ABBV-295
AbbVie's long-acting amylin analog, licensed from Denmark's Gubra in 2025 for $350 million upfront. Its half-life of about 11 days let Phase 1 test weekly, every-other-week and monthly injections: weight fell 7.8–9.8% at 12 weeks on weekly dosing and 7.9% at 13 weeks on monthly dosing, vs about 0.3% on placebo. A 360-person Phase 2 began in August 2026.
ABBV-295 is an experimental weight-loss shot from AbbVie that copies amylin, a fullness hormone your pancreas makes after meals. It lasts about 11 days in the body, so it might only need to be injected once a month. In a small early study, people lost about 8% to 10% of their weight in three months. Bigger studies have only just started, so it is years from approval.
What is ABBV-295?
ABBV-295 (formerly GUB014295, nicknamed GUBamy) is an investigational long-acting analog of amylin, the satiety hormone that the pancreas releases alongside insulin after meals. It was discovered by Gubra, a Danish contract-research and peptide-discovery company in Hørsholm, and is now developed by AbbVie, which licensed global rights in March 2025 for $350 million upfront, up to $1.875 billion in development, commercial and sales milestones, and tiered royalties. AbbVie describes it as specifically activating both amylin and calcitonin receptors, which places it with the dual amylin and calcitonin receptor agonists (DACRAs) such as cagrilintide and petrelintide rather than with amylin-selective drugs such as eloralintide. Gubra formulated it as a neutral-pH solution that it says is compatible with co-formulation with GLP-1 and other incretin drugs. Its defining feature is duration. In Phase 1, ABBV-295's half-life was about 11 days (270 hours in Gubra's single-dose study; 10.7 to 12.3 days in AbbVie's multiple-dose cohorts), compared with about 48 minutes for pramlintide, the only approved amylin analog, which is injected before every major meal. That allowed AbbVie to test weekly, every-other-week and once-monthly schedules in the same study. In the 12- to 13-week multiple-dose cohorts presented at EASD on 30 September 2026 (45 people on ABBV-295, 15 on placebo, mean BMI 29.3, 88% men), mean weight loss was 7.8% to 9.8% on weekly doses, 9.7% every other week and 7.9% monthly, versus about 0.3% on placebo. Nausea affected 33.3% versus 20.0% on placebo, and 4.4% stopped because of GI side effects (0% on placebo). A Phase 2 dose-finding trial in about 360 adults with obesity or overweight (NCT07752979) started in August 2026, with its primary endpoint at week 32. ABBV-295 is not approved anywhere and is available only in AbbVie trials.
What ABBV-295 Is Investigated For
ABBV-295 is being developed for chronic weight management, alone and potentially in combination with incretin drugs. All human data so far come from one Phase 1 study in mostly male adults with a mean BMI under 30. Within that study, the multiple-dose cohorts lost 7.8% to 9.8% of body weight in 12 to 13 weeks, a fast early response for an amylin drug, and the every-other-week (9.7%) and monthly (7.9%) cohorts did about as well as weekly dosing. The case for interest is the combination of an amylin mechanism, which works through different brain pathways than GLP-1 drugs, and an interval long enough to match the monthly GLP-1 drugs in development. The caveats are large. Each regimen had only about nine people on drug, the participants were not a typical obesity-trial population, three months says nothing about where weight loss plateaus, nausea was common (33.3% vs 20.0%), and none of the data are peer-reviewed. The Phase 2 dose-finding trial, with a 32-week endpoint and estimated completion in March 2028, is the first real test.
History & Discovery
ABBV-295 began at Gubra, a company founded in Denmark in 2008 that combines preclinical contract research with its own peptide drug discovery in metabolic and fibrotic disease. Gubra developed GUB014295, which it nicknamed GUBamy, as a long-acting amylin analog formulated at neutral pH so it could later be combined with incretin drugs. The first-in-human study (NCT06144684), run with Quotient Sciences, began in November 2023. Gubra reported the single-dose results on 13 November 2024, including an 11-day half-life that it said supported weekly dosing. On 3 March 2025 AbbVie licensed global rights for $350 million upfront and up to $1.875 billion in milestones plus tiered royalties; regulatory conditions were satisfied on 28 March 2025. On 1 April 2025 Gubra reported interim results from the first multiple-dose cohorts: 2 mg weekly for six weeks produced 7.77% weight loss vs a 1.99% gain on placebo. Under AbbVie the drug became ABBV-295, and the multiple-dose study added cohorts testing every-other-week and monthly schedules at higher doses. AbbVie announced topline results on 9 March 2026 and presented the detailed data at the EASD meeting on 30 September 2026. Meanwhile it started further Phase 1 studies in adults with obesity (November 2025), in women with overweight or obesity (completed August 2026) and in Japanese participants (March 2026), and launched a Phase 2 dose-finding trial on 4 August 2026.
How It Works
When you eat, your pancreas releases amylin along with insulin. Amylin tells the brain you are full and slows how fast food leaves your stomach. ABBV-295 copies amylin but lasts about 11 days instead of minutes, so one injection can work for a week or longer. It acts on different brain pathways than Ozempic-type drugs.
Amylin acts on amylin receptors, which are the calcitonin receptor (CTR) paired with a receptor activity-modifying protein (RAMP), forming the AMY1, AMY2 and AMY3 subtypes. Acting mainly in the area postrema of the hindbrain and in the hypothalamus, amylin signaling ends meals, and it also slows gastric emptying and suppresses glucagon after meals. AbbVie and Gubra describe ABBV-295 as specifically activating amylin and calcitonin receptors, the DACRA profile it shares with cagrilintide and petrelintide; eloralintide is instead selective for the amylin receptor. Neither company has published the sequence or the half-life-extension chemistry in a peer-reviewed paper. What is public is the pharmacokinetics: a half-life of 270 hours (about 11 days) after single doses, 10.7 to 12.3 days with repeated doses, peak levels 24 to 48 hours after injection, and dose-proportional exposure. That half-life is in the same range as petrelintide's (about 10 days in its Phase 1 trials) and vastly longer than pramlintide's 48 minutes. It makes every-other-week and monthly schedules feasible, although a monthly dose still produces larger peaks and troughs than weekly dosing, and peak-related nausea is the main limit on amylin drugs. Gubra designed the drug product as a neutral-pH solution, which it says makes ABBV-295 compatible with future co-formulation with GLP-1 and other incretin drugs in a single injection. By comparison, pramlintide's commercial solution has a pH of about 4.0, and native human amylin tends to aggregate, which is why every amylin drug is an engineered analog.
Evidence Snapshot
Human Clinical Evidence
Preliminary. One first-in-human study (NCT06144684, 76 participants in the multiple-dose part). Single doses (healthy lean and overweight men, mean BMI 26.65): about 3% weight loss over 6 weeks at 3.5 to 6.0 mg vs about +1% on placebo. Multiple-dose Part A (1 or 2 mg weekly for 6 weeks): -7.77% at day 43 on 2 mg vs +1.99% on placebo, in cohorts randomized 6 to 2. Parts 2B and 2C (EASD 2026; 45 on drug, 15 placebo; BMI 27 to 35 at entry): -7.8% to -9.8% at week 12 on weekly doses, -9.7% every other week and -7.9% monthly at week 13, vs about -0.3% on placebo. Additional Phase 1 studies in adults with obesity, in Japanese participants and in women with overweight or obesity are under way or complete without published results. Phase 2 (NCT07752979) is recruiting. No peer-reviewed publication yet.
Animal / Preclinical
No peer-reviewed preclinical paper on ABBV-295 has been published.
Mechanistic Rationale
Strong for the class. Amylin pharmacology is well established through pramlintide (approved since 2005) and the late-stage cagrilintide and petrelintide programs, and amylin-plus-GLP-1 combinations have produced weight loss above 20% in trials. ABBV-295's specific claim, a dosing interval of up to a month, rests on Phase 1 pharmacokinetics in about 60 people.
Research Gaps & Open Questions
What the current literature has not yet settled about ABBV-295:
- 01Peer-reviewed publication of the Phase 1 data, including the molecule's structure and the per-regimen escalation schedules.
- 02Whether monthly dosing holds weight-loss efficacy and tolerability over 32 weeks and beyond, and how side effects differ by regimen.
- 03Efficacy in a typical obesity population: Phase 1 enrolled mostly men with a mean BMI under 30.
- 04Combination with GLP-1 or other incretin drugs, the use most amylin programs are aiming for.
- 05Long-term safety of continuous calcitonin-receptor activation, effects on lean mass, and cardiovascular outcomes.
- 06Performance in type 2 diabetes, which the Phase 2 trial excludes.
Forms & Administration
Investigational subcutaneous injection; the first-in-human study used a 5 mg/mL solution. Phase 1 regimens were dose-escalated to 4, 6 or 14 mg once weekly, 14 mg every other week, or 8 mg once monthly, given for 12 or 13 weeks. AbbVie has not published the escalation schedules. The Phase 2 trial escalates six active arms to undisclosed maintenance doses. Available only within AbbVie clinical trials.
Dosing & Protocols
The ranges below reflect protocols commonly discussed in the literature and by clinicians — not a prescription. Actual dosing for any individual should be determined by a qualified healthcare provider who knows the patient.
Typical Range
Investigational only. Phase 1 single doses reached at least 6.0 mg. Multiple-dose cohorts were escalated to 4, 6 or 14 mg weekly, 14 mg every other week or 8 mg monthly. Phase 2 doses have not been disclosed.
Frequency
Tested once weekly, once every other week and once monthly by subcutaneous injection. Which schedule goes forward will depend on Phase 2.
Timing Considerations
No specific timing requirements: can be administered at any time of day, with or without food, and is not tied to exercise timing. Consistency matters more than the specific clock — dose at roughly the same time each day (or same day each week, for weekly protocols) to keep exposure steady.
Cycle Length
Phase 1 dosing lasted 12 to 13 weeks; the Phase 2 primary endpoint is at week 32 with safety follow-up to about week 52. Like other obesity drugs, it is being developed for long-term use.
Protocol Notes
These are Phase 1 study doses, not use guidance; any use belongs in a clinical trial with clinician supervision. AbbVie has not published the escalation steps, so it is not yet possible to compare total exposure across regimens or tell whether the monthly cohort began with weekly doses. Because the structure is unpublished, any product sold under the ABBV-295, GUB014295 or GUBamy name cannot be verified and should be assumed not to be the investigational drug.
ABBV-295 is not approved by any regulator. The doses listed come from AbbVie and Gubra Phase 1 disclosures and are not prescribing information.
Timeline of Effects
Onset
In Gubra's single-dose study, weight changes appeared from 3 days after dosing. In the first multiple-dose cohorts, 2 mg weekly produced 7.77% loss by day 43.
Peak Effect
Unknown. Weight was still being lost at weeks 12 to 13 in the longest cohorts (7.8% to 9.8%), and no plateau has been reported. The 32-week Phase 2 endpoint will be the first longer look.
After Discontinuation
With a half-life of about 11 days, the drug takes roughly eight weeks to clear. After a single dose, weight loss persisted through the six-week study, and Gubra described weight loss after six weekly doses as similarly sustained during follow-up. Long-term regain has not been studied, but regain after stopping is typical of obesity drugs.
Common Questions
What is ABBV-295?
ABBV-295 is an investigational long-acting amylin analog for obesity, discovered by Gubra as GUB014295 (GUBamy) and licensed to AbbVie in 2025. It activates amylin and calcitonin receptors to increase fullness and slow stomach emptying. It is in Phase 2 and is not approved anywhere.
How does ABBV-295 compare to cagrilintide, petrelintide and eloralintide?
All four are long-acting amylin drugs, but they differ in receptor profile, development stage and dosing interval. Cagrilintide (Novo Nordisk) and petrelintide (Zealand/Roche) are, like ABBV-295, dual amylin and calcitonin receptor agonists; eloralintide (Lilly) is selective for the amylin receptor. Cagrilintide and petrelintide are in late-stage trials with weekly dosing, and petrelintide's half-life is about 10 days, close to ABBV-295's roughly 11. ABBV-295 is the earliest of the group, with 12- to 13-week Phase 1 data only, but it is the one that has already tested every-other-week and monthly injections in people. Weight-loss figures from these programs come from trials of very different lengths and populations, so they cannot be ranked yet; see the amylin comparison page for the late-stage data.
Why does monthly dosing matter for an amylin drug?
Pramlintide, the only approved amylin analog, has a half-life of about 48 minutes and must be injected before each major meal. Long-acting analogs moved the field to weekly shots. Monthly dosing would cut that to 12 injections a year, and would match the monthly GLP-1 drugs in development, such as Pfizer's berobenatide and Amgen's MariTide, which matters if amylin and GLP-1 drugs end up being used together. The catch is nausea: amylin drugs commonly cause it, and a monthly schedule needs a larger dose with bigger peaks and troughs. ABBV-295's monthly cohort lost 7.9% at 13 weeks, similar to weekly dosing, but AbbVie has not broken out side effects by regimen. Pfizer's MET-233i (PF-08653945) is also being engineered for monthly dosing.
How does ABBV-295 compare to semaglutide or tirzepatide?
It works differently. Semaglutide and tirzepatide act on GLP-1 (and, for tirzepatide, GIP) receptors; ABBV-295 acts on amylin and calcitonin receptors in the brainstem. There are no comparative data. ABBV-295's 7.8% to 9.8% loss at 12 weeks comes from about nine people per regimen and cannot be set against 68- and 72-week Phase 3 results for semaglutide (14.9% in STEP 1) or tirzepatide (20.9% on 15 mg in SURMOUNT-1). Amylin drugs are widely expected to be most useful in combination with incretin drugs, and ABBV-295's neutral-pH formulation was designed with that in mind, but no combination has been tested in humans.
What are the side effects of ABBV-295?
In the EASD 2026 data (Parts 2B and 2C of the Phase 1 study), nausea occurred in 33.3% on ABBV-295 vs 20.0% on placebo and diarrhea in 20.0% vs 0%. Decreased appetite, fatigue and headache were also among the most common events. Most GI events were mild (92% of affected participants had nothing worse than mild), 4.4% stopped because of GI side effects vs 0% on placebo, and there were no serious adverse events. In Gubra's single-dose study, nausea and reduced appetite were frequent and vomiting occasional, and rose with dose.
When will ABBV-295 be available?
Not soon. A Phase 2 dose-finding trial (NCT07752979, about 360 participants in the US and Puerto Rico) started in August 2026, with primary completion estimated for March 2028. Phase 3 trials would follow only if Phase 2 succeeds. No approval date can be estimated.
Can I buy ABBV-295 or GUBamy?
No. Its exact structure has not been published in a peer-reviewed paper, so there is no way to verify that anything sold under the ABBV-295, GUB014295 or GUBamy name is the real molecule. Any such product has unknown identity, purity and sterility. The only legitimate access is through an AbbVie clinical trial.
Who ABBV-295 Is NOT For
- •Pregnancy or breastfeeding: no data, and the Phase 1 study required contraception.
- •Insulin-treated diabetes, especially type 1: pramlintide carries a boxed warning for severe hypoglycemia with insulin, and ABBV-295 has not been studied in diabetes; the Phase 2 trial excludes people with diabetes.
- •Severe gastroparesis or other GI motility disorders: amylin drugs slow gastric emptying.
- •Recent heart attack, stroke, unstable angina or heart-failure hospitalization (within 180 days): excluded from the Phase 2 trial.
- •Known hypersensitivity to amylin analogs or the formulation.
Drug & Supplement Interactions
No interaction studies have been published. Based on the amylin class, slowed gastric emptying can delay the absorption of oral medicines, which matters most for drugs whose timing or levels are critical. Combining amylin drugs with insulin raises the risk of severe hypoglycemia, which is why pramlintide's label requires cutting mealtime insulin by 50% when starting it; ABBV-295 has not been tested with insulin or other glucose-lowering drugs. Combination with GLP-1 drugs is the class's main commercial strategy, and Gubra designed ABBV-295's formulation for it, but no human combination data exist. The Phase 2 trial excludes anyone who has used a weight-management drug in the prior 180 days.
Safety Profile
Common Side Effects
Cautions
- • Investigational: not approved by any regulator and available only in AbbVie trials
- • Very small dataset: 45 people on drug in the cohorts presented at EASD 2026, 88% men, mean BMI 29.3, no people with diabetes
- • 4.4% stopped because of GI side effects vs 0% on placebo
- • Amylin drugs combined with insulin can cause severe hypoglycemia (a boxed warning on pramlintide); ABBV-295 has not been studied with insulin
- • Long-term effects of continuous calcitonin-receptor activation have not been characterized
What We Don't Know
Everything beyond 13 weeks is unknown: where weight loss plateaus, long-term safety, effects on lean mass, and cardiovascular outcomes. Side effects by dosing regimen, including whether monthly dosing brings more nausea, have not been reported. There are no published data in women at scale, in people with BMI above 35, or in type 2 diabetes, and no human data on combination with GLP-1 drugs.
Legal Status
United States
Investigational and not FDA-approved. The Phase 2 trial is recruiting at US and Puerto Rico sites. It is not legally available through compounding pharmacies, telehealth or research-chemical suppliers.
International
Not approved in any country. AbbVie holds global development and commercialization rights.
Sports & Competition
Not named on the WADA Prohibited List, but WADA's S0 category bans at all times any substance with no current approval from a government health authority for human therapeutic use, including drugs in clinical development. That covers ABBV-295 and other unapproved amylin analogs.
Regulatory status changes over time. Verify current local rules with a qualified professional.
Myths & Misconceptions
Myth
ABBV-295 produced 10% weight loss in a monthly shot.
Reality
The monthly cohort lost 7.9% at 13 weeks. The 9.7% figure was the every-other-week cohort, and the 9.8% top figure came from weekly dosing. Each regimen included only about nine people on drug.
Myth
ABBV-295 has already been shown to work as well as GLP-1 drugs.
Reality
It has only 12- to 13-week Phase 1 data in about 60 people, and it has never been compared with a GLP-1 drug. Its value may lie as much in combination with incretin drugs as alone.
Myth
Amylin drugs don't cause nausea.
Reality
Nausea affected 33.3% on ABBV-295 vs 20.0% on placebo in the EASD 2026 data, and nausea is the main dose-limiting side effect across the amylin class.
Published Research
10 studiesAmylin Analogs: The Next Major Class of Weight Loss Therapy: A Review of Experimental Data and Early-Phase Clinical Trials (Diabetes Obes Metab 2026)
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Petrelintide for Weight Management: Two Randomized, Controlled Phase 1 Trials (Diabetes Obes Metab 2026)
Long-acting amylin-related peptides as therapies for obesity and type 2 diabetes (Peptides 2026)
AbbVie Presents Detailed Phase 1 Data for ABBV-295, a Long-Acting Amylin Analog, Demonstrating Favorable Tolerability and Pharmacokinetic Profile at EASD 2026
The main data source: 60 participants (45 on drug) in Parts 2B and 2C; weight loss of 7.8% to 9.8% on weekly doses at week 12, 9.7% every other week and 7.9% monthly at week 13 vs about 0.3% on placebo; half-life 10.7 to 12.3 days; nausea 33.3% vs 20.0%; GI discontinuation 4.4% vs 0%.
AbbVie Announces Positive Topline Results from a Phase 1 Multiple Ascending Dose Study of ABBV-295, a Long-Acting Amylin Analog, in Adults (March 2026)
AbbVie and Gubra Announce License Agreement to Develop an Amylin Analog for the Treatment of Obesity (March 2025)
Gubra announces positive GUBamy Phase 1 SAD data (November 2024)
First human data: in healthy lean and overweight men, a single dose gave a half-life of 270 hours (11 days) and about 3% weight loss over 6 weeks at 3.5 to 6.0 mg, with dose-dependent nausea, reduced appetite and occasional vomiting.
Gubra announces positive GUBamy Phase 1 interim MAD results (April 2025)
ClinicalTrials.gov NCT06144684 — First-in-human SAD/MAD study of GUB014295
ClinicalTrials.gov NCT07752979 — Phase 2 dose-finding study of ABBV-295 in adults with obesity or overweight
Quick Facts
- Class
- Amylin Receptor Agonist
- Tier
- C
- Evidence
- Preliminary
- Safety
- Limited Data
- Updated
- Oct 2026
- Citations
- 10PubMed
Also known as
Tags
Peptide Families
Related Goals
Evidence Score
Clinical Trials
View Clinical TrialsLinks to ClinicalTrials.gov for reference. Listing does not imply endorsement.