Hormones and Trials - Clinical Research Informer

Certain menopausal hormone therapy could raise ovarian cancer risk, study finds

Bio Pharma Dive

MAY 23, 2024

The findings, from two trials involving tens of thousands of women, could influence guidelines around the use of hormonal treatment for menopausal symptoms.

Hormones

Hormones Trials

New male contraceptive does not involve hormones

Medical Xpress

NOVEMBER 24, 2022

Instead of using hormones to disrupt sperm production, the new technique involves placing a hydrogel called ADAM into the vas deferens to prevent sperm from making its way to the urethra.

Hormones

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Neurocrine Biosciences’ Crenessity Approved as First New Treatment in Decades for Rare Genetic Disorder CAH

XTalks

DECEMBER 18, 2024

CAH is a group of rare genetic disorders affecting the adrenal glands, which produce essential hormones like cortisol, aldosterone and androgens. The most common form of CAH, 21-hydroxylase deficiency, disrupts hormone production, leading to cortisol deficiency and an overproduction of androgens.

Genetics

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Eneboparatide Advances in Hypoparathyroidism Trial: Key Phase III Update

XTalks

MARCH 19, 2025

Eneboparatide (AZP-3601), an investigational parathyroid hormone 1 receptor (PTH1R) agonist, met its primary endpoint in the CALYPSO Phase III trial, offering new data for adults with chronic hypoparathyroidism. AstraZeneca received eneboparatide during its $1.05

Trials

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New ‘Mechanical’ Weight Loss Pill from Oxford Medical Products Shows Positive Safety Data

XTalks

OCTOBER 23, 2024

Unlike drugs that alter metabolism or appetite by interacting with hormones, the pill functions entirely mechanically. In Oxford Medical’s first-in-human trials, conducted in a diverse patient group, data shows that the pill is well-tolerated, with no significant adverse events reported.

Production

Production Hormones Drugs Trials

Alzheimer’s Is More Common in Women, And This May Help Explain Why

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 9, 2024

Now two new studies raise the possibility of complex interactions between hormones and […] In the US, roughly two out of every three people with Alzheimer’s is a woman, a statistic that could be partially explained by the fact women typically live longer than men. Yet researchers have suspected there could be more to the story.

Hormones

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For The First Time, Scientists Showed Structural, Brain-Wide Changes During Menstruation

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 24, 2024

The constant ebb and flow of hormones that guide the menstrual cycle don’t just affect reproductive anatomy. They also reshape the brain, and a study has given us insight into how this happens.

Scientist

Scientist Hormones Research Clinical Trials

Ibutamoren mesylate by Lumos Pharma for Growth Hormone Deficiency: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 9, 2023

Ibutamoren mesylate is under clinical development by Lumos Pharma and currently in Phase II for Growth Hormone Deficiency. According to GlobalData, Phase II drugs for Growth Hormone Deficiency have a 63% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. It is administered orally.

Hormones

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New Breakthrough Points to a Future Treatment For Morning Sickness

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 17, 2023

New research by our team has identified sensitivity to a hormone made in abundance by the developing pregnancy, GDF15, […] Sickness in pregnancy, or hyperemesis gravidarum, is common and is thought to affect seven out of ten women at some time in their pregnancy. But, until recently, very little has been known about why it happens.

Hormones

Hormones Research Development Clinical Trials

There’s An Easier Way to Take Insulin, But It Hasn’t Been Tested on People Yet

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 9, 2022

Millions around the world must inject the crucial hormone underneath their skin several times a day to keep their glucose levels in balance. The most effective way for people with diabetes to deliver insulin is also incredibly intrusive.

Insulin

Insulin Hormones Scientist Clinical Trials

The US Just Approved The First Over-The-Counter Daily Birth Control Pill

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 17, 2023

The pill, called Opill – the brand name for the tablet formulation of norgestrel – is an oral contraceptive containing only progestin hormone, which helps prevent pregnancy […]

Hormones

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Pfizer and OPKO's Growth Hormone Drug Effective in Late-Stage Trial

BioSpace

OCTOBER 7, 2020

Pfizer and Opko Health reported their Phase III clinical trial of somatrogan met the primary endpoint compared to Genotropin (somatropin) for treating children 3 to 18 years of age with growth hormone deficiency.

Hormones

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Sling Therapeutics’s Linsitinib Meets Primary Endpoint in Thyroid Eye Disease Trial, Eyes Competition with Amgen’s Tepezza

XTalks

JANUARY 16, 2025

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). Ninety patients in the trial were randomized to receive one of two doses of linsitinib or placebo.

Trials

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Merck and Orion enter partnership to develop ODM-208 for prostate cancer

Pharmaceutical Technology

JULY 13, 2022

Orion discovered and developed ODM-208 to treat hormone-dependent cancers, such as prostate cancer. An oral, non-steroidal and selective CYP11A1 inhibitor, ODM-208 is currently being analysed in a Phase II trial in mCRPC patients. As per the agreement, the companies will jointly develop and market ODM-208.

Development

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AstraZeneca and MSD’s Lynparza combo bags FDA approval for prostate cancer

Pharmaceutical Technology

JUNE 1, 2023

On 31 May, the FDA granted approval based on subgroup analysis of the Phase III PROpel trial (NCT03732820) in patients with BRCA mutations. Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines. Trials peaked at 115 in 2018 before declining to 91 last year.

FDA Approval

FDA Approval Hormones Trials Clinical Trials

Doctor Reveals What Happens When You Stop Taking Ozempic

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 23, 2024

Semaglutide (sold as Wegovy and Ozempic) and tirzepatide (sold as Zepbound and Mounjaro) are the most well known in the class of drugs that mimic hormones to reduce feelings of hunger. Drugs like Ozempic are very effective at helping most people who take them lose weight. But does weight come back when you stop using […]

Doctor

Doctor Doctors Hormones Drugs

FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Pharmaceutical Technology

JUNE 13, 2023

The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen.

HR

HR Hormones Trials Protein

Bayer eyes Nubeqa’s label expansion in prostate cancer following Phase III win

Pharmaceutical Technology

JULY 18, 2024

The Phase III trial evaluating Nubeqa in patients with metastatic hormone-sensitive prostate cancer met its primary endpoint.

Hormones

Hormones Trials

AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. months compared with 5.1 months for the chemotherapy arm. months compared with 16.8

FDA Approval

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Novartis’ radioligand therapy meets phase 3 prostate cancer trial target

pharmaphorum

MARCH 23, 2021

That’s looking increasingly likely thanks to the trial data just announced, which shows the drug significantly improved overall and progression-free survival compared with standard care in PSMA-positive metastatic castration-resistant prostate cancer. The five-year survival rate for patients with mCRPC is approximately 15%.

Trials

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Keytruda fluffs its lines in prostate, liver cancer trials

pharmaphorum

AUGUST 4, 2022

Two phase 3 trials of Merck & Co’s Keytruda in metastatic castration-resistant prostate cancer (CRPC) and advanced liver cancer have ended in failure, proving once again that cancer immunotherapy studies can be a hit-and-miss affair. The post Keytruda fluffs its lines in prostate, liver cancer trials appeared first on.

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Syncing Menstrual Cycles With Workouts May Help With Fitness, If You Can Do It

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 14, 2022

If you’re someone who has to deal with a period regularly, you’re probably all too familiar with just how much your energy levels can change throughout your cycle thanks to hormonal fluctuations.

Hormones

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US FDA grants approval for Orion-Bayer’s Nubeqa combo for prostate cancer

Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for a supplemental New Drug Application (sNDA) of Orion and its partner Bayer ’s Nubeqa (darolutamide) plus docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients. in trial subjects versus those who received ADT plus docetaxel.

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New hormonal agent may slow progression of early-stage prostate cancer during active surveillance

Medical Xpress

JANUARY 10, 2023

For men with early-stage prostate cancer being managed by active surveillance, adding the hormonal agent apalutamide may lower the rate of positive biopsies during follow-up, suggests a preliminary clinical trial in the Journal of Urology.

Hormones

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Bayer extends elinzanetant trials to include breast cancer

pharmaphorum

OCTOBER 17, 2022

Bayer has added another clinical trial to its extensive phase 3 programme for oral neurokinin antagonist elinzanetant, hoping to show that it can treat vasomotor symptoms (VMS) in breast cancer patients. The post Bayer extends elinzanetant trials to include breast cancer appeared first on. There are around 2.3

Trials

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Adding capivasertib to fulvestrant improves progression-free survival of hormone receptor-positive breast cancer

Medical Xpress

DECEMBER 8, 2022

In patients with hormone receptor (HR)-positive, HER2-negative tumors resistant to aromatase inhibitors, addition of the investigational AKT inhibitor capivasertib to fulvestrant (Faslodex) doubled the median progression-free survival compared with placebo plus fulvestrant in the phase III CAPItello-291 clinical trial, according to results presented (..)

Hormones

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Quest and Proov collaborate to bring novel home fertility test to women through questhealth.com

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 10, 2023

Available through a collaboration with the consumer-initiated testing business of Quest Diagnostics and Proov, maker of at-home fertility and hormone tests, the Proov Confirm PdG test is the first and only FDA-cleared […]

Hormones

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Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

JULY 8, 2022

The company claimed that the utmost benefit is reported in hormone-receptor positive (HR+) women and those who commence treatment with Nerlynx within a year of receiving trastuzumab-based therapy. In a Phase III ExteNET clinical trial, neratinib offered a 34% decline in the risk of recurrence and a 2.3%

FDA Approval

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Camizestrant may be superior to fulvestrant in patients with hormone receptor-positive, HER2-negative breast cancer

Medical Xpress

DECEMBER 8, 2022

The next-generation selective estrogen receptor degrader (SERD) camizestrant improved progression-free survival, compared with fulvestrant (Faslodex), in patients with hormone receptor-positive, HER2-negative breast cancer in the phase II SERENA-2 trial, according to results presented at the San Antonio Breast Cancer Symposium, held December 6-10, (..)

Hormones

Hormones Trials

Bayer’s Nubeqa, en route to blockbusterland, clinches 2nd win in prostate cancer subtype

Fierce Pharma

JULY 17, 2024

Bayer has claimed a second pivotal trial win for its blockbuster-to-be androgen receptor inhibitor Nubeqa, looking to reach the entire space of metastatic hormone-sensitive prostate cancer (mHSPC).

Hormones

Hormones Trials

(LAI-287 + semaglutide) by Novo Nordisk for Type 2 Diabetes: Likelihood of Approval

Pharmaceutical Technology

FEBRUARY 24, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It focuses on advancing drugs for the treatment of diabetes and other serious chronic conditions, including hemophilia, human growth hormone (HGH) disorders, rare blood and rare endocrine diseases, and obesity.

Insulin

Insulin Hormones Drugs Clinical Trials

Povorcitinib Phase III Results Stir Mixed Signals for Incyte and Investors

XTalks

MARCH 18, 2025

Incytes recent announcement on the topline results from two Phase III clinical trials of povorcitinib in patients with hidradenitis suppurativa has stirred both hope and caution in the market. These promising figures had set high expectations for subsequent trials. The other Phase III trial, STOP-HS2, showed a 42.3% for placebo.

Trials

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Trial sets up wider use of Bayer's Nubeqa in prostate cancer

pharmaphorum

JULY 17, 2024

Bayer has the result it was hoping for in the phase 3 ARANOTE trial of Nubeqa in metastatic, hormone-sensitive prostate cancer (mHSPC), a key part of its plan to build the drug into a €3 billion-a-year blockbuster.ARANOTE compared Nubeqa (darolutamide) to placebo given with standard androgen deprivation therapy (ADT) and showed a significant improvement (..)

Radiology

Radiology Trials Hormones Drugs

Roche Invests $5.3B in Zealand’s Petrelintide, an Obesity Drug Candidate

XTalks

MARCH 17, 2025

billion, primarily linked to initiating Phase III trials for petrelintide as a stand-alone therapy, with sales-based milestones that could push the total value to $5.3 Amylin, a hormone co-secreted with insulin, plays a key role in regulating appetite by enhancing leptins effects the hormone that signals fullness after eating.

Hormones

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Obesity-Focused Metsera Launches IPO Amid Much Anticipation

XTalks

FEBRUARY 5, 2025

a clinical-stage biotech company focused on developing next-gen injectable and oral nutrient-stimulated hormone (NuSH) analog peptides for the treatment of obesity, overweight and related conditions, has priced its initial public offering (IPO) at $18.00 If successful, Phase III trials are expected to follow shortly thereafter.

Hormones

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Eli Lilly’s Tirzepatide Shows Promise for Keeping Prediabetic Patients Diabetes-Free

XTalks

NOVEMBER 21, 2024

These gut hormones are released in response to nutrient intake and play a crucial role in the incretin effect, which enhances insulin secretion. Participants were selected based on their prediabetic status, and the trial compared tirzepatide with a placebo.

Sales

Sales Insulin Drugs Trials

Big day for AZ, Daiichi as Enhertu aces HER2-low breast cancer trial

pharmaphorum

FEBRUARY 21, 2022

In contrast, up to 55% of all patients with breast cancer have tumours with a HER2-low score, as defined in the DESTINY-Breast04 trial, and approval in this group could unlock $3 billion in additional sales for Enhertu, according to analysts at Credit Suisse. AZ paid a hefty $1.4 AZ paid a hefty $1.4

Trials

Trials Sales Hormones Drugs

Non-hormonal therapy reduces hot flashes and night sweats in women who have been diagnosed with breast cancer

Medical Xpress

NOVEMBER 11, 2022

A Monash University-led trial of a new drug known as Q-122 therapy significantly reduced the number and severity of hot flashes and night sweats in women who have been diagnosed with breast cancer. It also improved their sleep and had no serious adverse effects.

Hormones

Hormones Trials Drugs

NICE rejects J&J’s prostate cancer drug Erleada in initial guidance

pharmaphorum

MAY 20, 2021

NICE has rejected Johnson & Johnson’s oral prostate cancer drug Erleada (apalutamide) in patients with hormone-relapsed or hormone sensitive disease in first draft guidance. Hormone relapsed disease has stopped responding to hormone therapy and is usually treated with ADT alone or with Bayer’s Nubeqa (darolutamide) and ADT.

Hormones

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Aardvark Therapeutics IPO Sets Sights on Satiating Hyperphagia and Extreme Hunger

XTalks

FEBRUARY 21, 2025

In the gut, these receptors prompt the release of hormones such as cholecystokinin and GLP-1, which together signal satiety. In a Phase II trial involving patients with hyperphagia, ARD-101 was well tolerated and achieved an approximate eight-point reduction in hunger scores. The competitive landscape is equally dynamic.

Genetics

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Trial closes gap between Bayer’s Nubeqa and rivals in prostate cancer

pharmaphorum

DECEMBER 3, 2021

Just released results from the ARASENS trial show that adding Nubeqa (darolutamide) to docetaxel chemotherapy and androgen deprivation therapy (ADT) to switch off testosterone production helps men with castration-sensitive prostate cancer (CSPC).

Trials

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FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer

The Pharma Data

DECEMBER 21, 2020

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. MONDAY, Dec. Food and Drug Administration announced Friday.

Hormones

Hormones FDA Approval Trials Drugs

Camurus Shares Positive Phase III Results from Acromegaly Trial

XTalks

JULY 17, 2024

Sweden-based biotech Camurus shared positive Phase III trial data for CAM2029, one of its lead candidates, in patients with the rare hormonal disorder acromegaly. Due to its ability to mimic somatostatin, octreotide is used to treat various conditions associated with excessive hormone production.

Trials

Trials Hormones Clinical Trials Clinical Trials

Florida doctors' board tightens ban on gender-affirming care

Medical Xpress

FEBRUARY 10, 2023

A prohibition against puberty blocking hormones and gender-affirming surgeries for minors in Florida was tightened further after a board overseeing doctors eliminated an exception for clinical trials Friday at the request of Florida Gov. Ron DeSantis' administration.

Doctor

Doctor Doctors Hormones Clinical Trials

Certain menopausal hormone therapy could raise ovarian cancer risk, study finds

New male contraceptive does not involve hormones

Webinars

Trending Sources

Neurocrine Biosciences’ Crenessity Approved as First New Treatment in Decades for Rare Genetic Disorder CAH

Webinars

Eneboparatide Advances in Hypoparathyroidism Trial: Key Phase III Update

New ‘Mechanical’ Weight Loss Pill from Oxford Medical Products Shows Positive Safety Data

Alzheimer’s Is More Common in Women, And This May Help Explain Why

For The First Time, Scientists Showed Structural, Brain-Wide Changes During Menstruation

Ibutamoren mesylate by Lumos Pharma for Growth Hormone Deficiency: Likelihood of Approval

New Breakthrough Points to a Future Treatment For Morning Sickness

There’s An Easier Way to Take Insulin, But It Hasn’t Been Tested on People Yet

The US Just Approved The First Over-The-Counter Daily Birth Control Pill

Pfizer and OPKO's Growth Hormone Drug Effective in Late-Stage Trial

Sling Therapeutics’s Linsitinib Meets Primary Endpoint in Thyroid Eye Disease Trial, Eyes Competition with Amgen’s Tepezza

Merck and Orion enter partnership to develop ODM-208 for prostate cancer

AstraZeneca and MSD’s Lynparza combo bags FDA approval for prostate cancer

Doctor Reveals What Happens When You Stop Taking Ozempic

FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Bayer eyes Nubeqa’s label expansion in prostate cancer following Phase III win

AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Novartis’ radioligand therapy meets phase 3 prostate cancer trial target

Keytruda fluffs its lines in prostate, liver cancer trials

Syncing Menstrual Cycles With Workouts May Help With Fitness, If You Can Do It

US FDA grants approval for Orion-Bayer’s Nubeqa combo for prostate cancer

New hormonal agent may slow progression of early-stage prostate cancer during active surveillance

Bayer extends elinzanetant trials to include breast cancer

Adding capivasertib to fulvestrant improves progression-free survival of hormone receptor-positive breast cancer

Quest and Proov collaborate to bring novel home fertility test to women through questhealth.com

Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Camizestrant may be superior to fulvestrant in patients with hormone receptor-positive, HER2-negative breast cancer

Bayer’s Nubeqa, en route to blockbusterland, clinches 2nd win in prostate cancer subtype

(LAI-287 + semaglutide) by Novo Nordisk for Type 2 Diabetes: Likelihood of Approval

Povorcitinib Phase III Results Stir Mixed Signals for Incyte and Investors

Trial sets up wider use of Bayer's Nubeqa in prostate cancer

Roche Invests $5.3B in Zealand’s Petrelintide, an Obesity Drug Candidate

Obesity-Focused Metsera Launches IPO Amid Much Anticipation

Eli Lilly’s Tirzepatide Shows Promise for Keeping Prediabetic Patients Diabetes-Free

Big day for AZ, Daiichi as Enhertu aces HER2-low breast cancer trial

Non-hormonal therapy reduces hot flashes and night sweats in women who have been diagnosed with breast cancer

NICE rejects J&J’s prostate cancer drug Erleada in initial guidance

Aardvark Therapeutics IPO Sets Sights on Satiating Hyperphagia and Extreme Hunger

Trial closes gap between Bayer’s Nubeqa and rivals in prostate cancer

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer

Camurus Shares Positive Phase III Results from Acromegaly Trial

Florida doctors' board tightens ban on gender-affirming care

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