Will AOH1996 be FDA approved before 2040?

Ṁ3.5kṀ10k

2040

40%

chance

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This market concerns AOH1996, a cancer therapeutic reported in this paper. See also this Wikipedia page. As of 2023-08-02, AOH1996 is in Phase I clinical trials for the treatment of solid tumors.

This market resolves YES if AOH1996 gets FDA approval for use in humans at any time before 2040. This includes fast track, breakthrough therapy, accelerated approval, and priority review, as well as the normal approval pathway. It also includes any new approval pathways the FDA may develop prior to 2040. AOH1996 may be approved as a mono- or combination therapy.

I will not bet in this market.

At the time of writing, I am aware only of this other AOH1996 market. I created this market to additionally capture the long tail of less glamorous outcomes, including slow approval, approval for only small disease area, and approval as a combination therapy.

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Base rates and status. AOH1996 is still in Phase 1 four years in: the solid-tumour study (NCT05227326, started August 2022, 92 planned participants) lists primary completion in September 2029, a second Phase 1 in relapsed or refractory AML (NCT06763341) started in July 2025, and no Phase 2 is registered. Historically about 5% of oncology drugs entering Phase 1 reach approval (BIO/Informa analysis of 2011 to 2020 transitions), with a median of roughly a decade from first-in-human to approval, so 2040 is reachable on time but the market's 40% is about eight times the base rate, resting on a 2023 preprint-era claim of 70 cell lines and mouse xenografts plus six patients without drug-related toxicity (April 2024). The usual bridge between mouse and human efficacy for an oral cancer drug is dogs with spontaneous tumours (the NCI runs a Comparative Oncology Trials Consortium for this), and no such study of AOH1996 has been published. Same reason aging drugs are tested for lifespan in dogs first; registry (mine): https://w0lph.github.io/k9/trials/

Canine aging trial registry

Registry of 37 interventional studies and cohorts on aging in dogs, each typed and backed by verbatim source quotes.

Some doubts here: https://www.sciencemediacentre.org/expert-reaction-to-study-on-use-of-small-molecule-ligand-aoh1996-for-inhibiting-tumour-growth-in-animals

This may be too high. Based on here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6226120/#:~:text=The%20observed%20success%20rates%20of,(NDA%2FBLA)%20phase

The cumulative probability seems closer to 18%-22%.

the deadline of 2040 creates an additional pressure for this to resolve as no.

Edit: probably not. Doesn’t seem like 15+ years is much of a restriction.

I'm excited about this compound but this seems crazy high given the phase I to approval prior (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6409418/).