AGA2115
An investigational treatment for Osteogenesis Imperfecta.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify AGA2115 wherever you encounter it, plus the key facts at a glance.
- Generic name
- AGA2115
- Development codes
- AGA2115, AGA-2115
- Drug class
- Bispecific antibody (anti-sclerostin and anti-DKK1)
- Manufacturer
- Angitia Biopharmaceuticals
- How it's taken
- Injection under the skin, in trials only
An investigational injection from Angitia Biopharmaceuticals that aims to build bone in osteogenesis imperfecta by blocking 2 brakes on bone formation at once, sclerostin and DKK1 [1].
It is in the Phase 2 IDUN trial for adults, which is recruiting at US sites [4]. It is not FDA approved, and no results in people with OI have been published.
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How AGA2115 works
Bone-building cells called osteoblasts are held in check by proteins including sclerostin and Dickkopf-1 (DKK1), which both damp down the Wnt signal that tells those cells to make bone. AGA2115 is a bispecific antibody, a single antibody built to grab 2 targets, that blocks sclerostin and DKK1 together [1]. The aim is to raise bone mass and strength in OI, where faulty type I collagen makes bones fragile. It does not repair the collagen gene itself.
Clinical trial results
IDUN (NCT07062588) is a randomized, double-blind, placebo-controlled Phase 2 trial testing 3 dose regimens in about 80 adults aged 18 to 75 with OI type I, III or IV and a confirmed COL1A1 or COL1A2 variant. Its main measure is the percent change in lumbar spine bone mineral density (BMD) after 12 months, followed by 12 months in which everyone receives AGA2115.
It requires a bone density T-score of -1.0 or lower at the spine or hip. It excludes people who had a bisphosphonate in the past 6 months, teriparatide, abaloparatide, hormone replacement therapy, strontium ranelate or another trial drug in the past 12 months, denosumab in the past 2 years, or any anti-sclerostin antibody, such as romosozumab, setrusumab or blosozumab, at any time.
ClinicalTrials.gov lists 7 US sites as recruiting, including Yale, Indiana University, Ohio State and OHSU, with primary completion estimated in November 2027 [4].
EIR (NCT07557446) is a randomized Phase 2 trial in China in about 48 people aged 12 to 75, measuring safety. It is open-label, meaning everyone knows what they receive, and its comparison groups get no drug until the second year. It began in July 2026 [6].
In the Phase 1 study in healthy adults, the highest repeat dose raised lumbar spine BMD by an average of 14.4% and total hip BMD by 3.6% after 6 months [2]. Those were healthy volunteers, not people with OI.
Main registered trial: NCT07062588 on ClinicalTrials.gov. Check it for the current status, sites and contacts before asking about enrollment.
Side effects and safety
In a Phase 1 study of 72 healthy adults, Angitia reported that AGA2115 was safe and well tolerated at all doses tested, with side effects balanced between drug and placebo and no treatment-related serious side effects [2]. Angitia did not name specific side effects. No safety data in people with OI have been published. No clinical hold has been reported.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking AGA2115
Given as an injection under the skin in the Phase 2 trials [4] [6]. How often it is given in Phase 2 has not been disclosed; in Phase 1, repeat-dose groups received doses every 4 weeks for 3 doses [2].
Development history
Angitia completed a Phase 1 study of AGA2115 in 72 healthy adults in October 2024 [5] and presented the data at ASBMR in September 2025 [2]. The FDA granted orphan drug and rare pediatric disease designations, and the European Medicines Agency granted orphan designation [3]. Angitia announced on January 12, 2026 that the first participant in IDUN had been dosed [1]. Angitia has not announced filing plans.
Explore Osteogenesis Imperfecta trials
Common questions about AGA2115
▸What is AGA2115?
An investigational injection from Angitia Biopharmaceuticals that aims to build bone in osteogenesis imperfecta by blocking 2 brakes on bone formation at once, sclerostin and DKK1 [1]. It is in the Phase 2 IDUN trial for adults, which is recruiting at US sites [4]. It is not FDA approved, and no results in people with OI have been published.
▸How does AGA2115 work?
Bone-building cells called osteoblasts are held in check by proteins including sclerostin and Dickkopf-1 (DKK1), which both damp down the Wnt signal that tells those cells to make bone. AGA2115 is a bispecific antibody, a single antibody built to grab 2 targets, that blocks sclerostin and DKK1 together [1]. The aim is to raise bone mass and strength in OI, where faulty type I collagen makes bones fragile. It does not repair the collagen gene itself.
▸What are the side effects of AGA2115?
In a Phase 1 study of 72 healthy adults, Angitia reported that AGA2115 was safe and well tolerated at all doses tested, with side effects balanced between drug and placebo and no treatment-related serious side effects [2]. Angitia did not name specific side effects. No safety data in people with OI have been published. No clinical hold has been reported.
▸How is AGA2115 taken?
▸Is AGA2115 FDA approved?
AGA2115 is currently in phase 2 clinical trials for Osteogenesis Imperfecta. It has not yet received FDA approval.
▸What is AGA2115 and how does it work for osteogenesis imperfecta?
An investigational antibody that blocks sclerostin and DKK1, 2 proteins that slow bone building.
Goal: raise bone density and strength; it does not fix the collagen gene behind OI.
How it is given: an injection under the skin in the Phase 2 trials.
Source: Angitia Biopharmaceuticals release, January 12, 2026; ClinicalTrials.gov NCT07062588.
▸Who can join the IDUN trial of AGA2115?
Adults 18 to 75 with OI type I, III or IV and a confirmed COL1A1 or COL1A2 variant.
Bone density: a T-score of -1.0 or lower at the spine or hip.
Not eligible: a bisphosphonate in the past 6 months; teriparatide, abaloparatide, hormone replacement therapy, strontium ranelate or another trial drug in the past 12 months; denosumab in the past 2 years; or any anti-sclerostin antibody ever.
Where: ClinicalTrials.gov lists 7 US sites as recruiting, among 26 sites in all.
Source: ClinicalTrials.gov NCT07062588, updated November 4, 2026.
▸How is AGA2115 different from romosozumab or setrusumab?
AGA2115 blocks sclerostin and DKK1; the IDUN trial's eligibility list names romosozumab, setrusumab and blosozumab as anti-sclerostin antibodies.
Trials: IDUN excludes anyone who has ever had an anti-sclerostin antibody.
Comparison: no trial has compared AGA2115 with these drugs.
Source: Angitia Biopharmaceuticals release, January 12, 2026; ClinicalTrials.gov NCT07062588.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Angitia Biopharmaceuticals · 2026-01-12. Angitia Biopharmaceuticals announces dosing of first participant in Phase 2 IDUN trial of AGA2115 for the treatment of osteogenesis imperfecta. https://www.angitiabio.com/news/item?id=70
- Angitia Biopharmaceuticals (GlobeNewswire, BioSpace copy) · 2025-09-08. Angitia Biopharmaceuticals presents first-in-human data on AGA2115 for osteogenesis imperfecta at ASBMR 2025. https://www.biospace.com/press-releases/angitia-biopharmaceuticals-presents-first-in-human-data-on-aga2115-for-osteogenesis-imperfecta-at-asbmr-2025
- Angitia Biopharmaceuticals (BioSpace wire copy) · 2025-06-12. Angitia Biopharmaceuticals Announces Topline Results from First in Human Study of AGA2115, A Bispecific Antibody for the Treatment of Osteogenesis Imperfecta. https://www.biospace.com/press-releases/angitia-biopharmaceuticals-announces-topline-results-from-first-in-human-study-of-aga2115-a-bispecific-antibody-for-the-treatment-of-osteogenesis-imperfecta
- ClinicalTrials.gov. Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN). https://clinicaltrials.gov/study/NCT07062588
- ClinicalTrials.gov. A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers. https://clinicaltrials.gov/study/NCT06086613
- ClinicalTrials.gov. A Dose REgimen-Finding Study of AGA2115 in Chinese Patients With Osteogenesis ImpeRfecta (EIR). https://clinicaltrials.gov/study/NCT07557446