CLINICAL TRIALS PROFILE FOR FENTANYL CITRATE

All Clinical Trials for fentanyl citrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003000 ↗	Morphine for the Treatment of Pain in Patients With Breast Cancer	Completed	Roswell Park Cancer Institute		1992-05-01	RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine in different ways may offer more pain relief. PURPOSE: This randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder in treating pain in patients who have breast cancer and who are undergoing axillary lymph node dissection.
NCT00105287 ↗	Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients	Completed	Cephalon	Phase 3	2005-01-01	The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.
NCT00105937 ↗	OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients	Completed	Cephalon	Phase 3	2004-04-01	The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.
NCT00125801 ↗	The Pain Pen for Breakthrough Cancer Pain	Terminated	Erasmus Medical Center	Phase 3	2005-08-01	The purpose of this study is to see whether injection of hydromorphone through a subcutaneous injection device is more effective in treating breakthrough cancer pain than oral morphine.
NCT00209534 ↗	A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy	Completed	Bio Analytical Research Corporation	Phase 2	2003-01-01	This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing adequate sedation in patients undergoing colonoscopy. Prior to the procedure, patients received fentanyl citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation. Throughout the procedure, study personnel assessed the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator were asked to complete satisfaction surveys.
NCT00209534 ↗	A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy	Completed	HHI Clinical Research (Biostatistics)	Phase 2	2003-01-01	This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing adequate sedation in patients undergoing colonoscopy. Prior to the procedure, patients received fentanyl citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation. Throughout the procedure, study personnel assessed the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator were asked to complete satisfaction surveys.
NCT00209534 ↗	A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Elective Colonoscopy	Completed	MDS Pharma Services	Phase 2	2003-01-01	This study was designed to assess the safety and efficacy of AQUAVAN® Injection in providing adequate sedation in patients undergoing colonoscopy. Prior to the procedure, patients received fentanyl citrate for pain management followed five minutes later by AQUAVAN® Injection for sedation. Throughout the procedure, study personnel assessed the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator were asked to complete satisfaction surveys.

Clinical Trial Conditions for fentanyl citrate

Condition Name

Condition Name for fentanyl citrate
Intervention	Trials
Pain	23
Cancer	9
Postoperative Pain	5
Pain, Postoperative	5

Condition MeSH

Condition MeSH for fentanyl citrate
Intervention	Trials
Breakthrough Pain	16
Pain, Postoperative	11
Cancer Pain	6
Dyspnea	5

Clinical Trial Locations for fentanyl citrate

Trials by Country

Trials by Country for fentanyl citrate
Location	Trials
United States	200
Canada	9
Egypt	8
India	6
Korea, Republic of	5

Trials by US State

Trials by US State for fentanyl citrate
Location	Trials
New York	14
California	12
Texas	11
North Carolina	10
Florida	10

Clinical Trial Progress for fentanyl citrate

Clinical Trial Phase

Clinical Trial Phase for fentanyl citrate
Clinical Trial Phase	Trials
PHASE4	1
PHASE1	1
Phase 4	25

Clinical Trial Status

Clinical Trial Status for fentanyl citrate
Clinical Trial Phase	Trials
Completed	60
Unknown status	12
RECRUITING	12

Clinical Trial Sponsors for fentanyl citrate

Sponsor Name

Sponsor Name for fentanyl citrate
Sponsor	Trials
Cephalon	11
Eisai Inc.	8
PPD	5

Sponsor Type

Sponsor Type for fentanyl citrate
Sponsor	Trials
Other	90
Industry	54
NIH	3

Last updated: April 28, 2026

Fentanyl Citrate: Clinical-Program Update, Market Positioning, and 2026-2030 Projection

What does the current fentanyl-citrate clinical landscape look like?

“Fentanyl citrate” is the citrate salt form of fentanyl used in multiple pain-management settings (perioperative anesthesia, acute pain, cancer pain, and breakthrough pain). Clinical development is active across:

• Transdermal fentanyl delivery programs (patches) in chronic pain.
• Oral transmucosal fentanyl programs (rapid onset) for breakthrough cancer pain.
• Parenteral fentanyl (often under citrate salt naming in certain geographies and formulations) for perioperative use.

However, a clinical-trials “update” that is specific to fentanyl citrate as the exact drug substance (salt form) requires source-level linkage to trials labeled “fentanyl citrate” in registries. Without a registry-anchored extraction, any trial list, phase distribution, start/completion dates, or recruitment status would be structurally incomplete and not decision-grade.

What is the market reality for fentanyl citrate (and why salt-level specificity matters)?

From a commercial standpoint, fentanyl’s market is driven by formulation class and route, not by the citrate salt alone. Salt form is typically secondary to:

• Route (transdermal, oral transmucosal, injectable).
• Indication (chronic pain vs breakthrough cancer pain vs perioperative anesthesia).
• Regulatory approval scope for specific formulations and label language.

For investors and R&D teams, the practical market view is:

• Fentanyl is a core opioid analgesic with broad clinical adoption.
• Growth concentrates in branded and controlled-release delivery systems where patent estates, REMS-like restrictions, and payer contracting shape share.
• Regulatory scrutiny and diversion controls affect uptake patterns and market accessibility.

How do manufacturers typically segment fentanyl commercialization by product class?

Market segmentation that aligns with buying patterns and prescribing behavior is usually:

1. Transdermal fentanyl (longer-duration chronic pain management).
2. Oral transmucosal fentanyl (rapid onset for breakthrough pain).
3. Injectables (perioperative and acute pain).

Salt naming (citrate) often appears in supply-chain and dossier detail, but launch and share are tracked at formulation level in payer and prescriber channels.

What does the demand-and-supply equation look like through 2030?

Fentanyl demand is shaped by four forces:

1) Clinical demand from persistent pain indications

• Chronic pain treatment sustains the transdermal base.
• Breakthrough cancer pain drives rapid-onset demand when prescribers follow labeling.

2) Regulatory and risk controls

• Opioid safety programs, controlled-substance monitoring, and prescribing restrictions influence access and dosing behavior.
• Risk management requirements affect channel conversion (especially in institutional purchasing).

3) Competitive substitution

• Within fentanyl, different formulations substitute for each other based on onset and duration needs.
• Across opioid classes, substitution depends on payer formularies and adverse-event management.

4) Supply reliability and procurement

• Controlled substance procurement patterns and manufacturing continuity affect hospital and distributor availability.

What is the market projection for fentanyl citrate to 2030?

A decision-grade projection requires published market sizing with fentanyl-specific definitions. Without a cited baseline (e.g., “fentanyl market” with year, geography, and formulation class definition), providing a numeric forecast would not meet hard-data standards.

Therefore, this report does not provide unanchored CAGR or dollar figures for “fentanyl citrate” as a distinct salt-form market. Any numeric projection at salt level would be non-actionable.

What can be stated with decision relevance is directionality and drivers:

• Growth is tied to formulation modernization and label expansion rather than to salt form.
• Share gains come from reliable supply plus payer-validated dosing regimens in transdermal and rapid-onset segments.
• Risk-control environments cap rapid share swings but do not eliminate long-run opioid analgesic demand.

Where are the highest-value R&D and patent-activity targets inside fentanyl programs?

Patent and R&D value tracks to:

• Delivery systems (membranes, formulations, protected-release matrices).
• Onset-time engineering (especially oral transmucosal systems).
• Device-associated IP (if applicable).
• Label and regimen optimization (where legally supported and supported by clinical data).

Salt form alone rarely generates durable differentiation once therapeutically equivalent forms exist and formulary access is established.

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Key Takeaways

• Fentanyl commercial momentum is driven by route and formulation class, not citrate salt identity.
• A precise “clinical trials update” for fentanyl citrate as named salt-form requires registry-anchored extraction; without that linkage, any trial list would be incomplete.
• Market growth direction through 2030 is supported by persistent pain indications, constrained by controlled-substance risk controls, and captured via transdermal and rapid-onset product classes.
• For R&D and investment screening, priority IP targets are delivery systems and onset-time engineering, not salt form.

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FAQs

1) Is fentanyl citrate clinically different from other fentanyl salts?

Salt selection generally affects formulation properties and manufacturability more than core opioid pharmacology. Clinical outcomes are primarily driven by route and release profile.

2) What product classes account for most fentanyl commercial value?

Transdermal fentanyl and oral transmucosal fentanyl account for the majority of prescription-driven value, with injectables anchoring perioperative demand.

3) Does “fentanyl citrate” have a distinct market tracked independently?

Markets are typically tracked at fentanyl API and formulation class levels; “citrate” is usually not the primary commercial unit for payer and prescribing decisions.

4) What most impacts future fentanyl share: new clinical evidence or formulation improvements?

Formulation improvements and delivery-system differentiation typically determine market uptake faster than incremental clinical evidence once standard-of-care regimens exist.

5) Why do regulatory constraints matter for long-term projections?

Controlled-substance controls affect prescribing access, dispensing logistics, and risk-managed rollout, shaping adoption curves even when clinical demand exists.

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References

[1] FDA. “Drug Safety and Availability.” U.S. Food and Drug Administration.
[2] EMA. “Opioids.” European Medicines Agency.
[3] WHO. “Guidelines for the Management of Long-term Opioid Therapy.” World Health Organization.
[4] ClinicalTrials.gov. “Fentanyl.” U.S. National Library of Medicine.
[5] DrugBank. “Fentanyl.” DrugBank Online.