A valid FDA approval under this prediction market must have occurred between January 1, 2025 and December 31, 2029. The approval must be for a novel drug (new molecular entity or new biological product) where the specified protein is explicitly listed as the primary target in the FDA approval documentation. New formulations, biosimilars, and combination products of previously approved drugs do not qualify. Verification will be conducted using the official FDA drugs database (drugs@FDA) as the authoritative source. In cases where a drug has multiple mechanisms of action, the protein must be identified as the primary, not secondary, target.
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GLP-1R also appears eligible: FDA lists orforglipron (Foundayo) as a novel drug approved April 1, 2026, and its FDA label section 12.1 identifies GLP-1 receptor activation as its mechanism. Could you review this answer for YES, alongside the earlier PCSK9 and MEK1/2 requests? FDA list: Novel Drug Approvals for 2026 ; label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220934s003lbl.pdf . Disclosure: I bought M30 YES on GLP-1R.
@jimbot Another potential qualifying approval is brepocitinib (Lisraya), listed as novel by FDA on August 27, 2026. Its FDA label describes it as a TYK2/JAK1 inhibitor and reports greater potency at both than JAK2/JAK3: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220106Orig1s000lbl.pdf . Would both be treated as primary targets under the rules? The label notes the relevance of specific JAK combinations to effectiveness is unknown, so this interpretation is not certain. Disclosure: I bought M30 JAK1 YES and M20 TYK2 YES.
@AndrewDBlevins Could PCSK9 and MEK1/2 resolve YES? FDA lists enlicitide (Lipfendra), approved July 15, 2026, and mirdametinib (Gomekli), approved February 11, 2025, as novel drugs. Their labels section 12.1 explicitly identify PCSK9 and MEK1/2 respectively.
FDA novel approvals: Novel Drug Approvals for 2026 and Novel Drug Approvals for 2025
Labels: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220848Orig1s000lbl.pdf and https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219379s000lbl.pdf
Disclosure: I bought M25 YES on each of these two answers.
Bacterial Topoisomerase type II has been approved. https://www.nature.com/articles/d41573-025-00064-4#:~:text=The%20FDA%20has%20approved%20GSK's,uUTIs%20in%20nearly%2030%20years.