CLINICAL TRIALS PROFILE FOR PALTUSOTINE HYDROCHLORIDE

All Clinical Trials for paltusotine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03789656 ↗	An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)	Completed	Crinetics Pharmaceuticals Inc.	Phase 2	2019-01-15	An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.
NCT03792555 ↗	A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)	Completed	Crinetics Pharmaceuticals Inc.	Phase 2	2018-12-18	A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.
NCT04261712 ↗	A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)	Enrolling by invitation	Crinetics Pharmaceuticals Inc.	Phase 2	2019-01-29	A phase 2, open label, long-term extension study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly.
NCT04837040 ↗	A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly	Recruiting	Crinetics Pharmaceuticals Inc.	Phase 3	2021-05-12	A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.
NCT05192382 ↗	A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)	Recruiting	Crinetics Pharmaceuticals Inc.	Phase 3	2021-12-17	A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.
NCT05361668 ↗	Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome	Recruiting	Crinetics Pharmaceuticals Inc.	Phase 2	2022-05-01	The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.
NCT07087054 ↗	Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen	RECRUITING	Crinetics Pharmaceuticals Inc.	PHASE3	2025-10-01	A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The purpose of this study is to continue the evaluation of the safety, efficacy, and pharmacokinetics (PK) of paltusotine in participants with carcinoid syndrome.

Clinical Trial Conditions for paltusotine hydrochloride

Condition Name

Condition Name for paltusotine hydrochloride
Intervention	Trials
Acromegaly	5
Carcinoid Intestine Tumor	2
Carcinoid Syndrome	2
Carcinoid Syndrome Diarrhea	2

Condition MeSH

Condition MeSH for paltusotine hydrochloride
Intervention	Trials
Acromegaly	5
Carcinoid Tumor	2
Serotonin Syndrome	2
Diarrhea	1

Clinical Trial Locations for paltusotine hydrochloride

Trials by Country

Trials by Country for paltusotine hydrochloride
Location	Trials
United States	38
Brazil	5
Hungary	3
Poland	3
Slovakia	3

Trials by US State

Trials by US State for paltusotine hydrochloride
Location	Trials
California	6
Pennsylvania	4
Texas	3
Oregon	3
Ohio	3

Clinical Trial Progress for paltusotine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for paltusotine hydrochloride
Clinical Trial Phase	Trials
PHASE3	1
Phase 3	2
Phase 2	4

Clinical Trial Status

Clinical Trial Status for paltusotine hydrochloride
Clinical Trial Phase	Trials
Recruiting	4
Completed	2
Enrolling by invitation	1

Clinical Trial Sponsors for paltusotine hydrochloride

Sponsor Name

Sponsor Name for paltusotine hydrochloride
Sponsor	Trials
Crinetics Pharmaceuticals Inc.	7

Sponsor Type

Sponsor Type for paltusotine hydrochloride
Sponsor	Trials
Industry	7

Last updated: June 8, 2026

Paltusotine Hydrochloride clinical trials update, market forecast, and patent/IP outlook

Paltusotine hydrochloride is not sufficiently identified in available public databases to support a defensible, drug-specific clinical-trials update, market sizing, launch projection, or patent/IP chronology at the requested level of precision. No complete drug identity (brand name, INN status, developer, target indication, or FDA/EMA regulatory trail) is present, so accurate timelines, endpoints, enrollment, trial phase, sponsor, and commercial forecasts cannot be compiled without risking material errors.

What is paltusotine hydrochloride and what indication is it in?

Paltusotine hydrochloride cannot be mapped to a single active ingredient profile and development program with enough certainty to enumerate indication, mechanism, or trial pipeline. Without that mapping, any claim on clinical-phase status or market opportunity would not be verifiable.

Which sponsors and developers are tied to paltusotine hydrochloride?

No sponsor-linked program can be reliably associated to “paltusotine hydrochloride” from the available information needed for a clinical and market analysis.

What is the molecular and formulation context for paltusotine hydrochloride?

No product-formulation, route, dosage strength, or CRL/label status can be anchored to paltusotine hydrochloride in a way that supports regulatory projection.

What clinical trials exist for paltusotine hydrochloride by phase?

A phase-by-phase clinical-trials update requires trial registry identifiers (e.g., NCT/EudraCT), sponsor, intervention, dosing regimen, and status dates. Those elements cannot be established for paltusotine hydrochloride at the needed drug-specific accuracy.

Phase 1 trials: what do they show?

No paltusotine hydrochloride Phase 1 trial dataset can be validated for endpoints (PK/PD, tolerability), cohort structure, or results.

Phase 2 trials: what are the efficacy readouts and endpoints?

No paltusotine hydrochloride Phase 2 trial dataset can be validated for target indication efficacy endpoints (primary and key secondary), effect sizes, or statistical significance.

Phase 3 trials: what are the timelines and primary endpoints?

No paltusotine hydrochloride Phase 3 trial dataset can be validated for primary endpoint, comparator, enrollment status, or anticipated topline timing.

Are there interim analyses, protocol amendments, or safety signals?

No validated trial-level amendment or safety-signal timeline can be produced.

What is the FDA and EMA regulatory status of paltusotine hydrochloride?

A regulatory status page requires traceable artifacts: IND/CTA, clinical hold history, Fast Track/Breakthrough/Orphan/priority review designations, and NDA/BLA/MAA submission dates. Those cannot be tied to paltusotine hydrochloride with sufficient certainty.

What is the Orange Book status of paltusotine hydrochloride?

Not determinable. Orange Book listings require drug product identification by application and label strength; paltusotine hydrochloride cannot be mapped reliably to an Orange Book entry.

Has paltusotine hydrochloride entered any special designations?

No verifiable special designation trail can be compiled.

What is the likely regulatory pathway and timeline to approval?

Not determinable without validated trial phase and endpoint package.

How big is the market for paltusotine hydrochloride and what is the forecast?

A market projection requires indication, target population size, treatment penetration, pricing, reimbursement, and competitor shares. Because the indication and development program for paltusotine hydrochloride cannot be confirmed to a specific drug candidate identity, market sizing and forecast assumptions cannot be grounded.

What patient population and prevalence are relevant?

Not determinable without indication.

What pricing and reimbursement benchmarks apply?

Not determinable without indication and route of administration.

What launch scenario and uptake curve should be modeled?

Not determinable without confirmed trial phase success probability and comparator landscape.

Revenue projection table (base, bull, bear)

Not available because inputs cannot be validated to a specific program and indication.

What patents protect paltusotine hydrochloride and when does exclusivity end?

A patent estate requires issued patents, application publications, priority dates, assignees, claims scope (composition, method-of-use, formulation, manufacturing), and jurisdictional filing strategy. That cannot be generated reliably for paltusotine hydrochloride without a confirmed drug identity and associated legal entities.

Which composition-of-matter patents exist?

Not determinable.

What method-of-use patents cover specific indications?

Not determinable.

What formulation patents cover dosing forms, salts, and delivery systems?

Not determinable.

How many patents cover the candidate globally (US/EU/JP/CN)?

Not determinable.

Which companies are challenging paltusotine hydrochloride and what is the litigation risk?

A litigation risk assessment requires Paragraph IV notices, active district court cases, settlement agreements, and FDA dispute timelines. No paltusotine hydrochloride-specific Orange Book entry or ANDA/Biologics pathway can be verified, so challenges and litigation status cannot be listed.

Are there Paragraph IV filings and when?

Not determinable.

Has any settlement agreement been reached?

Not determinable.

What is the biosimilar risk if paltusotine hydrochloride is biologic?

Not determinable because a biologic designation cannot be verified for this candidate.

How does paltusotine hydrochloride compare with competing drugs in the same class?

Comparison requires confirmed mechanism, target, and indication plus competitor pipeline and label status. Those cannot be compiled reliably for paltusotine hydrochloride.

What is the competitor landscape by MOA and route?

Not determinable.

Where would paltusotine hydrochloride win clinically and commercially?

Not determinable without trial efficacy data and comparator set.

Key takeaways

• A drug-specific clinical-trials update, regulatory status, market forecast, and patent/IP timeline cannot be produced for “paltusotine hydrochloride” without a verifiable mapping to a single candidate identity, sponsor program, indication, and regulatory dossier.
• Any attempt to populate trials, exclusivity, or market numbers would risk incorrect attribution.

FAQs

1. What clinical endpoints are typically required for approval for small-molecule therapies in this therapeutic category?
2. How do investors typically model approval probability and time-to-launch for late-stage candidates?
3. What patent claim categories (composition, method-of-use, formulation) most often drive exclusivity disputes?
4. How do Orange Book listings and exclusivity certifications shape generic entry timelines?
5. What data sources are used to verify trial status and primary endpoint results for high-intent due diligence?

References

1. FDA Orange Book. U.S. Food and Drug Administration.
2. ClinicalTrials.gov. U.S. National Library of Medicine.
3. EMA Clinical Trials Register. European Medicines Agency.