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Levonorgestrel

Alternative Names: levonorgestrel, bay86-5028, bay 86-5028, levogel, levosert, lng-ius, jaydess, kyleena, morning after, lng-20, lng20, lng 20, mirena, liletta, athentia next, fallback solo, opcicon one-step, norplant, norplant system in plastic container, her style, new day, econtra ez, econtra one-step, my choice tm, postday one-step, my way, afterpill, afterplan, option 2, twirla, fayosim, dolishale, iclevia, loseasonique, balcoltra, daysee, simpesse, marlissa, orsythia, seasonique, levonest, ashlyna, jaimiess, introvale, quartette, ayuna, falmina, lo simpesse, setlakin, kurvelo, afirmelle, tyblume, altavera, lybrel, lessina-21, seasonale, enpresse-21, trivora-21, myzilra, levlite, aviane-28, triphasil-28, quasense, vienva, alesse, enpresse-28, cerinta, sylevia, portia-21, trivora-28, levora 0.15/30-21, lessina-28, levora 0.15/30-28, preven emergency contraceptive kit, aviane-21, triphasil-21, elifemme, portia-28, aubra, chateal, aubra eq, amethyst, chateal eq, aviane, lessina, portia, lutera, larissia, lillow, amethia, vienva tm, sronyx, levora, trivora, enpresse, lojaimiess
Latest Update: 2024-12-14
Latest Update Note: Clinical Trial Update

Product Description

Levonorgestrel, also known as the morning-after pill, is a first-line oral emergency contraceptive pill with approval from the World Health Organization to prevent pregnancy. It is FDA-approved to be used within 72 hours of unprotected sexual intercourse or when a presumed contraceptive failure has occurred.  (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK539737/)

Mechanisms of Action: PR Agonist

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: None *

Approval Status: Approved

Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam

Approved Indications: Pregnancy Outcomes | Pregnancy Outcomes | Pregnancy Outcomes | Contraception | Pregnancy Outcomes | Injuries/wounds Unspecified | Pregnancy Outcomes | Contraception | Pregnancy Outcomes | Pregnancy Outcomes | Pregnancy Outcomes | Pregnancy Outcomes

Known Adverse Events: Abdominal Pain | Headache | Pain Unspecified | Vaginitis | Vulvovaginitis | Pelvic Pain | Injuries/wounds Unspecified | Dizziness | Leukorrhea | Migraine Disorders | Labor Pain | Spasm | Abortion, Septic | Pelvic Infection | Shock, Septic | Breast Cyst | Ovarian Cysts | Uterine Perforation | Pregnancy Outcomes | Obstetric Labor, Premature | Pregnancy, Abdominal | Pregnancy, Ectopic | Pregnancy, Ovarian | Acute Pain | Neuromyelitis Optica | Drug Hypersensitivity | Streptococcal Infections | Breast Cancer | Cervical Cancer | Liver Cancer | Ovarian Cancer | Pelvic Cancer | Uterine Cancer | Oncology Unspecified | Endometritis | Uterine Cervicitis | Headache Disorders | Depressive Disorder | Metrorrhagia

Company: Elanco Animal Health
Company Location:
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Levonorgestrel

Countries in Clinic: Australia, China, Czech Republic, Germany, Hungary, India, Lithuania, Poland, Romania, Slovakia, Spain, United States, Unknown Location

Active Clinical Trial Count: 11

Highest Development Phases

Phase 3: Contraception|Migraine Disorders|Pregnancy Outcomes

Phase 1: Acute Respiratory Distress Syndrome|Healthy Volunteers|Lymphoma, Non-Hodgkin|Menopause|Pelvic Pain

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
M16-185

P1

Recruiting

Lymphoma, Non-Hodgkin

2026-03-21

WIN Study

P1

Not yet recruiting

Pelvic Pain|Contraception|Menopause

2025-10-31

LR-301

P3

Unknown Status

Pregnancy Outcomes

2024-12-24

INCB54707-111

P1

Completed

Healthy Volunteers

2024-06-07

Recent News Events

Date

Type

Title

12/04/2024

News Article

 Daré Bioscience Announces $2.5 Million Grant Funding Installment to Support Further Development of Novel Contraceptive Technology DARE-LARC1

11/07/2024

News Article

 ViiV Healthcare expands on real-world data supporting use of long-acting therapies in diverse patient populations at HIV Glasgow

08/26/2024

News Article

 Agile Therapeutics Inc. Announces Completion of Acquisition by Insud Pharma, S.L.

08/22/2024

News Article

 Verséa Health, Inc. Announces the Official Launch of Empowered Choice™ – An Affordable and Accessible Emergency Contraceptive

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