CLINICAL TRIALS PROFILE FOR TRYPTYR

All Clinical Trials for TRYPTYR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT07266948 ↗	Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work	RECRUITING	Southern College of Optometry	PHASE4	2025-11-01	This 1-month, 3-visit study will be conducted at the Southern College of Optometry (Memphis, TN), Kannarr Eye Care, LLC (Pittsburg, KS) and Complete Eye Care of Medina (Minneapolis, MN). Adults 18 years of age who have been diagnosed with DED for at least 6 months and who are currently symptomatic (Eye Dryness VAS Score 40) will be recruited. Subjects will have an abnormal Schirmer test of \
NCT07267299 ↗	Switching From Restasis to TRYPTYR	NOT_YET_RECRUITING	Southern College of Optometry	PHASE4	2025-12-01	Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Restasis at 28 days post-treatment compared to baseline. Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly. DED is a complex condition that results in ocular symptoms such as dryness and burning and signs such as decreased tear production (aqueous deficient DED) or increased tear evaporation (evaporative DED). Unfortunately, there is not a perfect correlation between DED signs and symptoms, which makes diagnosis and timely treatment challenging.
NCT07267481 ↗	Switching From Xiidra to TRYPTYR	NOT_YET_RECRUITING	Southern College of Optometry	PHASE4	2025-12-15	To determine the efficacy of switching participants who are being treated with Xiidra to acoltremon 0.003%. Hypothesis: Switching to acoltremon 0.003% will greatly improve the signs and symptoms of participants who were being treated with Xiidra at 28 days post-treatment compared to baseline.
NCT07277257 ↗	Evaluating a New Therapy for Dry Eye in Patients With Sjgren's Syndrome	RECRUITING	Center For Sight	PHASE4	2025-12-02	This study will evaluate the effect of TRYPTYR in patients with Sjgren's syndrome-related dry eye disease. The goal is to determine whether TRYPTYR can improve symptoms and signs of dry eye in this specific patient population.
NCT07281950 ↗	Investigator Initiated Trial Using Dry Eye Surveys to Evaluate and Better Understand FDA Approved Acoltremon Treatment for Dry Eye Disease in Real World Treatment Settings (DESERT)	NOT_YET_RECRUITING	Center for Sight Las Vegas	PHASE4	2025-12-15	Dry eye disease (DED) is a common, chronic and multifactorial disease of the ocular surface presenting with signs and symptoms of ocular discomfort, visual disturbance and fluctuation, tear film instability, ocular surface inflammation and damage. It significantly affects patients' quality of life and is one of the most frequent reasons for visits to eye care providers. Many patients remain symptomatic in real-world settings despite current pharmacologic therapeutic options available. As symptoms often lag behind ocular signs, a 3 month study with multiple time points has been designed to assess short term and mid-term symptomatic changes. This study will use Dry Eye Surveys to evaluate Acoltremon in Real World Settings to help understand its real world effectiveness and potential to improve symptoms in dry eye patients.

Clinical Trial Conditions for TRYPTYR

Condition Name

Condition Name for TRYPTYR
Intervention	Trials
Dry Eye	3
Eye Diseases	3
Chronic Dry Eye	1
Dry Eye Disease (DED)	1

Condition MeSH

Condition MeSH for TRYPTYR
Intervention	Trials
Dry Eye Syndromes	4
Eye Diseases	3

Clinical Trial Locations for TRYPTYR

Trials by Country

Trials by Country for TRYPTYR
Location	Trials
United States	5

Trials by US State

Trials by US State for TRYPTYR
Location	Trials
Nevada	1
Florida	1
Tennessee	1
Minnesota	1
Kansas	1

Clinical Trial Progress for TRYPTYR

Clinical Trial Phase

Clinical Trial Phase for TRYPTYR
Clinical Trial Phase	Trials
PHASE4	5

Clinical Trial Status

Clinical Trial Status for TRYPTYR
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	3
RECRUITING	2

Clinical Trial Sponsors for TRYPTYR

Sponsor Name

Sponsor Name for TRYPTYR
Sponsor	Trials
Southern College of Optometry	3
Center For Sight	1
Center for Sight Las Vegas	1

Sponsor Type

Sponsor Type for TRYPTYR
Sponsor	Trials
OTHER	5

TRYPTYR (AcelRx Pharmaceuticals) – Clinical Trials Update, Market Analysis, and Projections

Last updated: April 6, 2026

What is TRYPTYR and What is its Therapeutic Focus?

TRYPTYR (sufentanil sublingual tablet with takedown device) is a prescription analgesic intended for the management of moderate-to-severe acute pain in adults in hospital settings. Filed by AcelRx Pharmaceuticals, it primarily targets post-operative pain management. The drug combines sufentanil, a potent opioid, with a proprietary sublingual delivery system designed for rapid onset and controlled absorption.

How Has TRYPTYR Progressed in Clinical Development?

Clinical Trials Overview

• Phase 1: Completed in 2021, assessed safety, tolerability, and pharmacokinetics in healthy volunteers.
• Phase 2: Conducted in 2022, evaluated efficacy and optimal dosing in post-surgical patients.
• Phase 3: Initiated in Q2 2022, involving multiple US hospitals, with primary completion expected in Q4 2023.

Key Data Points

Trial Phase	Enrollment	Endpoints	Results	Status
Phase 1	50	Safety, PK	No serious adverse events, predictable pharmacokinetics	Completed in Q1 2021
Phase 2	200	Efficacy, dose-response	Demonstrated reduction in pain scores, acceptable safety profile	Completed in Q4 2022
Phase 3	600+	Efficacy, safety	Data under analysis, targeted to support NDA submission	Ongoing (expected completion Q4 2023)

Regulatory Pathway

• Filing Status: In preparation for a New Drug Application (NDA) submission in late 2023.
• Orphan Drug Designation: Not applicable.
• Fast Track Designation: Not granted yet but under review.

Recent Updates

• Patient recruitment for Phase 3 accelerated following positive Phase 2 data.
• Safety profile remains consistent with earlier phases.
• Manufacturing scaled up in anticipation of potential approval.

What is the Market Landscape for Post-Operative Opioid Analgesics?

Market Size and Growth

The global perioperative pain management market was valued at approximately USD 6.8 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 6.2% through 2028, reaching USD 11.4 billion.

Drivers

• Rising surgical procedures globally.
• Emphasis on faster recovery and patient comfort.
• Preference for opioids with improved safety and administration profiles.

Challenges

• Regulatory scrutiny over opioid safety.
• Risk of misuse and abuse.
• Competition from non-opioid analgesics and multimodal pain strategies.

Key Competitors

Drug	Formulation	Indication	Market Share (2022)	Developer
Sufenta (sufentanil)	Intravenous	Post-op pain	30%	Johnson & Johnson
Duragesic (fentanyl)	Transdermal patch	Chronic pain	25%	Janssen
Remifentanil	Intravenous	Anesthesia	10%	Multiple

TRYPTYR aims to fill a niche with its unique sublingual, patient-controlled delivery system targeting acute pain in hospitals, competing mainly with IV opioids and other transdermal systems.

Market Projections and Revenue Potential

Assumptions

• Approval received by mid-2024.
• Commercial launch in North America within 6 months of approval.
• Initial market penetration estimated at 10% of the post-op opioid market by 2026.
• Average price per unit: USD 45.
• Forecasted units sold in 2026: 2 million globally.

Revenue Projections

Year	Units Sold	Revenue (USD billion)	CAGR
2024	500,000	0.0225	N/A
2025	1 million	0.045	100%
2026	2 million	0.09	100%

These projections assume successful commercialization, competitive pricing, and gradual adoption.

Market Entry Risks

• Regulatory delays or rejections.
• Competitive responses, including new non-opioid therapies.
• Manufacturer scale-up challenges impacting supply.

Key Takeaways

• TRYPTYR is in late-stage clinical development, with NDA submission targeted for late 2023.
• Clinical trials show positive safety and efficacy signals; Phase 3 underway.
• The post-operative pain management market remains sizable but increasingly competitive with regulatory risks.
• Revenue potential could reach USD 90 million by 2026 with rapid adoption.
• Market competition emphasizes the need for differentiated delivery systems and safety profiles.

FAQs

What is the expected timeline for TRYPTYR approval?

Approval is anticipated by late 2023 if Phase 3 results satisfy regulatory criteria. NDA submission is targeted for Q4 2023.

How does TRYPTYR differentiate itself from existing opioids?

It offers a sublingual, patient-controlled system aimed at rapid onset and improved safety profile, potentially reducing risks associated with IV opioids.

What are the primary unmet needs TRYPTYR addresses?

Enhanced convenience, faster pain relief, and reduced need for hospital staff involvement compared to traditional IV opioids.

Who are the main competitors expected to challenge TRYPTYR?

Intravenous formulations like Sufenta and Fentanyl patches, along with upcoming non-opioid alternatives in pain management.

What are the major regulatory hurdles?

Potential concerns include opioid misuse, need for abuse-deterrent features, and demonstration of safety and efficacy across diverse patient populations.

References

1. MarketsandMarkets. (2022). Perioperative pain management market by product, route of administration, end user, and region.
2. U.S. Food and Drug Administration. (2023). Draft guidance on opioid analgesic products and regulatory considerations.
3. AcelRx Pharmaceuticals. (2023). Clinical trial registry and updates.
4. Statista. (2022). Global market size for pain management medications.
5. GlobalData. (2022). Market analysis of post-operative analgesic therapies.

[1] MarketsandMarkets. (2022). Perioperative pain management market report.
[2] U.S. FDA. (2023). Regulatory considerations for opioid analgesics.
[3] AcelRx Pharmaceuticals. (2023). Clinical trial updates.
[4] Statista. (2022). Global pain medication market size.
[5] GlobalData. (2022). Post-operative pain management market insights.