Recent Updates
Recently added Catalysts

AZP-3601

Phase 1

Chronic Hypoparathyroidism | Small molecule | Endocrine |AstraZeneca PLC|Last Updated: Sep 8, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment132

FDA Designations

No designations recorded

Clinical trial landscape

AZP-3601 · 1 trial · 1 indication

Phase 1 1
NCT05239221AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With HypoparathyroidismChronic Hypoparathyroidism
COMPLETED132 Analytics
PHASE1COMPLETED
AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism
Chronic HypoparathyroidismUnlock trial analytics

Study Endpoints

Primary Endpoints

Treatment Emergent Adverse Events (TEAEs)
Up to 2 weeks in Part A and Part B, and up to 3 months in Part C

Number of Treatment Emergent Adverse Events (TEAEs), as assessed by medDRA (v25).

Secondary Endpoints

Observed Maximum Concentration (Cmax) - Part A
24 hours
Observed Maximum Concentration (Cmax) - Part B
Day 1, Day 14
Observed Maximum Concentration (Cmax) - Part C
Day 1, Day 14, Day 28, Day 84
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZP-3601EXPERIMENTALsubcutaneous (sc) administration once daily
Placebo (Parts A and B)PLACEBO_COMPARATORsubcutaneous (sc) administration once daily

Interventions

NameTypeDescription
AZP-3601DRUGLyophilized powder of AZP-3601 to be reconstituted with water for injection before injection
PlaceboDRUGSaline solution visually matching active medication
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites2

Main inclusion criteria * Part A: healthy male volunteers aged 18 to 60 years old inclusive with a body mass index of 19 to 28 kg/m2 * Part B: healthy male and female volunteers (non-child bearing potential) aged 18 to 60 years inclusive with a Body mass index of 19 to 28 kg/m2 * Part C: 1. Male...

Countries:HungaryNetherlands
Unlock Eligibility Criteria

Frequently asked questions about AZP-3601

What is AZP-3601 used for?

AZP-3601 is an investigational small molecule being developed for the treatment of chronic hypoparathyroidism, a condition characterized by low levels of parathyroid hormone. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing AZP-3601?

AZP-3601 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials for chronic hypoparathyroidism.

What phase is AZP-3601 in?

AZP-3601 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 1 trial has been completed, and the drug remains under investigation for chronic hypoparathyroidism.

What clinical trials is AZP-3601 in?

AZP-3601 has one completed Phase 1 clinical trial, identified as NCT05239221. This study was a single ascending dose and multiple ascending dose trial conducted in healthy subjects and patients with hypoparathyroidism, enrolling 132 participants across Hungary and the Netherlands.

Is AZP-3601 the same as any other drug?

AZP-3601 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being studied under the clinical trial identifier NCT05239221 for chronic hypoparathyroidism.