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Oral teriparatide tablet (EB613) gets FDA nod for Phase 3 trial
Osteoporosis & Bone Health | Last Active: Jun 30 2:13pm | Replies (28)Comment receiving replies
@mayblin Such good news about the possibility of an oral anabolic! I think the previous trial locations were all in Israel. Anyone on this forum located in Israel may want to watch out for the Phase 3 study.
The latest trial is listed as a Phase 1 study, so it is curious to me that they will jump to Phase 3 next.
Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo https://clinicaltrials.gov/study/NCT05965167
Entera earlier appear to have done a Phase 2 trial on the EBP05 formulation that they then compared in the later trial that finished in early 2026.
A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass https://clinicaltrials.gov/study/NCT04003467
NOTE: The drug company has been working on oral PTH(1-34) formulations since before the Phase 2 study start date listed as 2019. And the drug still may fail for taking in oral form. It seems good sport to tilt at "big pharma" but bringing a new drug to market is very expensive and there is nobody else who will pay for a big study like the one planned. It seems as if the next study is also going to leverage the new osteoporosis treat-to-target FDA rules that allow BMD, instead of fracture reduction, to determine success. If the drug is successful then that will save many years of lead time in bringing it to market, although with the trade-off of more risks.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-qualifies-total-hip-bone-mineral-density-bmd-surrogate-endpoint-osteoporosis-drug-development
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@kfhoz thank you very much for the detailed info and thoughtful comments!
A few clarifications,
EBP05 and EB613 are the same drug. The Phase 2 trial (NCT04003467) was registered on ClinicalTrials.gov under the name "EBP05," but the published results of that same trial - same number of patients, same doses, same investigators - refer to the drug as "EB613." EBP05 was simply the earlier development name.
The Phase 1 study after Phase 2 isn't a step backward in this scenario. For a truly new drug (brand new chemical entity NCE), the standard path is Phase 1 → 2 → 3, where Phase 1 is the first-in-human study to establish basic safety and how the drug behaves in the body (pharmacology study). But 'Phase 1' also describes another kind of study - a bridging study. When a company modifies its tablet (changes in coating, absorption enhancers, excipients, or manufacturing process, etc.), regulators require a study to confirm the reformulated tablet delivers the drug into the bloodstream comparably to the original. This pharmacokinetic (PK) study is classified as Phase 1, but this doesn't mean the program is starting over. So the sequence here is logical: Phase 2 (original formulation, completed) → Phase 1 bridging study (new vs. old formulation, completed early 2026) → Phase 3 (trial with the optimized formulation).
What's particularly interesting from the Phase 2 data is that oral PTH(1-34), or EBP05/EB613, appeared to have a different BTM kinetic profile from the injected version - it simultaneously stimulated bone formation markers and suppressed bone resorption markers, whereas injected teriparatide increases both. If confirmed in Phase 3, this dual mechanism could be a meaningful clinical differentiator, in addition to the convenience advantage over injections.
Your point about the hip BMD surrogate endpoint is spot on, and thanks for the link. The FDA now accepts total hip BMD improvement as evidence the drug works, rather than requiring years of data showing fewer fractures. This could significantly shorten the path to approval, with the tradeoff being less long-term fracture data at the time of approval.
The Phase 3 trial is expected to be larger (~750 participants) and likely multinational, potentially including US sites - worth watching for anyone interested in participating.