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GUBamy (GUB014295)

Early human Weight Loss & Metabolism 3 sources

GUBamy (GUB014295) is a novel, long-acting dual amylin and calcitonin receptor agonist (DACRA) developed by Gubra and licensed to AbbVie. It represents a mechanistically distinct approach to obesity treatment compared to GLP-1 receptor agonists, showing significant weight loss potential and an 11-day half-life that supports once-weekly dosing.

01Dosing reference

Amount
0.5 mg - 2 mg (based on Phase 1 trials)
Frequency
Once weekly
Cycle
Ongoing clinical evaluation (e.g., 6-week evaluation in Phase 1)
Reference figures, not a recommendationThese values reflect amounts described in the literature and vendor documentation this database indexes. Use the reconstitution calculator to convert them into syringe units.

02Mechanism of action

01

Dual Receptor Activation

GUBamy binds to and activates both amylin receptors (AMY1-3) and calcitonin receptors (CTR) in the brainstem, specifically the area postrema.

02

Appetite and Gastric Regulation

This activation suppresses appetite, delays gastric emptying, and reduces postprandial glucagon secretion, independent of the GLP-1 pathway.

03

Weight Loss and Metabolic Control

The combined effects lead to sustained reductions in food intake and significant body weight loss, with potential for additive effects when combined with GLP-1 therapies.

03Human evidence

In a Phase 1 Multiple Ascending Dose (MAD) interim analysis, GUBamy at 2 mg weekly produced a 7.77% mean weight loss by day 43.

Phase 1 MAD interim data in healthy/overweight volunteers; compared to 1.99% weight gain with placebo. Early stage data requiring confirmation in larger trials.

GUBamy demonstrated a favorable pharmacokinetic profile with an 11-day half-life, supporting once-weekly subcutaneous administration.

Phase 1 Single Ascending Dose (SAD) trial in healthy subjects. The drug was well tolerated with predominantly mild, transient gastrointestinal adverse events.

04Preclinical evidence

GUBamy showed dose-dependent and sustained reduction in food intake lasting over 140 hours after a single dose.

Diet-Induced Obese (DIO) rat model evaluating single-dose administration.

Co-administration of GUBamy with GLP-1, GLP-1/GIP, or GLP-1/glucagon agonists resulted in additive body-weight and fat mass loss.

4-week combination study in DIO rats, demonstrating synergistic potential with existing incretin therapies.

05What is known vs. unknown

Reasonably established
  • GUBamy is a dual amylin and calcitonin receptor agonist (DACRA), offering a non-GLP-1 mechanism for weight management.
  • It has an extended half-life of approximately 11 days (270 hours), allowing for convenient once-weekly dosing.
  • Phase 1 clinical data indicates significant early weight loss (7.77% at 43 days with 2 mg weekly).
  • Preclinical data strongly supports its use in combination with GLP-1 receptor agonists for enhanced efficacy.
Unknowns & limits
  • Long-term safety, efficacy, and tolerability in large, diverse patient populations remain unknown as it is only in early clinical development.
  • The clinical efficacy and safety of combining GUBamy with GLP-1 therapies have not yet been established in human trials.
  • The prolonged 11-day half-life means that if severe adverse events occur, the drug will remain in the system for an extended period.

06Safety & regulatory context

Regulatory statusGUBamy is an investigational drug currently in early clinical development (Phase 1/2) and is not approved by the FDA or any regulatory body for use outside of clinical trials. In Phase 1 studies, it was generally well tolerated, with the most common adverse events being gastrointestinal in nature (e.g., nausea), which were typically mild and transient. Its long half-life (11 days) is beneficial for weekly dosing but requires careful monitoring during dose escalation, as adverse effects may persist. In March 2025, AbbVie licensed GUBamy from Gubra for global development in obesity.

07Compared with Pramlintide (Symlin)

GUBamy (GUB014295) vs. Pramlintide (Symlin)
Key difference
Pramlintide is a short-acting amylin analog requiring multiple daily injections, whereas GUBamy is a long-acting dual amylin/calcitonin agonist designed for once-weekly administration.
When researchers discuss each
Pramlintide is discussed as an FDA-approved adjunct therapy for diabetes mealtime glucose control, while GUBamy is discussed as a next-generation, long-acting investigational agent primarily targeted for obesity and weight management.

08Glossary

DACRA
Dual Amylin and Calcitonin Receptor Agonist; a molecule that activates both of these receptor types to regulate metabolism and appetite.
Area Postrema
A structure in the brainstem that controls vomiting and plays a key role in regulating food intake and appetite, which is a primary target for amylin analogs.
Amylin
A peptide hormone co-secreted with insulin from the pancreas that helps regulate glucose and promotes satiety.

09Knowledge check

Q1What is the primary mechanism of action of GUBamy?
Q2What pharmacokinetic property of GUBamy allows for its once-weekly dosing schedule?
Q3Which interpretation best matches the limitations of the current clinical evidence for GUBamy as described in the dossier?
Q4When comparing GUBamy and pramlintide using the dossier's stated context, which statement is most accurate?
Q5Which safety or regulatory statement about GUBamy is supported by the dossier?

10Sources

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Research and educational use onlyNothing on this site is medical advice, a prescription, or a recommendation for human use. Compounds documented here are research chemicals. Consult a qualified clinician before making any health decision.