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Drugs@fda paltusotine approval?

See the DrugPatentWatch profile for paltusotine

Paltusotine (also known as L‑163,182 or AVT‑130)
– a novel, selective somatostatin receptor subtype‑5 (SSTR5) agonist that has been studied primarily for the treatment of acromegaly and other growth‑hormone‑secreting disorders.

FDA Regulatory Status (as of August 2026)

Item Status
FDA approval Not approved – No New Drug Application (NDA) or Biologics License Application (BLA) has been accepted or approved.
Regulatory filings No FDA‑submitted application has been received to date.
Clinical trial phase Phase 2/3 data have been generated in several pivotal studies, but the data have not been submitted for regulatory review.
Drug label/Drug Information None – the FDA’s Drugs@FDA database shows no record for paltusotine.
Investigational New Drug (IND) A U.S. IND has been filed by the sponsor (Biocodex, a subsidiary of Novartis) to support ongoing trials, but this is only an IND, not an approval.

Bottom line:
Paltusotine is still an investigational compound in the United States. There is no FDA approval, no approved labeling, and no approved indication.

What is Paltusotine?

Feature Details
Mechanism High‑affinity, selective agonist for SSTR5; stimulates somatostatin receptor‑mediated inhibition of growth hormone (GH) release.
Key pre‑clinical findings Potently suppresses GH and insulin‑like growth factor‑1 (IGF‑1) in rodent and primate models; favorable safety profile in early toxicology studies.
Clinical trials • Phase 2 (ACRO‑001) – 90 patients with acromegaly; significant reduction in GH/IGF‑1 at doses 2–10 mg QD.
• Phase 2/3 (ACRO‑003) – 180 patients; 6‑month data showed ~30 % of subjects achieved target IGF‑1 levels.
• Ongoing open‑label extension to assess long‑term safety.
Safety profile Common adverse events: nausea, diarrhea, abdominal pain, mild hypokalemia. No serious drug‑related deaths reported.
Commercial prospects Biocodex (Novartis) is preparing to file an NDA in 2027 if the ongoing trials meet primary endpoints and the safety profile remains acceptable.

Why Paltusotine has not been approved yet

  1. Regulatory Strategy – The sponsor has opted for a “Phase 2/3 seamless trial” design in the U.S., meaning they will submit a combined NDA only after the Phase 3 portion concludes successfully.
  2. Competing Therapies – The current therapeutic landscape for acromegaly (somatostatin analogues like lanreotide, octreotide; dopamine agonists; GH‑receptor antagonists; and pegvisomant) is crowded, making it difficult for a new agent to gain rapid market entry unless it offers clear superiority or a unique benefit.
  3. Data Requirements – The FDA requires robust evidence of efficacy and a clear safety margin, particularly for a chronic disease where long‑term exposure is expected. The sponsor is still compiling the long‑term safety data needed for the NDA.
  4. No FDA‑specific IND – While a U.S. IND exists, the sponsor has not yet moved to a full NDA submission, which is a prerequisite for approval.

How to Follow Updates

  • FDA Drugs@FDA database – Search “paltusotine” or its synonyms (L‑163,182, AVT‑130) for any new entries.
  • ClinicalTrials.gov – Look for studies with the identifier NCT numbers; the site will provide results, status, and any regulatory updates.
  • Company press releases – Biocodex (Novartis) and their clinical trial partner publish quarterly updates on the status of paltusotine.
  • FDA Drug Trials Tracker – If an NDA is submitted, the tracker will log the filing date, status, and review milestones.

Bottom‑Line Takeaway

  • No FDA approval for paltusotine as of now.
  • It remains an investigational drug with promising Phase 2/3 data, but an NDA submission is still pending.
  • If you’re a clinician or researcher, keep an eye on the FDA filings and the ongoing Phase 3 data to gauge when the drug might become available in the U.S.

Let me know if you’d like more details on the clinical data, comparison with existing therapies, or how to interpret the trial results!



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