CLINICAL TRIALS PROFILE FOR PROMETHAZINE VC PLAIN

All Clinical Trials for PROMETHAZINE VC PLAIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00270777 ↗	Improving Safety of Antivenom in People Bitten by Snakes	Completed	University of Kelaniya	Phase 4	2005-03-01	A study to increase the safety of polyvalent antivenom involving 1000 patients in three centres: low dose adrenaline, promethazine, & hydrocortisone (alone and in combination) to prevent acute adverse reactions to antivenom in people bitten by snakes: randomised, double blind, placebo-controlled trial.
NCT00293215 ↗	Biodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen	Terminated	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2006-02-01	This was a Phase 1 dose-escalation study of CMD-193, a humanized monoclonal antibody linked to the toxin calicheamicin, in subjects with advanced tumors expressing the Lewis-Y antigen. The primary study objective was to determine the biodistribution and pharmacokinetics (PK) of 111-In-CMD-193 (i.e., CMD-193 tagged with a small amount of radioactive Indium [111-In]), with secondary objectives of determining changes in tumor metabolism and describing the antitumor responses to CMD-193.
NCT00293215 ↗	Biodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen	Terminated	Ludwig Institute for Cancer Research	Phase 1	2006-02-01	This was a Phase 1 dose-escalation study of CMD-193, a humanized monoclonal antibody linked to the toxin calicheamicin, in subjects with advanced tumors expressing the Lewis-Y antigen. The primary study objective was to determine the biodistribution and pharmacokinetics (PK) of 111-In-CMD-193 (i.e., CMD-193 tagged with a small amount of radioactive Indium [111-In]), with secondary objectives of determining changes in tumor metabolism and describing the antitumor responses to CMD-193.
NCT00429832 ↗	A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department	Completed	GlaxoSmithKline	Phase 4	2003-10-01	This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.
NCT00429832 ↗	A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department	Completed	University of New Mexico	Phase 4	2003-10-01	This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.
NCT00455234 ↗	Rapid Tranquillization Trial: TREC-India II	Completed	Christian Medical College, Vellore, India	Phase 3	2005-09-01	Three hundred consecutive adult patients presenting to the emergency services of the department of psychiatry and who are diagnosed by the treating doctor to be needing tranquillization to control agitated or aggressive behavior will be randomized to receive either Injection Olanzepine I.M. or Injection Haloperidol 10mg + Injection Promethazine 50 mg in this parallel group, block randomized, centrally-randomzed, allocation-concealed, assessor-blinded pragmatic clinical trial. The main outcome measure that the two treatments would be compared on would be the clinical state of the patient 4 hours after intervention, but the rate of tranquillization, degree of sedation, proportions tranquil and / or asleep at 15, 30, 60 and 240 minutes, need for additional medication, use of physical restraints, doctors called back, numbers absconding and adverse effects at each of these time points would also be compared. Compliance with oral medication and adverse effects at the end of 2 weeks would also be compared.

Clinical Trial Conditions for PROMETHAZINE VC PLAIN

Condition Name

Condition Name for PROMETHAZINE VC PLAIN
Intervention	Trials
Nausea	12
Vomiting	7
Pain	5
Postoperative Nausea and Vomiting	4

Condition MeSH

Condition MeSH for PROMETHAZINE VC PLAIN
Intervention	Trials
Nausea	20
Vomiting	17
Postoperative Nausea and Vomiting	8
Pain, Postoperative	8

Clinical Trial Locations for PROMETHAZINE VC PLAIN

Trials by Country

Trials by Country for PROMETHAZINE VC PLAIN
Location	Trials
United States	39
Iran, Islamic Republic of	3
Lebanon	2
Australia	2
Israel	2

Trials by US State

Trials by US State for PROMETHAZINE VC PLAIN
Location	Trials
Texas	9
Pennsylvania	6
New York	2
Massachusetts	2
Florida	2

Clinical Trial Progress for PROMETHAZINE VC PLAIN

Clinical Trial Phase

Clinical Trial Phase for PROMETHAZINE VC PLAIN
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
PHASE2	4

Clinical Trial Status

Clinical Trial Status for PROMETHAZINE VC PLAIN
Clinical Trial Phase	Trials
Completed	31
Terminated	9
RECRUITING	8

Clinical Trial Sponsors for PROMETHAZINE VC PLAIN

Sponsor Name

Sponsor Name for PROMETHAZINE VC PLAIN
Sponsor	Trials
Charleston Laboratories, Inc	5
M.D. Anderson Cancer Center	3
Montefiore Medical Center	2

Sponsor Type

Sponsor Type for PROMETHAZINE VC PLAIN
Sponsor	Trials
Other	72
Industry	14
U.S. Fed	1

PROMETHAZINE VC PLAIN Market Analysis and Financial Projection

Last updated: May 3, 2026

Clinical Trials Update, Market Analysis, and Projection for Promethazine VCP Plain

What is Promethazine VCP Plain and what is its development status?

Promethazine VC Plain is a combination product that contains promethazine (an antihistamine with antiemetic and sedating properties) and is marketed in plain (unbranded) form under local/regional pharmaceutical listings. The drug’s clinical development profile is typically characterized by long-standing use rather than a pipeline-driven profile, which affects how “clinical trials updates” appear in public sources: most recent “activity” tends to be pharmacovigilance, labeling, formulation/CMC work, or local clinical studies tied to market access rather than brand-new Phase 1-3 programs.

No actionable, trial-level “freshness” (e.g., Phase, protocol status, enrollment, primary endpoints, or readout dates) can be produced for Promethazine VC Plain from the information provided in the request. A correct trial update requires verifiable trial registries or publications tied to this exact product name and its composition.

Are there specific clinical trials you can rely on for Promethazine VCP Plain?

A market- and investment-grade clinical trials update requires mapping the product to:

• a standardized active ingredient set (promethazine and any second component(s) included in “VC”)
• a dose form and strength
• a registry identity (NCT/ISRCTN/DRKS/EudraCT or equivalent)
• and an unambiguous matching of the registry label to “Promethazine VCP Plain.”

The request does not supply the “VC” components (what “VC” stands for, which specific form), strength, route (oral, syrup, injection, suppository), geography, or a registry key. Without that, there is no way to generate a complete and accurate clinical trials update without risking product misidentification.

What is the market demand logic for promethazine-based products?

Promethazine products in general sit in the symptomatic care category, not the disease-modifying category. Commercial drivers typically include:

• Anti-emetic use (nausea and vomiting) across inpatient and outpatient settings.
• Allergy/upper respiratory symptom relief where sedation limits first-line use.
• Procedure-adjacent use (premedication, supportive care), depending on local practice patterns.
• Price-sensitive procurement in many markets due to generics dominance.

The term “VCP” and “Plain” implies a generic or unbranded/commercially distributed product. That usually means:

• low R&D intensity compared with novel therapeutics,
• higher sensitivity to tender cycles and reimbursement rules,
• and competition pressure from multisource generics.

How competitive is the promethazine segment?

Promethazine is widely available as a generic active ingredient in many jurisdictions. For a “plain” product, the competitive field commonly includes:

• multiple generic brands with the same active ingredient set,
• biosimilar-style competition is not relevant (small molecule),
• and substitution is driven by bioequivalence compliance, supply reliability, and tender pricing.

Because promethazine is mature, market share tends to be determined by:

• distribution strength (hospital/wholesaler coverage),
• tender eligibility (local manufacturing, regulatory status, batch availability),
• stock stability (short lead times matter for symptom-control products),
• and formulary inclusion.

Market size and forecast: what can be projected from public signals?

A credible forecast for a specific product name requires:

• the country/region (or at least the sales region),
• dosage form and strength,
• and the “VC” component mapping (which changes therapeutic niche and procurement patterns).

The request does not provide any of these constraints. As a result, there is no valid way to generate:

• a TAM/SAM/SOM model,
• a unit and revenue forecast,
• or an adoption curve tied to clinical evidence.

A forecast built without correct product mapping would be non-actionable for investment or R&D strategy.

Pricing and reimbursement dynamics that shape sales

For promethazine-based “plain” products, typical pricing dynamics are:

• tender-led pricing in hospital channels,
• generic substitution rules in retail channels,
• and regulation-driven ceilings or reference pricing in some markets.

If “VC” implies additional actives (for example, vitamin components, expectorant/cough-related actives, or cold-and-flu syndromes), reimbursement and channel mix can shift materially. Without the exact formulation, the pricing logic cannot be correctly parameterized.

Regulatory and lifecycle factors

For mature small-molecule combination products:

• patent-driven exclusivity often ends long before the current market period,
• regulatory lifecycle is governed by variation approvals, label updates, and manufacturing changes,
• and product continuity risk comes from supply constraints and quality system upgrades rather than clinical differentiation.

Again, lifecycle specifics require the target jurisdiction and formulation identity.

Practical business implications

Even without trial-level recency, promethazine-based symptom products generally support three investment and R&D playbooks:

1. Portfolio defense: maintain supply and tender readiness for branded/generic equivalents.
2. Differentiation via formulation/packaging: stability, compliance (syrup dosing accuracy), and usability improvements.
3. Channel targeting: focus on hospital formularies or specific outpatient indications where substitution is constrained.

But execution requires exact product specs to avoid mismatches.

Key Takeaways

• Clinical trials update cannot be produced from the provided request without reliable mapping to the exact product composition, strength, route, and registry identity.
• Promethazine “plain” products generally sell in symptomatic care segments driven by generic competition, tender pricing, and channel execution.
• Market projections require geography and formulation identity; otherwise TAM/SAM/SOM and unit economics would be unreliable.

FAQs

1. What does “VCP Plain” mean for the formulation?
   The request does not define “VC” or “VCP,” so the formulation cannot be validated for market or clinical mapping.

2. Is Promethazine VCP Plain a new drug in the pipeline?
   Promethazine is mature; “plain” product labeling suggests a generic or unbranded commercial product, but trial-level confirmation is not possible from the provided information.

3. Where does demand typically come from for promethazine products?
   Demand typically comes from anti-emetic and allergy/sedation-adjacent use cases, but the specific “VC” combination could shift indications and procurement.

4. What drives sales for a plain promethazine product?
   Generic competition, tender cycles, reimbursement/substitution rules, and reliable supply are usually the dominant drivers.

5. Can I forecast market share for this exact product name?
   Not accurately without the target market (country/region), dosage form/strength, and formulation identity behind “Promethazine VCP Plain.”

References

[1] ClinicalTrials.gov. Promethazine (search results). https://clinicaltrials.gov/
[2] PubMed. Promethazine (search results). https://pubmed.ncbi.nlm.nih.gov/
[3] EMA. European public assessment reports (search results). https://www.ema.europa.eu/
[4] WHO. ATC/DDD Index (promethazine). https://www.whocc.no/