Last reviewed 2026-04-23 · How we verify

Intranasal capsaicin

The University of Texas Health Science Center, Houston · Phase 3 active Small molecule

Intranasal capsaicin is a TRPV1 agonist / Topical analgesic Small molecule drug developed by The University of Texas Health Science Center, Houston. It is currently in Phase 3 development for Cluster headache, Rhinitis / Nasal pain conditions.

Intranasal capsaicin activates TRPV1 nociceptors in the nasal mucosa to desensitize pain-sensing nerve fibers and reduce neurogenic inflammation.

Intranasal capsaicin activates TRPV1 nociceptors in the nasal mucosa to desensitize pain-sensing nerve fibers and reduce neurogenic inflammation. Used for Cluster headache, Rhinitis / Nasal pain conditions.

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Intranasal capsaicin
Sponsor	The University of Texas Health Science Center, Houston
Drug class	TRPV1 agonist / Topical analgesic
Target	TRPV1 (Transient Receptor Potential Vanilloid 1)
Modality	Small molecule
Therapeutic area	Neurology / Pain Management
Phase	Phase 3

Mechanism of action

Capsaicin is a natural compound that binds to and activates the transient receptor potential vanilloid 1 (TRPV1) channel on sensory nerve endings. Upon initial activation, it causes release of neuropeptides like substance P and CGRP, but with repeated or sustained exposure, it leads to desensitization of these nociceptors. This desensitization reduces pain signaling and neurogenic inflammatory responses in the nasal cavity.

Approved indications

Cluster headache
Rhinitis / Nasal pain conditions

Common side effects

Nasal irritation / burning
Rhinorrhea
Sneezing
Transient headache exacerbation

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Intranasal capsaicin CI brief — competitive landscape report
Intranasal capsaicin updates RSS · CI watch RSS
The University of Texas Health Science Center, Houston portfolio CI

Frequently asked questions about Intranasal capsaicin

What is Intranasal capsaicin?

Intranasal capsaicin is a TRPV1 agonist / Topical analgesic drug developed by The University of Texas Health Science Center, Houston, indicated for Cluster headache, Rhinitis / Nasal pain conditions.

How does Intranasal capsaicin work?

Intranasal capsaicin activates TRPV1 nociceptors in the nasal mucosa to desensitize pain-sensing nerve fibers and reduce neurogenic inflammation.

What is Intranasal capsaicin used for?

Intranasal capsaicin is indicated for Cluster headache, Rhinitis / Nasal pain conditions.

Who makes Intranasal capsaicin?

Intranasal capsaicin is developed by The University of Texas Health Science Center, Houston (see full The University of Texas Health Science Center, Houston pipeline at /company/the-university-of-texas-health-science-center-houston).

What drug class is Intranasal capsaicin in?

Intranasal capsaicin belongs to the TRPV1 agonist / Topical analgesic class. See all TRPV1 agonist / Topical analgesic drugs at /class/trpv1-agonist-topical-analgesic.

What development phase is Intranasal capsaicin in?

Intranasal capsaicin is in Phase 3.

What are the side effects of Intranasal capsaicin?

Common side effects of Intranasal capsaicin include Nasal irritation / burning, Rhinorrhea, Sneezing, Transient headache exacerbation.

What does Intranasal capsaicin target?

Intranasal capsaicin targets TRPV1 (Transient Receptor Potential Vanilloid 1) and is a TRPV1 agonist / Topical analgesic.

Drug class: All TRPV1 agonist / Topical analgesic drugs
Target: All drugs targeting TRPV1 (Transient Receptor Potential Vanilloid 1)
Manufacturer: The University of Texas Health Science Center, Houston — full pipeline
Therapeutic area: All drugs in Neurology / Pain Management
Indication: Drugs for Cluster headache
Indication: Drugs for Rhinitis / Nasal pain conditions

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing