Neurocrine Biosciences

Neurocrine Biosciences works on 5 rare diseases tracked on Trial Friend, including Congenital Adrenal Hyperplasia, Friedreich Ataxia, Huntington Disease and 2 more, with 9 recruiting clinical trials and 1 FDA-approved rare disease drug.

Neurocrine Biosciences develops treatments for rare neurological, neuroendocrine, and neuropsychiatric disorders. The company markets INGREZZA (valbenazine) for tardive dyskinesia and Huntington's chorea, CRENESSITY (crinecerfont), approved in December 2024 as the first non-steroidal therapy for classic congenital adrenal hyperplasia, and VYKAT XR (diazoxide choline), the first FDA-approved medicine for hyperphagia in Prader-Willi syndrome, added through the $2.9 billion acquisition of Soleno Therapeutics that closed in May 2026.

Type
Diversified Pharma
Ticker
NBIX
Headquarters
San Diego, United States
Founded
1992
9
Active Rare Disease Trials
1
Approved Rare Disease Drugs
5
Rare Diseases in Portfolio
34
Years Active

Neurocrine Biosciences Drug Pipeline

Neurocrine Biosciences has 9 active clinical trials across 2 development stages, with 9 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.

Note: This pipeline includes all of Neurocrine Biosciences's active interventional trials, not only those targeting rare diseases. We show the full pipeline because a company's broader research activity, therapeutic expertise, and development infrastructure directly shape its ability to advance rare disease programs. A strong overall pipeline often signals deeper clinical operations, faster enrollment capabilities, and greater commitment to bringing new treatments to patients.

Understand Neurocrine Biosciences's pipeline
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2
Phase 22 trials
7
Phase 37 trials
Major Depressive Disorder
Recruiting
Major Depressive Disorder
Recruiting
Major Depressive Disorder
Recruiting
Major Depressive Disorder
Recruiting

Neurocrine Biosciences Clinical Trials (9)

Active and recruiting clinical trials sponsored by Neurocrine Biosciences, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.

Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.

Ask about Neurocrine Biosciences's trials
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RECRUITINGPHASE2Recently updatedNCT07536269

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old

Intervention: Crinecerfont

The main objective of this study is to assess the safety and tolerability of crinecerfont in pediatric participants 3 months to \<4 years of age with CAH.

Ages 3 Months - 47 Months11 locations
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ACTIVE NOT RECRUITINGPHASE2Recently updatedNCT07187375

Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old

Intervention: Crinecerfont

The main objective for this study is to evaluate the pharmacokinetics (PK) of crinecerfont in pediatric participants 0 to \<2 years of age with congenital adrenal hyperplasia (CAH).

Ages 0 Years - 23 Months3 locations
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RECRUITINGPHASE3Recently updatedNCT06911112

NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Intervention: NBI-1065845, Placebo

Major Depressive Disorder

The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.

Ages 18 Years+39 locations
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RECRUITINGPHASE3Recently updatedNCT06963021

NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Intervention: NBI-1065845, Placebo

Major Depressive Disorder

The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.

Ages 18 Years+35 locations
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RECRUITINGPHASE3Recently updatedNCT07196501

A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Intervention: NBI-1065845, Placebo

Major Depressive Disorder

The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

Ages 18 Years+60 locations
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RECRUITINGPHASE3Recently updatedNCT06966401

Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Intervention: NBI-1065845

Major Depressive Disorder

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Ages 18 Years+106 locations
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ACTIVE NOT RECRUITINGPHASE3Updated a few months agoNCT04490915

Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

Intervention: Crinecerfont, Placebo

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 24-week randomized, double-blind, placebo-controlled period, followed by 1 year of active treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).

Ages 18 Years+70 locations
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Neurocrine Biosciences FDA-Approved Drugs (1)

Medications developed or marketed by Neurocrine Biosciences that have received U.S. Food and Drug Administration approval. Drug data is sourced from the openFDA database and includes brand names, generic names, approval dates, and matched rare disease indications. Where a drug treats a condition covered by Trial Friend, the disease name links directly to that disease page.

Drug NameBrand NameRare DiseasesApproval Date
VALBENAZINEINGREZZA
oral
Apr 11, 2017

Neurocrine Biosciences Trial Locations

Neurocrine Biosciences clinical trials are running at 388 sites in 29 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.

United States
173▼
Bulgaria
20▼
Italy
18▼
Poland
17▼
Slovakia
13▼
United Kingdom
13▼
Canada
12▼
Germany
11▼
France
11▼
Belgium
9▼
Latvia
8▼
Spain
8▼

Rare Disease Focus Areas (5)

Diseases targeted by Neurocrine Biosciences's clinical trial and drug development programs

Congenital Adrenal HyperplasiaEndocrine & Hormonal

Congenital adrenal hyperplasia comprises rare autosomal recessive disorders of cortisol synthesis. Over 90% result from 21-hydroxylase deficiency. Salt-wasting and virilizing forms present with differ...

Prevalence: 1 in 10,000 to 25,000 people; higher in certain populations
Friedreich AtaxiaNeurological & Neuromuscular

Friedreich ataxia is an autosomal recessive neurodegenerative disease causing progressive damage to the nervous system, resulting in loss of coordination (ataxia), weakness, and heart problems. The co...

Prevalence: 1 in 50,000 people
Huntington DiseaseNeurological & Neuromuscular

Huntington disease is an autosomal dominant neurodegenerative disorder caused by an expanded CAG trinucleotide repeat in the huntingtin gene. The progressive disease causes movement problems, cognitiv...

Prevalence: 5-10 per 100,000 people of European descent; lower in other populations
Multiple SclerosisAutoimmune & Inflammatory

Multiple sclerosis is a chronic autoimmune disease where the immune system attacks the protective myelin sheath surrounding nerve fibers in the brain and spinal cord. This disrupts communication betwe...

Prevalence: Approximately 1 million people in the U.S.; about 1 in 300. Worldwide, an estimated 2.8 million people live with MS.
Prader-Willi SyndromeNeurological & Neuromuscular

Prader-Willi Syndrome is a rare genetic disorder affecting chromosome 15 that results in weak muscle tone, low hormone levels, incomplete sexual development, intellectual disability, and a constant fe...

Prevalence: Approximately 1 in 10,000 to 30,000 live births

Patient Resources

Organizations and resources related to Neurocrine Biosciences's rare disease focus areas

Frequently Asked Questions About Neurocrine Biosciences

Common questions about Neurocrine Biosciences's rare disease programs, clinical trials, and treatments.