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TYRA-300 /kg

Phase 2

Achondroplasia | Small molecule | Rare Disease |Tyra Biosciences, Inc.|Last Updated: Jul 31, 2026

Target and mechanism

Molecular targetFGFR3
Target classReceptor
ModalitySmall molecule

Also known as TYRA-300, TYRA-300 60mg

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment92

FDA Designations

No designations recorded

Clinical trial landscape

TYRA-300 /kg · 1 trial · 1 indication

Phase 2 1
NCT06842355A Study of TYRA-300 in Children With Achondroplasia: BEACH301Achondroplasia
RECRUITING92 Analytics
PHASE2RECRUITING
A Study of TYRA-300 in Children With Achondroplasia: BEACH301
AchondroplasiaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Change from baseline in annualized growth velocity (Cohort 1)
6 months
Change from baseline in height z-score (Cohort 1)
6 and 12 months
Pharmacokinetics: maximum plasma concentration (Cmax)
15 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TYRA-300 0.125 mg/kgEXPERIMENTALTYRA-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.
TYRA-300 0.25 mg/kgEXPERIMENTALTYRA-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.
TYRA-300 0.375 mg/kgEXPERIMENTALTYRA-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.
TYRA-300 0.50 mg/kgEXPERIMENTALTYRA-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.

Interventions

NameTypeDescription
TYRA-300 0.125 mg/kgDRUGInitial dose level of TYRA-300 per protocol, subsequent dose level escalations will occur based on criteria outlined in the protocol.
TYRA-300 0.25 mg/kgDRUGSubsequent dose level escalations will occur based on criteria outlined in the protocol.
TYRA-300 0.375 mg/kgDRUGSubsequent dose level escalations will occur based on criteria outlined in the protocol.
TYRA-300 0.50 mg/kgDRUGSubsequent dose level escalations will occur based on criteria outlined in the protocol.
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Eligibility Criteria

Age Range3 Years to 10 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * 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 ...

Countries:United StatesAustraliaCanadaFranceNetherlandsSpainSwedenUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJul 31, 2026NCT06842355lastUpdatePostDate: changed
LOWJul 31, 2026NCT06842355lastUpdatePostDate: changed
LOWJul 30, 2026NCT06842355lastUpdatePostDate: changed
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LOWJul 13, 2026NCT06842355lastUpdatePostDate: changed
LOWJul 13, 2026NCT06842355lastUpdatePostDate: changed
LOWJun 30, 2026NCT06842355lastUpdatePostDate: changed
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LOWJun 30, 2026NCT06842355lastUpdatePostDate: changed
LOWJun 9, 2026NCT06842355lastUpdatePostDate: changed
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LOWJun 5, 2026NCT06842355lastUpdatePostDate: changed
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LOWJun 5, 2026NCT06842355lastUpdatePostDate: changed
LOWMay 26, 2026NCT06842355primaryCompletionDate: changed

Frequently asked questions about TYRA-300 /kg

What is TYRA-300 used for?

TYRA-300 is an investigational small molecule being studied for low-grade non-muscle invasive bladder cancer (NMIBC), locally advanced urothelial carcinoma, and achondroplasia. It is in Phase 1 and Phase 2 clinical trials for these conditions. The drug is not yet approved and remains in clinical development.

What does TYRA-300 target?

TYRA-300 targets FGFR3, a receptor involved in cell growth and division. By inhibiting FGFR3, the drug aims to interfere with signaling pathways that can drive tumor growth in cancers with FGFR3 gene alterations, as well as address skeletal growth issues in achondroplasia.

Who makes TYRA-300?

TYRA-300 is being developed by Tyra Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TYRA. The company is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.

What phase is TYRA-300 in?

TYRA-300 is in Phase 1 and Phase 2 clinical trials. A Phase 1 study is evaluating the drug in advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations. Two Phase 2 studies are assessing it in achondroplasia and low-grade non-muscle invasive bladder cancer.

What clinical trials is TYRA-300 in?

TYRA-300 is being studied in three clinical trials: NCT05544552, a Phase 1 trial in advanced urothelial carcinoma and other solid tumors with FGFR3 alterations; NCT06842355, a Phase 2 trial in children with achondroplasia; and NCT06995677, a Phase 2 trial in low-grade non-muscle invasive bladder cancer.

Is TYRA-300 the same as TYRA-300 60mg?

Yes, TYRA-300 is also known as TYRA-300 60mg, TYRA-300 0.125 mg/kg, and TYRA-300 /kg. These names refer to the same investigational drug being developed by Tyra Biosciences for FGFR3-related conditions.