[zmgsabst]

What’s the process for this to be tested and moved onwards toward approved use?

[epistasis]

Phase 1: basic safety, some amount of dose-finding. Small number of patients.

Phase 2: does it appear to work as intended, tested in a larger number of people

Phase 3: is it better than alternatives.

Then approval, followed by monitoring of the drug and side effects.

There's also an additional phase of getting insurance to pay for the new drug, which can be the most difficult.

https://www.cancer.org/cancer/managing-cancer/making-treatme...

[anotherboffin]

Nice summary! From my limited knowledge in case someone’s more interested. Don’t know if it’s different in oncology.

Phase 1 is pretty big on safety: sentinel dosing, then gradually increasing doses until the established max is reached or until serious side effects show up. Generally also includes PK/PD aspects: what is the half-life, how long it’s detectable in the body, does this match the modeling? How is the drug eliminated? All this is used to refine the dosing (if need be) but also provides a lot of the information needed for the safety documentation.

[piyh]

Phase 1 trial scheduled to end in March 2024

https://classic.clinicaltrials.gov/ct2/show/NCT05227326

[jokowueu]

Tbh Since it's a small molecule you can just hire a lab to make a custom synth , I've seen it done a few times,

[syntaxing]

So…what kind of labs can you hire to make this and how much would it cost?

[jokowueu]

It depends on the difficulty of making it and the amount required.

https://pastebin.com/0pyuDBX1

[anotherboffin]

Formulation is pretty important too. Do they give any detail on that?