CLINICAL TRIALS PROFILE FOR PENICILLIN-VK

505(b)(2) Clinical Trials for PENICILLIN-VK

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Indication	NCT05069974 ↗	Alternative Antibiotics for Syphilis	Recruiting	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 3	2021-10-01	The Trep-AB clinical trial will test the efficacy of an investigational neuropenetrative drug, Linezolid (LZD), compared to standard treatment, Benzathine penicillin G (BPG), for early syphilis in humans. The overarching idea of the work proposed herein is to investigate the use of LZD to treat syphilis, conducting a randomized controlled clinical trial to evaluate this new indication of a known antibacterial agent. It is estimated to include 360 participants.

All Clinical Trials for PENICILLIN-VK

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000585 ↗	Penicillin Prophylaxis in Sickle Cell Disease (PROPS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1983-08-01	To determine whether the regular daily administration of oral penicillin would reduce the incidence of documented infection due to Streptococcus pneumoniae in children with sickle cell anemia.
NCT00000648 ↗	A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals	Completed	Hoffmann-La Roche	N/A	1969-12-31	To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.
NCT00000648 ↗	A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.
NCT00001359 ↗	Preventive Measures for Childhood-Onset Obsessive-Compulsive Disorder and Tic Disorders (PANDAS Subgroup)	Completed	National Institute of Mental Health (NIMH)	Phase 2	1993-04-01	A subgroup of patients with childhood-onset obsessive-compulsive disorder (OCD) and/or tic disorders has been identified who share a common clinical course characterized by dramatic onset and symptom exacerbations following group A beta-hemolytic streptococcal (GABHS) infections. This subgroup is designated by the acronym PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections). There are five clinical characteristics that define the PANDAS subgroup: presence of OCD and/or tic disorder; prepubertal symptom onset; sudden onset or abrupt exacerbations (relapsing-remitting course); association with neurological abnormalities (presence of adventitious movements or motoric hyperactivity during exacerbations); and temporal association between symptom exacerbations and GABHS infections. In this subgroup, periodic exacerbations appear to be triggered by GABHS infections in a manner similar to that of Sydenham's chorea, the neurological variant of rheumatic fever. Rheumatic fever is a disorder with a presumed post-streptococcal autoimmune etiology. The streptococcal pathogenesis of rheumatic fever is supported by studies that have demonstrated the effectiveness of penicillin prophylaxis in preventing recurrences of this illness. A trial of penicillin prophylaxis in the PANDAS subgroup demonstrated that penicillin was not superior to placebo as prophylaxis against GABHS infections in these children, but this outcome was felt to be secondary to non-compliance with treatment, and there was no decrease in the number of neuropsychiatric symptom exacerbations in this group. In a study comparing azithromycin and penicillin, both drugs were completely effective in preventing streptococcal infections - there were no documented titer elevations during the year-long study period for children taking either penicillin or azithromycin. Comparable reductions in the severity of tics and obsessive-compulsive symptoms were also observed. Thus, penicillin was not performing as an "active placebo" as originally postulated, but rather provided effective prophylaxis against Group A beta-hemolytic streptococcal. Both azithromycin and penicillin appear to be effective in eliminating GABHS infections, and reducing neuropsychiatric symptom severity; thus, between-group differences are negligible. Since increasing the "n" to demonstrate superiority of one prophylactic agent over another would be impractical, we have amended the study design to address two issues: 1. To determine if antibiotics prophylaxis against GABHS infections is superior to placebo in prolonging periods of remission among children in the PANDAS subgroup. 2. To determine if antibiotics prophylaxis against GABHS infections is superior to placebo in improving overall symptom severity for obsessive-compulsive symptoms and tics among children in the PANDAS subgroup. Because penicillin has a narrower therapeutic index and is less expensive than azithromycin, it is the preferable prophylactic agent. Further, penicillin (250 mg orally twice a day) has a long history of providing safe and effective prophylaxis for rheumatic fever and is the first line oral therapy recommended by the American Heart Association. Thus, penicillin has been chosen as the prophylactic antibiotic in the present study. Blister packs are used to increase compliance and to allow for easier documentation of missed doses.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	National Cancer Institute (NCI)	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	M.D. Anderson Cancer Center	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00003824 ↗	S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer	Terminated	National Cancer Institute (NCI)	Phase 3	1999-04-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether ciprofloxacin is more effective than cephalexin in preventing cancer recurrence in patients who are undergoing surgery to treat bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of ciprofloxacin with that of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for bladder cancer.

Clinical Trial Conditions for PENICILLIN-VK

Condition Name

Condition Name for PENICILLIN-VK
Intervention	Trials
Syphilis	12
Penicillin Allergy	11
Helicobacter Pylori Infection	10
Infection	7

Condition MeSH

Condition MeSH for PENICILLIN-VK
Intervention	Trials
Infections	33
Infection	25
Communicable Diseases	24
Syphilis	17

Clinical Trial Locations for PENICILLIN-VK

Trials by Country

Trials by Country for PENICILLIN-VK
Location	Trials
United States	206
China	25
Canada	21
Australia	18
Spain	11

Trials by US State

Trials by US State for PENICILLIN-VK
Location	Trials
California	15
Ohio	12
New York	12
Texas	11
North Carolina	9

Clinical Trial Progress for PENICILLIN-VK

Clinical Trial Phase

Clinical Trial Phase for PENICILLIN-VK
Clinical Trial Phase	Trials
PHASE4	11
PHASE3	6
PHASE2	5

Clinical Trial Status

Clinical Trial Status for PENICILLIN-VK
Clinical Trial Phase	Trials
Completed	89
RECRUITING	37
Not yet recruiting	27

Clinical Trial Sponsors for PENICILLIN-VK

Sponsor Name

Sponsor Name for PENICILLIN-VK
Sponsor	Trials
World Health Organization	7
National Institute of Allergy and Infectious Diseases (NIAID)	6
University of Oxford	5

Sponsor Type

Sponsor Type for PENICILLIN-VK
Sponsor	Trials
Other	379
Industry	26
NIH	11

Last updated: July 27, 2026

Penicillin-VK clinical trials update, market analysis, and commercial projections (2024–2029)

Executive summary: Penicillin V potassium (Penicillin-VK) is an established oral narrow-spectrum beta-lactam with a mature, low-growth commercial profile driven by (1) persistent baseline demand for streptococcal pharyngitis and selected skin/dental indications, (2) periodic formulary and stewardship-driven shifts among generic antibiotics, and (3) limited pipeline replacement due to low patent incentives for “new” oral penicillin-class entries. Clinical activity is largely facility- and formulation-level (bioequivalence, stability, or small comparative studies), not late-stage drug-development. Market value is dominated by generics and price competition in the U.S. and other mature markets, with volume remaining the key variable.

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What clinical trials are being run for Penicillin-VK right now?

Direct answer: Penicillin-VK does not show a clear, regulator-relevant late-stage development program in major registries; active studies are typically bioequivalence, pharmacokinetic (PK), stability, dosing/clinical observation, or manufacturing/formulation comparisons rather than Phase 3 registrational trials.

Where do studies typically cluster (by trial type)?

Most Penicillin-VK trial activity in public sources tends to fall into these categories:

• Bioequivalence and PK: comparisons of oral tablets or suspensions to listed reference products; focus is typically on absorption and exposure metrics.
• Formulation and stability: shelf-life, dissolution, and manufacturing changes, including excipient reformulations that preserve equivalence.
• Clinical observation: small cohorts evaluating real-world outcomes, sometimes in outpatient settings or dental/ENT contexts, without driving an NDA/505(b)(2) pathway.

What does “clinical trials update” mean for a mature generic antibiotic?

For Penicillin-VK, the operational “update” is usually less about new efficacy endpoints and more about:

• Supply continuity (manufacturing scale, API availability, and batch release performance).
• Regulatory equivalence (bioequivalence filings, device/container changes, and suspension reformulations).
• Safety monitoring aligned with ongoing beta-lactam labeling.

Because Penicillin-VK’s active ingredient is off-patent and widely generic, registrational trials are uncommon and commercial differentiation is limited.

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How big is the Penicillin-VK market and what are the key demand drivers?

Direct answer: The market is largely generic volume under intense price competition. Demand tracks outpatient antibiotic prescribing for indications where penicillin remains guideline-concordant and where local access supports narrow-spectrum therapy.

Primary demand drivers

• Guideline-based prescribing for streptococcal pharyngitis (where penicillin-class antibiotics remain standard in many pathways).
• Dental and ENT-related infections managed in primary care, where narrow-spectrum agents are used when risk stratification supports them.
• Stewardship cycles that influence antibiotic selection and duration, affecting per-patient dosing but not eliminating baseline penicillin use.

Constraints shaping the market

• Penicillin allergy and cross-reactivity risk affects patient-level eligibility and therefore volume.
• Substitution by other generics (amoxicillin, cephalexin, clindamycin in selected contexts, and broader-spectrum agents where stewardship allows).
• Infection prevalence and seasonal respiratory patterns create short-term swings.

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What are the market dynamics by geography for Penicillin-VK?

Direct answer: Mature markets show similar dynamics: generics dominate, local payer formularies determine share, and pricing is driven by competition and periodic procurement cycles.

U.S.

• Bulk of commercial activity is generic oral solid and suspension distribution.
• Share is sensitive to:
  • formulary tiering,
  • hospital and clinic purchasing,
  • and wholesale contract pricing.

Europe and other mature markets

• Penicillin-VK is typically a low-to-mid value, high-volume generic where reimbursement rules and national antibiotic guidelines control uptake.

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How are clinicians using Penicillin-VK: indications and dosing focus?

Direct answer: Penicillin-VK is used for narrow-spectrum bacterial infections where streptococcal or susceptible organisms are targeted and where clinicians prefer penicillin-class narrow-spectrum options.

Indications that most influence prescribing volume

• Streptococcal pharyngitis/tonsillitis (classic use case).
• Skin and soft tissue infections from susceptible organisms.
• Dental infections where narrow-spectrum therapy is appropriate.

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What is the FDA regulatory status of Penicillin-VK (Orange Book status)?

Direct answer: Penicillin-VK is marketed as a generic antibiotic; current commercial availability is sustained through ANDA approvals and ongoing compliance rather than brand exclusivity.

What to expect on the Orange Book

• Multiple ANDA holders across:
  • immediate-release tablets,
  • suspensions (where offered),
  • and different strengths/pack sizes.
• Listing can include:
  • relevant patents to formulation, composition, or process only where still active for a specific product line.
  • most active ingredient-related patents are already expired.

(No Orange Book listing table is provided here because the prompt does not include the specific NDC(s) and the request requires hard, itemized listings.)

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When does Penicillin-VK lose exclusivity, and what patent estate still matters?

Direct answer: For Penicillin-VK (active ingredient penicillin V potassium), market exclusivity and patent barriers are historically expired in most jurisdictions; the competitive constraint is largely manufacturing and generic entry economics rather than patent timing.

What “exclusivity” means for a generic penicillin

Even with expired active ingredient patents, practical barriers can still exist via:

• product-specific manufacturing know-how,
• approved formulations and labeling,
• and product-level regulatory maintenance.

(No patent-expiration date table is included because no specific reference product, ANDA, or Orange Book patent numbers were supplied.)

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How many Paragraph IV challenges exist for Penicillin-VK? Which companies are challenging?

Direct answer: Penicillin-VK is not typically a target for frequent Paragraph IV litigation compared with modern small molecules or biologics. Where challenges occur, they tend to be tied to product-specific patent listings on individual ANDA dossiers rather than foundational active ingredient rights.

(No company-by-company litigation map is provided because the required hard data sources were not supplied in the prompt.)

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What patent types would protect Penicillin-VK products if any still exist?

Direct answer: Any remaining intellectual property in the current market is likely to be product-specific rather than active ingredient coverage, typically in the areas of:

• formulation compositions (excipients, release characteristics),
• manufacturing processes,
• packaging or stability claims,
• and method-of-use claims if tied to a specific label subset.

Typical patent categories you may see

• Composition of matter for formulation variants
• Process patents for manufacturing or crystallization
• Stability and shelf-life related claims
• Methods of treatment tied to specific dosing regimens (less common for legacy generics)

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What generic entry risks exist for Penicillin-VK buyers and sponsors?

Direct answer: The primary risks are operational:

• supply constraints,
• quality and regulatory compliance (cGMP),
• and pricing volatility tied to competitive entry.

Patent-related entry risks are usually secondary.

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How does Penicillin-VK compare with amoxicillin and other oral penicillins (market and competitive positioning)?

Direct answer: Amoxicillin generally has broader use in common outpatient infections and often benefits from higher convenience perception and prescribing familiarity, while Penicillin-VK remains entrenched for specific narrow-spectrum indications. Market value for penicillin-vk tends to lag amoxicillin, but volume can remain meaningful due to guideline continuity.

Competitive substitution patterns

• When stewardship supports narrow spectrum and dosing convenience matters, amoxicillin and cephalexin can capture share.
• Penicillin-VK persists where:
  • local formulary favors it,
  • dosing schedules are acceptable for patient populations,
  • and clinical pathways explicitly include penicillin-class options.

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What are the commercial projections for Penicillin-VK from 2024 to 2029?

Direct answer: Expected commercial trajectory is low single-digit growth in value with flat-to-moderate volume, driven by inflation and mix (tablet vs suspension, strength, and distribution channel) rather than innovation-led demand expansion.

Projection framework

Penicillin-VK economics are driven by:

• Average selling price (ASP) trends and erosion rate under generic competition,
• Formulary share shifts among equivalent narrow-spectrum penicillins,
• Seasonality in respiratory infections,
• Supply reliability affecting ability to meet demand.

Baseline projection (scenario-neutral, directional)

• Volume: stable to modest growth (0%–3% CAGR)
• Value/Revenue: low growth (1%–4% CAGR) with pricing pressure offset by mix and inflation
• Margin: variable by manufacturer and contract pricing; tends to compress under intense competition

(No numeric forecast table is provided because the prompt does not include the market size baseline, channel mix, or geography, and the “no missing data” constraint prevents fabrication.)

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What manufacturing and supply-chain factors could change Penicillin-VK pricing and availability?

Direct answer: For generic antibiotics, price spikes and shortages are typically linked to:

• API availability and fermentation capacity,
• bulk ingredient sourcing,
• manufacturing line transitions and batch release constraints,
• regulatory inspection outcomes at key sites.

Key observables for forecasting

• supplier consolidation in beta-lactam manufacturing,
• procurement lead times,
• changes in DEA/controlled substance adjacent rules are not relevant here; focus stays on cGMP and beta-lactam supply chain.

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Key Takeaways

• Penicillin-VK clinical development is likely dominated by bioequivalence/PK/stability rather than late-stage registrational trials.
• The market remains primarily generic, with competition and prescribing guidelines dictating volume and price.
• Commercial growth is modest and driven by inflation and mix rather than innovation.
• The most material “risk” for commercialization is supply continuity and contract pricing dynamics, not patent expiration.

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FAQs

1. Does Penicillin-VK have active biologic or vaccine-related development programs?
2. Which formulations of Penicillin-VK (tablet vs suspension) typically show the most bioequivalence filings?
3. How do antibiotic stewardship policies influence Penicillin-VK prescribing trends over the next 12 months?
4. What supply-chain disruptions most often impact beta-lactam generic antibiotics like Penicillin-VK?
5. Are there common labeling updates or safety communications that affect Penicillin-VK usage and forecasting?

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. ClinicalTrials.gov. (n.d.). Penicillin V potassium (search results). National Library of Medicine.
3. FDA. (n.d.). Guidance for Industry: Bioequivalence Studies. U.S. Food and Drug Administration.