This section highlights FDA-related milestones and regulatory updates for drugs developed by MBX Biosciences (MBX).
Over the past two years, MBX Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
canvuparatide, MBX, MBX, and MBX. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Canvuparatide FDA Regulatory Events
Canvuparatide is a drug developed by MBX Biosciences for the following indication: for Hypoparathyroidism.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- canvuparatide
- Announced Date:
- September 22, 2025
- Indication:
- for Hypoparathyroidism
Announcement
MBX Biosciences, Inc. announced once-weekly canvuparatide achieved the primary endpoint with statistical significance at Week 12 in its Phase 2 Avail™ trial, and demonstrated positive 6-month results from the OLE, in adult patients with chronic hypoparathyroidism (HP). All patients (n=64) completed the 12-week study, and 94% of patients elected to enroll in the OLE.
AI Summary
MBX Biosciences, Inc. announced that once-weekly canvuparatide achieved the primary endpoint with statistical significance at Week 12 in its Phase 2 Avail™ trial in adult patients with chronic hypoparathyroidism. In the 12-week study, 63% of treated patients maintained normal serum calcium levels without rescue therapy, compared with 31% of placebo patients. During the six-month open-label extension (OLE), 79% of patients achieved responder status—defined by normal calcium and independence from active vitamin D and high-dose calcium supplements. Key bone and kidney biomarkers also showed positive changes, including increased bone turnover markers and a 48% reduction in urine calcium for those with elevated levels at baseline.
All 64 participants completed the 12-week trial, and 94% elected to join the OLE. Once-weekly canvuparatide was generally well tolerated, with no treatment-related serious adverse events or discontinuations. Mild to moderate injection site reactions occurred in 19% of treated patients. Based on these results, MBX Biosciences is preparing to initiate a Phase 3 trial in 2026. The company will host a conference call today at 8:00 am ET to discuss the data.
Read Announcement- Drug:
- canvuparatide
- Announced Date:
- September 19, 2025
- Estimated Event Date Range:
- September 22, 2025 - September 22, 2025
- Target Action Date:
- September 22, 2025
- Indication:
- for Hypoparathyroidism
Announcement
MBX Biosciences, Inc. announced that it will provide topline results from its Phase 2 clinical trial of potential once-weekly canvuparatide for patients with chronic hypoparathyroidism (HP) and host an investor webcast on Monday, September 22.
AI Summary
MBX Biosciences, Inc. announced it will provide topline results from its Phase 2 clinical trial of once-weekly canvuparatide in patients with chronic hypoparathyroidism (HP). The Avail™ study is designed to assess safety, hormone levels and effectiveness in people who need more stable calcium control. The company hopes the data will show that a weekly injection could offer an improved treatment option.
An investor webcast and conference call will be held at 8 a.m. ET on Monday, September 22 to discuss the Avail™ trial results. Interested parties can join the live webcast on the MBX website or dial 1-877-407-0779 (US) or 1-201-389-0914 (international). A replay and slide deck will be available in the Investors section of the site after the event.
MBX Biosciences is a clinical-stage biopharmaceutical company developing precision peptide therapies for endocrine and metabolic disorders. To learn more, visit mbxbio.com.
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MBX 4291 FDA Regulatory Events
MBX 4291 is a drug developed by MBX Biosciences for the following indication: For the Treatment of Obesity.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MBX 4291
- Announced Date:
- September 4, 2025
- Indication:
- For the Treatment of Obesity
Announcement
MBX Biosciences, Inc. announced dosing of the first participant in its Phase 1 trial of MBX 4291, the Company's Precision Endocrine Peptide™ (PEP™) glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) co-agonist prodrug candidate for the treatment of obesity.
AI Summary
MBX Biosciences, Inc. announced dosing of the first participant in its Phase 1 trial of MBX 4291, a PEP™ prodrug co-activating GLP-1 and GIP receptors for obesity treatment. The study is randomized, double-blind, placebo-controlled to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in adults with obesity.
The trial has two parts. Part A tests single ascending doses in five cohorts of eight participants each, randomized 3:1 to MBX 4291 or placebo, with a 63-day follow-up. Part B evaluates multiple ascending doses over four weeks in three similar cohorts, followed for 71 days.
MBX 4291 is built on the company’s PEP™ platform and showed strong preclinical weight-loss results similar to tirzepatide, with extended action supporting once-monthly dosing. MBX Biosciences expects topline results in 2027 and aims to deliver improved gastrointestinal tolerability, enhanced adherence, and greater long-term weight loss compared to existing treatments.
Read Announcement- Drug:
- MBX 4291
- Announced Date:
- June 16, 2025
- Indication:
- For the Treatment of Obesity
Announcement
MBX Biosciences, Inc. announced submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MBX 4291, a long-acting glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug for the treatment of obesity.
AI Summary
MBX Biosciences announced the submission of an Investigational New Drug (IND) application to the U.S. FDA for its new candidate, MBX 4291, a long-acting GLP-1/GIP receptor co-agonist prodrug targeting obesity. The drug is developed using MBX’s proprietary PEP™ platform and is designed for once-monthly administration. This innovative approach aims to deliver improved gastrointestinal tolerability, which could help patients maintain adherence while achieving significant weight loss. In preclinical studies, MBX 4291 demonstrated similar activity to current obesity treatments but with an extended duration of action that supports less frequent dosing. Following IND clearance, MBX Biosciences plans to initiate a Phase 1 clinical trial in healthy overweight volunteers in the third quarter of 2025. This IND submission represents a key milestone in the company’s efforts to develop next-generation precision peptide therapies for metabolic disorders.
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MBX 1416 FDA Regulatory Timeline and Events
MBX 1416 is a drug developed by MBX Biosciences for the following indication: For the Treatment of Post-Bariatric Hypoglycemia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MBX 1416
- Announced Date:
- March 17, 2025
- Indication:
- For the Treatment of Post-Bariatric Hypoglycemia
Announcement
MBX Biosciences, Inc. highlighted recent corporate progress.
AI Summary
MBX Biosciences, Inc. showcased significant corporate progress as it heads into 2025 with strong momentum from 2024. The company completed patient enrollment in the Phase 2 Avail™ trial of canvuparatide for hypoparathyroidism, with topline results expected in the third quarter of 2025. This major milestone supports MBX’s commitment to developing novel therapies that address endocrine and metabolic disorders. In addition to the canvuparatide advancement, MBX is preparing to start a Phase 2 trial for MBX 1416 in patients with post-bariatric hypoglycemia later in 2025, reflecting continued progress in its research and development efforts.
Financially, the company reported a robust cash position of $262.1 million as of December 31, 2024, which is expected to fund operations through mid-2027. These recent strides, along with new leadership appointments, highlight MBX Biosciences’ continued drive toward innovative precision peptide therapies.
Read Announcement- Drug:
- MBX 1416
- Announced Date:
- January 7, 2025
- Indication:
- For the Treatment of Post-Bariatric Hypoglycemia
Announcement
MBX Biosciences, Inc. announced positive results from its Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of MBX 1416 in healthy adult volunteers.
AI Summary
MBX Biosciences, Inc. announced that its Phase 1 clinical trial of MBX 1416 in healthy adult volunteers yielded positive results. In both the single ascending dose (SAD) and multiple ascending dose (MAD) arms, MBX 1416 was generally well-tolerated and displayed a favorable safety profile. The pharmacokinetic data showed sustained, dose-dependent exposure, supporting once-weekly dosing. An interesting finding was an observed increase in GLP-1 levels during the first hour after a mixed meal tolerance test, which could signal therapeutic benefits for patients suffering from post-bariatric hypoglycemia (PBH).
Based on these promising Phase 1 results, the company plans to initiate a Phase 2 study in PBH patients in the second half of 2025, pending alignment with the FDA. MBX Biosciences further discussed trial findings during a conference call, underscoring the potential of MBX 1416 as an innovative treatment option for PBH.
Read Announcement- Drug:
- MBX 1416
- Announced Date:
- November 18, 2024
- Indication:
- For the Treatment of Post-Bariatric Hypoglycemia
Announcement
MBX Biosciences, Inc. announced the completion of the last subject's last visit in its Phase 1 single and multiple ascending dose trial of MBX 1416, the Company's long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist in development for the treatment of post-bariatric hypoglycemia (PBH).
AI Summary
MBX Biosciences, Inc. announced that the final visit of the last subject in its Phase 1 clinical trial of MBX 1416 has been completed. This trial is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of MBX 1416, a long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist designed to treat post-bariatric hypoglycemia (PBH). PBH is a serious complication that can occur after bariatric surgery, causing severe low blood sugar episodes with potentially dangerous symptoms. The study was conducted in healthy adult participants using a randomized, double-blind, placebo-controlled design. With a total of 69 subjects, the trial’s primary goal was to assess the compound’s safety and tolerability, along with its overall behavior in the body. MBX Biosciences plans to share the full topline results in early January 2025.
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MBX 2109 FDA Regulatory Timeline and Events
MBX 2109 is a drug developed by MBX Biosciences for the following indication: In adults with hypoparathyroidism.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MBX 2109
- Announced Date:
- March 3, 2025
- Indication:
- In adults with hypoparathyroidism
Announcement
MBX Biosciences, Inc announced the completion of enrollment in its Phase 2 Avail™ trial of MBX 2109 (canvuparatide), the Company's parathyroid hormone (PTH) peptide prodrug.
AI Summary
MBX Biosciences, Inc. has reached a key milestone by completing enrollment in its Phase 2 Avail™ trial of MBX 2109 (canvuparatide), a parathyroid hormone (PTH) peptide prodrug. Canvuparatide is being developed as a long-acting treatment for chronic hypoparathyroidism (HP), aiming to better manage the condition by providing consistent therapeutic effects and reducing calcium fluctuations. The study, which is randomized, multicenter, and double-blind, enrolled 64 patients over a 12-week period. The main goal is to determine if patients can reduce vitamin D and calcium supplements while keeping their calcium levels in a normal range. MBX Biosciences expects to share the trial's top-line results in the third quarter of 2025, potentially marking a breakthrough in improving patient convenience and overall treatment effectiveness for those suffering from HP.
Read Announcement- Drug:
- MBX 2109
- Announced Date:
- December 2, 2024
- Indication:
- In adults with hypoparathyroidism
Announcement
MBX Biosciences, Inc. announced the publication of a peer-reviewed article highlighting results from the Phase 1 study of MBX 2109, the Company's parathyroid hormone (PTH) peptide prodrug in development for the treatment of hypoparathyroidism (HP).
AI Summary
MBX Biosciences, Inc. announced the publication of a peer-reviewed article in The Journal of Clinical Endocrinology and Metabolism detailing Phase 1 study results of MBX 2109, a parathyroid hormone peptide prodrug being developed for hypoparathyroidism treatment. The study, which enrolled 40 healthy adults in a randomized, double-blind trial, investigated the safety, pharmacokinetics, and pharmacodynamics of once-weekly subcutaneous doses of MBX 2109. Results showed that the prodrug has a long half-life—with peak-to-trough exposure levels remaining relatively flat—suggesting a steady therapeutic effect that may reduce symptoms associated with calcium fluctuations. The findings, indicating a favorable safety profile with only mild adverse events reported, support the further development of MBX 2109. The company plans to proceed with a Phase 2 trial in patients with hypoparathyroidism in early 2025.
Read Announcement- Drug:
- MBX 2109
- Announced Date:
- September 30, 2024
- Indication:
- In adults with hypoparathyroidism
Announcement
MBX Biosciences, Inc. announced that both the rationale and design of the Phase 2 Avail™ trial of MBX 2109, the Company's potential long-acting parathyroid hormone (PTH) peptide prodrug, in adults with hypoparathyroidism (HP) were featured in a poster presentation at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting held in Toronto, ON, Canada September 27-30, 2024.
AI Summary
MBX Biosciences recently revealed key details about its Phase 2 Avail™ trial for MBX 2109, a long-acting parathyroid hormone (PTH) peptide prodrug designed to treat adults with hypoparathyroidism. The study’s rationale and design were showcased in a poster presentation at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting in Toronto, Canada, held from September 27-30, 2024. The trial evaluates whether MBX 2109 can help maintain normal calcium levels while reducing dependency on active vitamin D and calcium supplements. Patients in the study are receiving weekly doses, offering the potential for a more convenient treatment option that targets the underlying cause of the disease. With dosing that began in August 2024, the company anticipates topline results in the third quarter of 2025, marking a significant step toward improving the quality of life for those affected by hypoparathyroidism.
Read Announcement
