Wednesday, July 8, 2026

Drug profile · INN

levonorgestrel

levonorgestrel (KYLEENA) is a progesterone receptor agonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: implantation. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 2
Pipeline programs 14
News articles 0
Drug details — levonorgestrel
US status
approved
Class
Route
IMPLANTATION
Patents
2
Programs
14
Data quality
0.84

Quick answer

levonorgestrel (KYLEENA) is a progesterone receptor agonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: implantation. Current US regulatory status: approved.

Key facts

INN levonorgestrel
Brand KYLEENA
Mechanism Progesterone receptor agonist
Target Progesterone receptor
Route IMPLANTATION
Formulation IMPLANT

Mechanism of action

Progesterone receptor agonist

Primary target: Progesterone receptor

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg Phase 3 · Chinese Academy of · Oral Contraceptive
  2. Levonorgestrel/EE 0.15/0.03 mg and EE 0.01 mg tablets Phase 3 · Teva Pharma · Contraception
  3. Mirena 20 mikrogram/24 timmar intrauterint in... Phase 3 · George Institute for · Post medical abortion contraception
  4. Seasonale (levonorgestrel and ethinyl estradiol) Phase 3 · Teva Pharma · Osteopenia
  5. Seasonale [levonorgestrel (LNG)/ethinyl estradiol (EE)] Phase 3 · Teva Pharma · Healthy
  6. levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets Phase 3 · Teva Pharma · Dysmenorrhea
  7. 91-day Levonorgestrel Oral Contraceptive Phase 2 · Teva Pharma · Hemostasis
  8. 91-day Levonorgestrel Oral Contraceptive Phase 2 · Teva Pharma · Migraine

Related & competitor drugs

  1. desogestrel Progesterone receptor agonist
  2. medroxyprogesterone acetate Progesterone receptor agonist
  3. megestrol acetate Progesterone receptor agonist
  4. norethindrone Progesterone receptor agonist
  5. norethindrone acetate Progesterone receptor agonist
  6. progesterone Progesterone receptor agonist
  1. US 8415332

    Methods of hormonal treatment utilizing ascending-dose extended cycle regimens

    Expires Mon Apr 04 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 7855190

    Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration

    Expires Mon Dec 16 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is levonorgestrel?

levonorgestrel (KYLEENA) is a progesterone receptor agonist. Associated with Lacuna Pharma Pty Ltd. Route of administration: implantation. Current US regulatory status: approved.

What is the brand name for levonorgestrel?

KYLEENA is a marketed brand name for levonorgestrel. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of levonorgestrel?

levonorgestrel has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.