Full Press Release Details
Isabel Kalofonos Chief Commercial Officer, Crinetics Pharmaceuticals
For years, people living with acromegaly have navigated a care landscape that has remained largely unchanged. Often marked by a large treatment burden, managing treatment for the disease can feel just as demanding as the condition itself. At Crinetics, we believe patients deserve better. Today, with the approval of our first therapy, we are ready to help change what progress looks like.
The opportunity to enable people with acromegaly to gain consistent control of their disease and how they manage it is why I joined Crinetics. The challenges this community faces to live their lives to the fullest are significant, and I admire their perseverance and courage in the face of that. For many, the pain of large injections, frequent clinic visits, or break-through symptoms in between monthly injections could make their current treatment suboptimal. Barriers to accessing high-quality healthcare also are common, such as waiting several months to get an appointment with an endocrinologist, owing to geographic and other barriers. This is why, for more than a decade, Crinetics has partnered with the acromegaly community and put their voices at the front-and-center of our development program. Ultimately, our collaboration with patients has resulted in a once-daily oral option that is designed to be effective.
We believe true progress requires more than advances in the lab. It demands solutions that reach patients in ways that are meaningful and sustainable. That means elevating the standard of care by addressing not only biochemical control, but also symptom burden. It means reducing barriers, supporting providers and their patients, and creating infrastructure that makes care more accessible.
This moment is just the beginning. It reflects the foundation of a broader mission: to redefine what’s possible in endocrinology, to elevate the standard of care, and to never stop asking what meaningful progress looks like for patients. We are ready to earn that place.
What is PALSONIFY?
• PALSONIFY is a prescription medicine used to treat adults with acromegaly for whom surgery was not effective or surgery is not an option.
• It is not known if PALSONIFY is safe and effective in children
IMPORTANT SAFETY INFORMATION
What should I tell my healthcare provider before taking PALSONIFY?
Before taking PALSONIFY, tell your healthcare provider about all your medical conditions, including if you:
• have gallbladder problems
• have blood sugar control problems (low blood sugar or high blood sugar)
• have problems with low heart rate
• are pregnant or plan to become pregnant. It is not known if PALSONIFY will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if PALSONIFY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take PALSONIFY.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PALSONIFY may affect the way other medicines work, and other medicines may affect how PALSONIFY works.
Especially tell your healthcare provider if you take any medicines that can slow the heart rate.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
What are the possible side effects of PALSONIFY?
PALSONIFY may cause serious side effects including:
• Gallbladder problems: PALSONIFY may cause problems with the gallbladder. Tell your healthcare provider if you have sudden pain in the upper right area of your stomach (abdomen), sudden pain in your right shoulder or between your shoulder blades, yellowing of your skin or the whites of your eyes, or pale stools.
• Blood sugar problems: PALSONIFY may change hormone levels, potentially causing either high blood sugar (hyperglycemia), including diabetes, or low blood sugar (hypoglycemia). Tell your healthcare provider if you have problems with high or low blood sugar. Your healthcare provider will check your blood sugar when you start taking PALSONIFY or when your dose is changed.
• Heart rate problems: Tell your healthcare provider if your heart is not beating normally.
• Thyroid problems: PALSONIFY may keep your thyroid from releasing thyroid hormones, leading to hypothyroidism. Your thyroid function may be checked periodically during your treatment with PALSONIFY.
• Fatty stools: PALSONIFY may cause your body to have problems with absorbing dietary fats. Tell your healthcare provider if you have any new or worsening symptoms, including fatty stools, changes in the color of your stools, loose stools, stomach (abdominal) bloating, or weight loss.
• Low vitamin B 12 levels in your blood: Your healthcare provider may check your vitamin B 12 levels during treatment with PALSONIFY.
The most common side effects of PALSONIFY include diarrhea, pain in your stomach (abdominal) area, nausea and vomiting, decreased appetite, slow heart rate (bradycardia), high blood sugar levels (hyperglycemia), and irregular heartbeat (palpitations).
These are not all the possible side effects of PALSONIFY. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects to Crinetics Pharmaceuticals at 1-833-CRN-INFO (1-833-276-4636) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Please see Full Prescribing Information , including Patient Information , and talk to your doctor.