A new oral tablet called EB613 is poised to become the first pill that builds bone density in postmenopausal women with osteoporosis, potentially transforming how millions receive treatment that was previously only available as injections. The medication, developed by Entera Bio, has cleared a major FDA milestone and is expected to enter large-scale clinical trials in late 2026, with results potentially available by the second half of 2028 .

Currently, bone-building medications for osteoporosis exist, but they come with a significant barrier: they're only available as injections. This limits access dramatically. Most patients with osteoporosis never receive these powerful bone-strengthening treatments because injections require frequent doctor visits, can be inconvenient, and aren't accessible to everyone. EB613 aims to change that by offering the same bone-building power in a simple tablet form .

"2025 was a landmark year for Entera, our EB613 program and for the osteoporosis community as a whole. While current injectable anabolic or bone forming agents are accepted or accessed by a minority of osteoporosis patients in whom they should be used, our mission with EB613 is to democratize anabolic treatment. EB613 is being developed as the first oral bone building tablet so potentially, every woman and man can have the opportunity to protect their bones whether they are being treated with a primary care practitioner or a specialist," said Miranda Toledano, Chief Executive Officer of Entera.

Miranda Toledano, Chief Executive Officer at Entera Bio Ltd.

What Makes EB613 Different From Current Osteoporosis Treatments?

EB613 contains PTH(1-34), the same active ingredient found in injectable bone-building medications like Forteo. However, the tablet formulation is genuinely novel. In early testing, researchers found that a single tablet delivered comparable bone-building effects to the multi-tablet version and matched the performance of the injectable Forteo in terms of how the body absorbs and processes the medication .

The clinical evidence is compelling. In Phase 2 trials, EB613 showed significant increases in both trabecular bone (the spongy interior of bones) and cortical bone (the dense outer layer) after just six months of treatment. These improvements were comparable to what researchers see with injectable teriparatide and abaloparatide, two established bone-building medications . This rapid onset matters because stronger bones mean lower fracture risk.

The medication also showed consistent benefits across different groups of women. Post-hoc analysis from Phase 2 trials demonstrated that EB613 drove significant bone mineral density (BMD) gains at the spine, femoral neck, and hip in both younger women within 10 years of menopause and those more than 10 years past their last menstrual period . For younger high-risk women without a prior fracture, bone density is the single most important predictor of future osteoporotic fractures.

How Did EB613 Get FDA Approval to Move Forward?

In July 2025, the FDA took an unusual step: it formally agreed with Entera's proposed study design for Phase 3 trials, making EB613 the first company to receive such independent alignment on this approach . The FDA also issued a broad qualification stating that percentage change in total hip bone mineral density at 24 months could serve as a validated surrogate efficacy endpoint for novel osteoporosis drug development .

This FDA alignment streamlined the path forward significantly. Instead of requiring a 24-month Phase 3 trial with 750 postmenopausal women, Entera submitted a revised protocol in March 2026 that measures the primary outcome at 12 months rather than 24 months. This change substantially reduces enrollment requirements and accelerates the timeline to potential approval, with topline results now expected approximately one year earlier than previously anticipated .

Steps to Understanding Your Osteoporosis Treatment Options

• Know Your Bone Density Status: Ask your doctor about bone density screening, especially if you're postmenopausal or have risk factors for osteoporosis. Bone mineral density testing is the standard way to diagnose osteoporosis and track treatment effectiveness.
• Understand Current Treatment Types: Osteoporosis medications fall into two main categories: those that slow bone loss (like bisphosphonates) and those that actively build bone (anabolic agents like PTH-based medications). Your doctor can help determine which approach is right for your situation.
• Ask About Treatment Access: If your doctor recommends a bone-building medication, discuss whether you prefer injectable or oral options. As new oral formulations become available, you'll have more choices that fit your lifestyle and preferences.
• Monitor Treatment Response: Follow-up bone density scans help confirm that your treatment is working. Significant improvements in bone density typically appear within 6 to 12 months of starting bone-building therapy.

When Will EB613 Be Available to Patients?

The timeline is ambitious but realistic. Entera expects FDA feedback on its Phase 3 protocol in late April 2026, with the large-scale trial launching in late 2026 . If enrollment proceeds smoothly and the medication shows the expected bone-building benefits, topline results could arrive by the second half of 2028. From there, the FDA would review the complete application, a process that typically takes several months to over a year .

This means patients could potentially have access to EB613 sometime in 2029 or 2030, assuming the Phase 3 trial meets its primary endpoints. For people currently struggling with injectable bone-building medications or those who've avoided them due to inconvenience, this represents a meaningful shift in osteoporosis care.

The broader significance extends beyond convenience. By making bone-building treatment available as a simple tablet, EB613 could reach millions of postmenopausal women who currently don't receive these powerful medications. Primary care doctors could prescribe it without requiring patients to visit specialists or infusion centers. This democratization of anabolic bone therapy could substantially reduce fracture rates and improve quality of life for people with osteoporosis across all socioeconomic backgrounds .

While EB613 is still in development, its progress represents genuine innovation in bone health. For anyone concerned about osteoporosis or currently managing the condition, staying informed about emerging treatment options empowers you to have more productive conversations with your healthcare provider about which approach best fits your needs and lifestyle.