Uterine fibroids - Pipeline Insight, 2024

This “Uterine fibroids - Pipeline Insight, 2024,” report provides comprehensive insights about 25+ companies and 25+ pipeline drugs in Uterine fibroids pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Uterine fibroids Understanding

Uterine fibroids: Overview

Uterine fibroids are benign (not cancer) growths that develop from the muscle tissue of the uterus. They also are called leiomyomas or myomas. The size, shape, and location of fibroids can vary greatly. They may be inside the uterus, on its outer surface or within its wall, or attached to it by a stem-like structure. A woman may have only one fibroid or many of varying sizes. A fibroid may remain very small for a long time and suddenly grow rapidly, or grow slowly over a number of years. Fibroids are most common in women aged 30-40 years, but they can occur at any age. Fibroids occur more often in African American women than in white women. They also seem to occur at a younger age and grow more quickly in African American women
Symptoms
Fibroids may have the following symptoms:

• Changes in menstruation
• Longer, more frequent, or heavy menstrual periods
• Menstrual pain (cramps)
• Vaginal bleeding at times other than menstruation
• Anemia (from blood loss)
• Pain
• In the abdomen or lower back (often dull, heavy and aching, but may be sharp)
• During sex
• Pressure
• Difficulty urinating or frequent urination
• Constipation, rectal pain, or difficult bowel movements
• Abdominal cramps
• Enlarged uterus and abdomen
• Miscarriages
• Infertility

Fibroids also may cause no symptoms at all. Fibroids may be found during a routine pelvic exam or during tests for other problems
Diagnosis
The first signs of fibroids may be detected during a routine pelvic exam. A number of tests may show more information about fibroids:

• Ultrasonography uses sound waves to create a picture of the uterus and other pelvic organs.
• Hysteroscopy uses a slender device (the hysteroscope) to see the inside of the uterus. It is inserted through the vagina and cervix (opening of the uterus). This lets your health care professional see fibroids inside the uterine cavity.
• Hysterosalpingography is a special X-ray test. It may detect abnormal changes in the size and shape of the uterus and fallopian tubes.
• Sonohysterography is a test in which fluid is put into the uterus through the cervix. Ultrasonography is then used to show the inside of the uterus. The fluid provides a clear picture of the uterine lining.
• Laparoscopy uses a slender device (the laparoscope) to help your health care professional see the inside of the abdomen. It is inserted through a small cut just below or through the navel. Fibroids on the outside of the uterus can be seen with the laparoscope.

Treatment
Drug therapy is an option for some women with fibroids. Medications may reduce the heavy bleeding and painful periods that fibroids sometimes cause. They may not prevent the growth of fibroids. Surgery often is needed later. Drug treatment for fibroids includes the following options:

• Birth control pills and other types of hormonal birth control methods - These drugs often are used to control heavy bleeding and painful periods.
• Gonadotropin-releasing hormone (Gn RH) agonists - These drugs stop the menstrual cycle and can shrink fibroids. They sometimes are used before surgery to reduce the risk of bleeding. Because GnRH agonists have many side effects, they are used only for short periods (less than 6 months). After a woman stops taking a GnRH agonist, her fibroids usually return to their previoussize.
• Progestin-releasing intrauterine device (IUD) - This option is for women with fibroids that do not distort the inside of the uterus. It reduces heavy and painful bleeding but does not treat the fibroids themselves.

Uterine fibroids Emerging Drugs Chapters

This segment of the Uterine fibroids report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Uterine fibroids Emerging Drugs

Linzagolix: Kissei Pharmaceutical Linzagolix is a novel, orally administered Gn RH (gonadotropin releasing hormone) receptor antagonist. Linzagolix acts by binding to and blocking the GnRH receptor in the pituitary gland, ultimately reducing estrogen production by the ovaries. It is currently in phase III stageofdevelopment.

Relugolix: Myovant Sciences Relugolix is a small molecule, gonadotropin-releasing hormone (Gn RH) receptor antagonist, and an oral investigational drug candidate for the treatment of uterine fibroids, endometriosis, and advanced prostate cancer. As a GnRH receptor antagonist, relugolix binds to and blocks the GnRH receptor (Gn RHR) in the anterior pituitary gland.Blocking GnRH receptors decreases the release of gonadotropins - luteinizing hormone (LH) and follicle-stimulating hormone (FSH) - thereby decreasing the downstream production of estrogen and progesterone by the ovaries in women and testosterone by thetestesinmen.

Fezolinetant: Ogeda Fezolinetant is being investigated as a superior option to gonadotropin-releasing hormone (Gn RH) products as fezolinetant reduces levels of the ovarian hormones estrogen and progesterone, but in a non-castrating manner, as would be required for the safe, effective, chronic treatment of uterine fibroids and endometriosis. It is in phase II stageofdevelopment.

Uterine fibroids: Therapeutic Assessment

This segment of the report provides insights about the different Uterine fibroids drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Uterine fibroids

There are approx. 25+ key companies which are developing the therapies for Uterine fibroids. The companies which have their Uterine fibroids drug candidates in the most advanced stage, i.e. phase III include Kissei Pharmaceutical and others

Phases

This report covers around 25+ products under different phases of clinical development like

• Late-stage products (Phase II and Phase II/III)
• Mid-stage products (Phase II and Phase II/III)
• Early-stage products (Phase I/II and Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Uterine fibroids pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Infusion
• Intradermal
• Intramuscular
• Intranasal
• Intravaginal
• Oral
• Parenteral
• Subcutaneous
• Topical.

Molecule Type

Products have been categorized under various Molecule types such as

• Gene therapies
• Small molecule
• Vaccines
• Polymers
• Peptides
• Monoclonal antibodies

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Uterine fibroids: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Uterine fibroids therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Uterine fibroids drugs.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Uterine fibroids R&D. The therapies under development are focused on novel approaches to treat/improve Uterine fibroids.

• In December 2019, Kissei Pharmaceutical announced that ObsEva SA reported positive 24-week results from the PRIMROSE 2 phase-III clinical trial of linzagolix for the treatment of uterine fibroids.
• Vilaprisan (BAY1002670) is an investigational therapy by Bayer Health Care Pharmaceuticals that may no longer be in development to treat endometriosis and uterine fibroids. The company announced in December 2018 that it was halting trials of vilaprisan after long-term toxicology studies in rodents indicated a potentialproblem.
• In June 2020, Myovant Sciences announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its once-daily relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with heavy menstrual bleeding associated with uterine fibroids.

Uterine fibroids Report Insights

• Uterine fibroids Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Uterine fibroids Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Uterine fibroids drugs?
• How many Uterine fibroids drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Uterine fibroids?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Uterine fibroids therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Uterine fibroids and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• AbbVie Inc
• Addex Therapeutics Ltd
• Bayer AG
• Bio Specifics TechnologiesCorp
• Dongkook Pharmaceutical Co Ltd
• Kissei Pharmaceutical Co Ltd
• Myovant Sciences
• Ogeda SA
• Repros Therapeutics Inc
• Takeda Pharmaceutical Company Ltd

Key Products

• Linzagolix
• Relugolix:
• Fezolinetant
• CFI 400945
• CTX 030916
• Fezolinetant
• Vilaprisan
• Proellex
• Leuprorelin
• Ulipristal Acetate
• PGL4001