ENDO-205 is all over your feed. Jo Barry, owner of Scarlet, on what the FDA actually cleared, and what it costs a person to read a headline that carefully.
The correction was already in the comments when I got there.
One woman had posted the lot. FDA clearance in March, an Investigational New Drug application, Phase 1 only, source cited, and the plain fact that the thing has to clear three phases before anyone gets near it. Another had done the timeline underneath. Five to ten years, might never be commercialised, and selling fake hope to people who are already suffering isn't kind.
I keep seeing this sort of thing shared as if it's heartwarming. Look at the community, pulling together, doing their research. It isn't heartwarming.
You don't end up with a comment section full of unpaid regulatory analysts because everyone in it happens to enjoy reading FDA filings. You end up with one because these women have been burned so many times that they've had to learn to do it themselves. Nobody chooses that. It gets installed in you.
What the FDA actually did
Cleared an Investigational New Drug application for a company called EndoCyclic Therapeutics. That's the form you fill in before you're allowed to give a drug to a human being.
Nobody has actually taken it. No trial dates, no locations, nowhere in the world.
When it does start, Phase 1 runs in healthy women rather than women with endo, and it asks one question: Is it safe enough to keep going.
Somewhere between that and Facebook, it became an FDA-cleared treatment that destroys lesions and preserves your fertility. The fertility line appears nowhere in the company's announcement. Someone typed it in themselves, and thousands of people who have spent years being told to wait read it and believed it.
The question nobody has answered
Here's the sentence the whole story rests on, from EndoCyclic's own release. In preclinical studies, ENDO-205 demonstrated elimination of endometriosis lesions and associated inflammation.
That's the entire disclosure. No model, no measurement. The method isn't published anywhere I can find.
A woman in the comments went straight at it. If scans can barely find endo in a living person, how did anyone establish the lesions were gone? Did they operate before and after to check? Surface lesions only, or the deep ones as well?
She apologised for asking. It's the sharpest question anyone has put to this drug.
There's nothing sinister in the silence, for what it's worth. Companies sit on preclinical details constantly. It just means the claim is currently out in front of the evidence any of us are allowed to see, and she was the one who noticed.
What it costs to read like that
I had my first laparoscopy in 1999. I've been reading endometriosis breakthrough headlines ever since.
Seven laparoscopies. Two bowel resections. Then a radical hysterectomy, because by then there was nothing gentler left to try. I own a period brand and I own zero periods. My body quit without notice, so I built a company out of spite.
Somewhere in those years, I stopped being able to read a headline like a normal person. Every announcement gets held at arm's length and turned over before I'll let myself want it. That reflex has saved me a lot of disappointment.
Diagnosis in this country still takes 6.5 to 8 years. Most of us spent that time being told our pain was normal. You come out the other side of that unable to take anyone's word for anything, and then people call it resilience.
For what it's worth
The drug itself looks like the right direction. Non-hormonal, which, if you've done Zoladex, needs no further explanation. Aimed at the lesions instead of your whole endocrine system, which is roughly where this should have gone thirty years ago. Real money behind it too, NIH funding and a perfect-score grant, which nobody hands out for a press release.
It might work. I hope it does, and I'll be reading the Phase 1 results with everyone else.
What I'd rather have back is the twenty-six years it took to teach a few hundred thousand women to check the source before they let themselves hope. Jo xx