Oral teriparatide tablet (EB613) gets FDA nod for Phase 3 trial

Here is the link for press release;
https://www.biospace.com/press-releases/entera-bio-receives-positive-fda-feedback-on-12-month-registrational-phase-3-study-for-eb613-the-first-oral-anabolic-tablet-in-development-for-postmenopausal-women-with-osteoporosis

The trial results are pretty mediocre if you ask me. 2.6% gain in spine after six months? That's not much. I don't see this as a substitute for Evenity, Tymlos, or Forteo unless someone absolutely can't tolerate those medications.

The phase 2 results for oral teriparatide (EB613) are not mediocre - they are actually quite competitive at the 6mo mark, particularly at the hip and femoral neck, which are the sites where fractures matter most. Lumbar spine BMD gains do appear numerically lower than subcutaneous teriparatide at end of 6mo, if that’s what you meant.

What makes this oral form especially interesting is that it works differently from the injection. It builds new bone while simultaneously slowing bone loss - a dual action that the injected form does not achieve. This unique mechanism may turn out to be a real clinical advantage.
https://academic.oup.com/jbmr/article/39/6/672/7641499

@mayblin Very exciting development!
I read: Phase 3 initiation is planned for late 2026 with topline data anticipated in the second half of 2028.
Do you know how to interpret that statement in terms of when this might be available to the general public?

@tillymack i feel the same way.

Phase 3 trials typically run 1-4 years. Based on the press release, the trial is set to begin later this year (2026), with results expected in the second half of 2028. After that comes the formal FDA approval process. So realistically, if everything goes well, we might be looking at roughly 3-5 years before this could become available to the public.

Have you checked to see if we might be eligible to join the clinical trial 🙂

This is great news! I’m not sure but I think you need to be in good health and not have taken any previous drug therapy in order to participate.

That makes sense.

@tillymack
I don't believe recruitment has started yet. You could periodically check ClinicalTrials.gov later this year once they post the inclusion/exclusion criteria. For now, their Phase 2 criteria give a general idea,mthough Phase2 was conducted only in Israel since this is an Israel based company. Phase 3 is larger and will likely be multinational.

Unrelated, but if you or anyone is interested in anabolic therapy sooner, MGH (Mass General) in Boston is actively recruiting for a Phase 4 trial combining teriparatide (Forteo) and romosozumab (Evenity).

@mayblin Hmm... interesting.