PALSONIFYâ„¢ Acromegaly Control
Crinetics presents long-term data at ENDO 2026, confirming PALSONIFYâ„¢ provides durable acromegaly control.
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Crinetics Pharmaceuticals presented two years of clinical data at the Endocrine Society's ENDO 2026 meeting in Chicago, confirming that its once-daily oral pill PALSONIFY™ (paltusotine) keeps acromegaly durably under control. The data, drawn from the PATHFNDR-1 and PATHFNDR-2 open-label extension studies, showed that 96% of patients who reached normal IGF-1 levels — the key hormone marker for acromegaly — maintained that control through month 22 of treatment, according to Financial Post.
The results also showed stable or reduced pituitary tumor volumes for up to 48 weeks, a finding that has quieted skeptics who doubted whether an oral pill could match injectable therapies on tumor control. PALSONIFY received FDA approval in September 2025 and European Commission approval in April 2026, making it the first once-daily oral therapy for acromegaly in both markets, Ottawa Sun reported.
Two Years of Data Back Up the Pill's Promise
Acromegaly is a rare disorder caused by too much growth hormone. For decades, the only real treatment has been monthly injections — large-gauge needles that many patients find painful and dreaded. PALSONIFY works differently. It is a small-molecule pill taken once a day, and the new data confirms it keeps IGF-1 levels low and symptoms stable over the long term, according to Edmonton Sun.
Dr. Alan Krasner, Crinetics' Chief Endocrinologist, said at ENDO 2026 that "palsonify is well tolerated and maintains control of all three aspects of disease control — IGF-1 levels, symptoms, and tumor stabilization — with long-term follow-up." A subset of patients in the pooled data even saw tumor volumes shrink by more than 20%, Fort McMurray Today reported.
A Decades-Old Standard Finally Gets a Real Challenger
The go-to treatments for acromegaly since the 1990s have been injectable drugs called somatostatin receptor ligands — brands like Sandostatin LAR and Somatuline Depot. They work, but roughly 60–80% of patients experience symptom flare-ups toward the end of each 28-day injection cycle. The injections also leave bruising and painful tissue nodules, Chatham Daily News noted.
An oral option called Mycapssa reached the market in 2020, but it required twice-daily dosing and strict dietary restrictions. PALSONIFY is the first non-peptide small molecule in the class, which means it absorbs more reliably and only needs to be taken once a day. External experts have called oral options like paltusotine "excellent for patients" because they eliminate painful, large-bore needle injections entirely, according to Daily Herald Tribune.
Commercial Momentum Builds as Revenue Doubles
PALSONIFY launched commercially in late 2025. Preliminary Q4 2025 net product revenue topped $5 million. By Q1 2026, that figure doubled to $10.3 million, with 232 new patient enrollment forms submitted in the quarter alone, Sudbury Star reported. Analysts at firms including Cantor Fitzgerald, Goldman Sachs, and Jefferies have called the drug's potential "paradigm-shifting" and project it could one day surpass $1 billion in annual sales.
To accelerate adoption, Crinetics launched its CrinetiCARE program, offering $0 copay assistance to eligible patients. Some insurers still require patients to try cheaper generic injectables first before covering PALSONIFY. That payer hurdle, combined with ongoing R&D spending and net losses despite rising revenue, remains a concern for some market watchers, according to Hanna Herald.
Safety Profile Solid, But Traditionalists Flag Limits
The most common side effects reported in more than 5% of patients were diarrhea, abdominal pain, and nausea. These are expected for drugs that target somatostatin receptors. The safety profile has been consistent across the trial program and has not raised new concerns with extended use, Seaforth Huron Expositor noted.
Some specialists argue that for patients with very large or aggressive tumors, injectable pasireotide may still be superior. That drug hits a broader range of receptors than paltusotine's selective focus. There are also questions about whether the pill normalizes raw growth hormone levels as consistently as injectables in certain patients. Still, the 2026 update to the Acromegaly Consensus Recommendations has already begun listing oral therapies as a viable alternative for patients previously controlled on shots, according to Pincher Creek Echo.
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