A Phase 2 interventional study of TYRA-300 0.125 mg/kg and TYRA-300 0.25 mg/kg in Achondroplasia, sponsored by Tyra Biosciences, Inc. Recruiting at 25 sites in 8 countries. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Tyra Biosciences, Inc · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety, tolerability, and identify potentially effective dose(s) of TYRA-300 in children with achondroplasia with open growth plates.
This is a Phase 2, multicenter, open-label, dose-escalation study to determine the safety, tolerability, and identify potentially effective dose(s) of TYRA-300, a fibroblast growth factor receptor (FGFR)-3 selective tyrosine kinase inhibitor, in children 3 to 10 years of age with achondroplasia with open growth plates that will examine three cohorts of children: the Sentinel Safety Cohort, Cohort 1, and Cohort 2.
47 studies on the registry are indexed under Achondroplasia; 13 are open to participants now.
This study's planned enrollment of 92 is above the median of 74 across 28 interventional studies indexed under Achondroplasia.
Browse Achondroplasia studies →Tyra Biosciences, Inc is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months.
Drug: TYRA-300 0.125 mg/kg
TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months.
Drug: TYRA-300 0.25 mg/kg
TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months.
Drug: TYRA-300 0.375 mg/kg
TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months.
Drug: TYRA-300 0.50 mg/kg
TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months.
Drug: TYRA-300 0.625 mg/kg
Drug page: Dabogratinib
Initial dose level of TYRA-300 per protocol, subsequent dose level escalations will occur based on criteria outlined in the protocol.
Drug page: Dabogratinib
Subsequent dose level escalations will occur based on criteria outlined in the protocol.
Drug page: Dabogratinib
Subsequent dose level escalations will occur based on criteria outlined in the protocol.
Drug page: Dabogratinib
Subsequent dose level escalations will occur based on criteria outlined in the protocol.
Drug page: Dabogratinib
Subsequent dose level escalations may occur based on criteria outlined in the protocol.
Incidence of treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 12 months
Change from baseline in annualized growth velocity (Cohort 1)
Time frame: 12 months
Change from baseline in annualized growth velocity (Cohort 1)
Time frame: 6 months
Change from baseline in height z-score (Cohort 1)
Time frame: 6 and 12 months
Pharmacokinetics: maximum plasma concentration (Cmax)
Time frame: 15 days
Pharmacokinetics: time to reach maximum plasma concentration (Tmax)
Time frame: 15 days
Pharmacokinetics: area under the plasma concentration-time curve (AUC)
Time frame: 15 days
Pharmacokinetics: half-life of TYRA-300 (t1/2)
Time frame: 15 days
Pharmacokinetics: apparent total clearance (CL/F)
Time frame: 15 days
Pharmacokinetics: apparent volume of distribution (Vd/F)
Time frame: 15 days
Change from baseline in annualized growth velocity (Cohort 2)
Time frame: 6 and 12 months
Change from baseline in height z-score (Cohort 2)
Time frame: 6 and 12 months
Change from baseline in standing height (cm)
Time frame: 6 and 12 months
Change from baseline in sitting height (cm)
Time frame: 6 and 12 months
Change from baseline in upper and lower arm length (cm)
Time frame: 6 and 12 months
Change from baseline in tibial length (cm)
Time frame: 6 and 12 months
Change from baseline in femur length (cm)
Time frame: 6 and 12 months
Change from baseline in arm span proportionality (arm span/height ratio)
Time frame: 6 and 12 months
Change from baseline in upper segment/lower segment ratio
Time frame: 6 and 12 months
Change from baseline in elbow extension
Time frame: 6 and 12 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dabogratinib
Tyra Biosciences, Inc