniversity of Utah·Phase 4·NCT00131885·36 enrolled

Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

Completed· Bayer logo

Bayer·Phase 1·NCT01096485·24 enrolled

Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

Completed· Bayer logo

Bayer·Phase 1·NCT01096498·24 enrolled

Women2 trials

Pharmacologic Strategies to Use the Levonorgestrel Implant in HIV-infected Women

Completed·UUniversity of Nebraska·Phase 2·NCT02722421·28 enrolled

A Cross-sectional, Observational Multicenter Study to Assess the Reasons for Choosing the 3-year Hormonal IUD and Level of IUDs Knowledge Among Women Aged 18 to 29 Years

Completed· Bayer logo

Bayer··NCT02903888·886 enrolled

Interaction2 trials

Drug-drug Interaction of BI 201335 and Microgynon

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01570244·16 enrolled

Potential Drug Interaction Study Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel/Ethinyl Estradiol-containing Oral Contraceptives, and Carbamazepine

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06071442·60 enrolled

20 more indications

Menorrhagia2 trials

MiCo - Mirena or Conventional Medical Treatment for Menorrhagia

Completed· Bayer logo

Bayer··NCT01085487·1,211 enrolled

Mirena or Conventional Medical Treatment for Menorrhagia

Completed· Bayer logo

Bayer··NCT00864136·647 enrolled

ESS2 trials

Assessing Use Of Mifepristone After Progestin Priming For Use As "Missed Period Pills"

Unknown status·GGynuity Health Projects·Phase 2·NCT04676776·139 enrolled

Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men

Completed·PPremier Research·Phase 2·NCT03455075·92 enrolled

Pregnancy Prevention2 trials

A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Normal Menstruating Women

Completed·IInnovaGyn, Inc.·Phase 2·NCT05695352·19 enrolled

A Phase II Study to Evaluate the Delay in Ovulation Following Oral Levonorgestrel Plus Meloxicam Compared to Placebo in Obese But Normal Menstruating Women

Completed·IInnovaGyn, Inc.·Phase 2·NCT06306131·4 enrolled

Endometrioma1 trial

Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas

Suspended·FFundación Santa Fe de Bogota·Phase 2/3·NCT02599077·50 enrolled

Tics1 trial

Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches

Completed·AAgile Therapeutics·Phase 1/2·NCT01623466·36 enrolled

Ovarian Cancer1 trial

Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer

Completed·GGynecologic Oncology Group·Phase 2·NCT00445887·60 enrolled

Female1 trial

Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects

Completed· GSK logo

GSK·Phase 1·NCT02159131·20 enrolled

Empagliflozin1 trial

Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01328184·18 enrolled

Active Surveillance1 trial

European Active Surveillance Study (EURAS)

Completed·CCenter for Epidemiology and Health Research, Germany··NCT00302848·59,510 enrolled

Observational Study1 trial

An Observational Study to Assess Quality of Life and Satisfaction of Young Women (Aged 18-29) Following 6 (±1) Months Using Jaydess as Their Contraceptive Method

Completed· Bayer logo

Bayer··NCT02574715·1,039 enrolled

Heavy Menstrual Bleeding1 trial

Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding

Completed· Bayer logo

Bayer··NCT00874653·78 enrolled

Satisfaction1 trial

LCS16 vs. COC User Satisfaction and Tolerability Study

Completed· Bayer logo

Bayer·Phase 3·NCT03074045·145 enrolled

Drug1 trial

JAYDESS Drug Utilization Study in Sweden

Completed· Bayer logo

Bayer··NCT02349815·10,000 enrolled

Efficacy1 trial

Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women

Completed· Bayer logo

Bayer·Phase 3·NCT02403401·1,471 enrolled

Treatment1 trial

Improving the Treatment for Women With Early Stage Cancer of the Uterus

Active, not recruiting·QQueensland Centre for Gynaecological Cancer·Phase 2·NCT01686126·165 enrolled

Ovulation1 trial

Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

Completed· Pfizer logo

Pfizer·Phase 2·NCT00254189·60 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

Atorvastatin1 trial

STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS

Completed· Pfizer logo

Pfizer·Phase 1·NCT05093205·35 enrolled

Contraceptive Usage1 trial

Prospective, Multicenter, Open-label and Non-randomized Trial on Contraceptive Efficacy, Safety and Tolerability of LVS (Levonorgestrel Vaginal System) During 13 Cycles

Not yet recruiting·CChemo Research·Phase 3·NCT07734155·1,600 enrolled

Unspecified4 trials

Kuwa Free! - Live Free!

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

A Pharmacokinetic Evaluation of Levonorgestrel Implant and Antiretroviral Therapy

Completed·UUniversity of Nebraska·Phase 2·NCT01789879·60 enrolled

Bay98-7196, Dose Finding / POC Study

Completed· Bayer logo

Bayer·Phase 2·NCT02203331·319 enrolled

Show 1 more trial

Mirena Observational Program

Completed· Bayer logo

Bayer··NCT00883662·2,725 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 10, 1990

NORPLANT SYSTEM IN PLASTIC CONTAINER

NDA NDA020088

Dec 10, 1990

NORPLANT

NDA NDA019897

Aug 15, 1996

LEVONORGESTREL

NDA NDA020627

Nov 1, 1996

JADELLE

NDA NDA020544

Jul 28, 1999

PLAN B

NDA NDA021045

Dec 6, 2000

MIRENA

NDA NDA021225

Jul 10, 2009

PLAN B ONE-STEP

NDA NDA021998

Jan 9, 2013

SKYLA

NDA NDA203159

Feb 26, 2015

LILETTA

NDA NDA206229

Sep 16, 2016

KYLEENA

NDA NDA208224

Sources

References

[1]
ClinicalTrials.gov — 48 trial records for Levonorgestrel. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Levonorgestrel compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Levonorgestrel. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208224). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Jadelle. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Italian Network for Tumor Biotherapy Foundation company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Progesterone Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: IItalian Network for Tumor Biotherapy Foundation

Patent Landscape[5]

Patent Cliff

Feb 7, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11628088Feb 7, 2027

11850182Sep 14, 2029

10561524Sep 16, 2029

12004992Oct 6, 2033

11090186Oct 24, 2033

2 more patents

10028858Mar 22, 2034

11571328Sep 7, 2040

Jadelle

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q4 2030

Trials by Indication[1]

Contraception12 trials

Acceptability3 trials

Oral3 trials

Women2 trials

Interaction2 trials

Menorrhagia2 trials

ESS2 trials

Pregnancy Prevention2 trials

Endometrioma1 trial

Tics1 trial

Ovarian Cancer1 trial

Female1 trial

Empagliflozin1 trial

Active Surveillance1 trial

Observational Study1 trial

Heavy Menstrual Bleeding1 trial

Satisfaction1 trial

Drug1 trial

Efficacy1 trial

Treatment1 trial

Ovulation1 trial

Endometriosis1 trial

Atorvastatin1 trial

Contraceptive Usage1 trial

Unspecified4 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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