A Study of TYRA-300 in Children With Achondroplasia

This study, called BEACH301, is looking at a drug called TYRA-300 for children with achondroplasia. Achondroplasia is a genetic condition that affects bone growth. The main goals are to see if TYRA-300 is safe and well-tolerated, and to find the right dose. Researchers will also look at how much children grow while taking the drug. You may be able to join if you are a child between 3 and 10 years old with a specific genetic diagnosis of achondroplasia (FGFR3 G380R). The study is currently unclear about its recruitment status and plans to enroll 92 participants.

Study design: This is a Phase 2, multicenter, open-label, dose-escalation study. It will involve three groups of children and aims to enroll 92 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The study will assess treatment-related side effects for up to 12 months and changes in growth velocity at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

A Study of TYRA-300 in Children With Achondroplasia: BEACH301

Recruiting

PHASE2Ages 3–10InterventionalTreatment

Tyra Biosciences, Inc

~92 participants

Updated 2026-08-31 on ClinicalTrials.gov

What's tested:TYRA-300 0.125 mg/kgTYRA-300 0.25 mg/kgTYRA-300 0.375 mg/kgTYRA-300 0.50 mg/kgTYRA-300 0.625 mg/kg

At a glance

Recruiting sites

25 of 25 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence of treatment-related adverse events as assessed by CTCAE v5.0

Measured over Up to 12 months

+1 more outcome measured

Conditions

Achondroplasia

Where it's being run

25 sites across 20 states

Maryland2

Missouri2

Texas2

Ontario2

Greater London2

California1

Colorado1

Delaware1

Study leadership

Doug Warner, MD · STUDY_CHAIR · Tyra Biosciences

Who to contact

Suzanne Lopez

[email protected]

(619) 728-4805

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged 3 to 10 years old (inclusive) at the time of consent.

Informed consent provided by parent(s) or legal guardian(s). As study participants are less than 18 years old, participants are willing and able to provide written assent (where applicable and required).

Molecular diagnosis of achondroplasia (FGFR3 G380R).

Radiographically confirmed open growth plates at Screening, as determined by bone age X-ray.

Able to stand and ambulate independently.

Able to take oral medication.

Sentinel Safety Cohort only: aged 5 to 10 years old (inclusive).

Cohort 1 only: aged 3 to 10 years old (inclusive) and are naive to prior growth accelerating therapy.

Cohort 2 only: aged 3 to 10 years old (inclusive) and have received prior growth accelerating therapy.

Exclusion

Presence or history of any concurrent disease or condition that would interfere with study participation, safety evaluations, or any uncontrolled or untreated condition that could impact pediatric growth.

Diagnosis of endocrine condition that alters calcium/phosphate homeostasis.

Prior limb lengthening surgery or planned or expected to have limb lengthening surgery while enrolled in the study.

Taking medications that are strong inhibitors or inducers of cytochrome P450 (Cyp) 3A4.

History or current evidence of corneal or retinal disorder/keratopathy.

Presence of guided growth hardware/8 plates. Planned or anticipated orthopedic surgeries.

What this trial measures

Incidence of treatment-related adverse events as assessed by CTCAE v5.0Up to 12 months
Change from baseline in annualized growth velocity (Cohort 1)12 months

Trialytics