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

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@njx58 indeed!

For this study - Combined Anabolic Therapy (CAT):

Inclusion Criteria:

women aged 45+
postmenopausal
osteoporotic with high risk of fracture

Exclusion Criteria:

no significant previous use of bone health modifying treatments
known congenital or acquired bone disease other than osteoporosis
significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
abnormal calcium or parathyroid hormone level
serum vitamin D <20 ng/dL
anemia (hematocrit <32%)
history of malignancy (except non-melanoma skin carcinoma)
excessive alcohol use or substance abuse
known contraindications to romosozumab or teriparatide

information provided by Dr. Benjamin Leder and is available on ClinicalTrials.gov ID NCT06558188

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Replies to "@njx58 indeed! For this study - Combined Anabolic Therapy (CAT): Inclusion Criteria: women aged 45+ postmenopausal..."

@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