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BMN 333

Phase 2

Achondroplasia | Small molecule | Rare Disease |BioMarin Pharmaceutical Inc.|Last Updated: Aug 21, 2026

Target and mechanism

Molecular targetC-type Natriuretic Peptide (CNP)
Target classPeptide
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

BMN 333 · 1 trial · 1 indication

Phase 2 1
NCT07441876Study to Evaluate the Efficacy and Safety of BMN 333 Versus Vosoritide in Children With AchondroplasiaAchondroplasia
RECRUITING160 Analytics
PHASE2RECRUITING
Study to Evaluate the Efficacy and Safety of BMN 333 Versus Vosoritide in Children With Achondroplasia
AchondroplasiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 2: Predicted Annualized Growth Velocity (AGV) at Week 52 (based on AGV at Weeks 26, 39, and 52 [available cumulative data]
52 weeks
Phase 3: Annualized Growth Velocity (AGV) at Week 52
52 weeks

Secondary Endpoints

Phase 2: AGV at Weeks 26 and 52
26 and 52 weeks
Phase 2: Change from Baseline in standing height
26 and 52 weeks
Phase 2: Change from Baseline in height Z-score
26 and 52 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 2: Low DoseEXPERIMENTALParticipants will be randomized to receive different dose levels of BMN 333
Phase 2: Medium DoseEXPERIMENTALParticipants will be randomized to receive different dose levels of BMN 333
Phase 2: High DoseEXPERIMENTALParticipants will be randomized to receive different dose levels of BMN 333
Phase 2: VosoritideACTIVE_COMPARATORweight band dosing, Modified recombinant human C-type natriuretic peptide Vosoritide
Phase 3: BMN 333 at selected dose after Phase 2EXPERIMENTAL -
Phase 3: VosoritideACTIVE_COMPARATORweight band dosing, Modified recombinant human C-type natriuretic peptide Vosoritide

Interventions

NameTypeDescription
BMN 333DRUGAdministration: Weekly subcutaneous injection
Vosoritide Injection [Voxzogo]DRUGAdministration: Daily subcutaneous injection
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Eligibility Criteria

Age Range2 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: 1. Participants must be aged ≥ 2 to \< 11 years (Phase 2) or ≥ 2 to \< 18 years (Phase 3), at the time of signing the informed consent 2. Participants must have ACH (confirmed by documented genetic testing) and open epiphyses 3. Are Tanner Stage I (Phase 2) or any Tanner stage (...

Countries:United StatesAustraliaCanadaItalyJapanPolandRomaniaSouth KoreaUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 21, 2026NCT07441876lastUpdatePostDate: changed
LOWAug 21, 2026NCT07441876lastUpdatePostDate: changed
LOWJul 24, 2026NCT07441876lastUpdatePostDate: changed
LOWJul 24, 2026NCT07441876lastUpdatePostDate: changed
LOWJul 6, 2026NCT07441876startDate: changed
LOWJul 6, 2026NCT07441876startDate: changed

Frequently asked questions about BMN 333

What is BMN 333 used for?

BMN 333 is an investigational small molecule being developed for achondroplasia, a rare genetic disorder affecting bone growth. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does BMN 333 target?

BMN 333 targets C-type Natriuretic Peptide (CNP), a peptide involved in bone growth regulation. By modulating this pathway, the drug aims to address the underlying growth deficiency in achondroplasia.

Who makes BMN 333?

BMN 333 is being developed by BioMarin Pharmaceutical Inc., a biopharmaceutical company focused on rare diseases. BioMarin trades on the Nasdaq under the ticker symbol BMRN.

What phase is BMN 333 in?

BMN 333 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies and is still undergoing clinical trials to evaluate its safety and efficacy.

What clinical trials is BMN 333 in?

BMN 333 is being studied in a Phase 2 clinical trial with the identifier NCT07441876. This active, recruiting study evaluates the efficacy and safety of BMN 333 compared to vosoritide in children with achondroplasia, with an enrollment target of 160 participants.

Is BMN 333 the same as vosoritide?

No, BMN 333 is not the same as vosoritide. In the ongoing Phase 2 trial, BMN 333 is being compared against vosoritide, which serves as the active control. Both target the CNP pathway but are distinct investigational agents.