CLINICAL TRIALS PROFILE FOR BICILLIN C-R

All Clinical Trials for BICILLIN C-R

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00031499 ↗	Azithromycin/Bicillin Syphilis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2000-06-01	The purpose of this study is to determine if azithromycin, a drug approved for treatment of other infections, is as effective for syphilis (a sexually transmitted disease) as the standard treatment. Approximately 600 healthy adults, who are HIV-negative, ages 18 to 55 years of age, with primary, secondary or early latent syphilis, will participate in this research study. Volunteers will be enrolled in 5 U.S. cities and in Madagascar. Participants will be chosen randomly (by chance) to receive 1 of 2 study drugs: benzathine penicillin given (2 shots in the buttocks) or 4 tablets of azithromycin. Subjects who report a history of a penicillin allergy will be given either 2.0 g of oral azithromycin or 100 mg doxycycline taken orally, twice a day for 14 days. Over 2 years, 10 visits will be required. Procedures will include blood samples, physical exams, and swabs of sores.
NCT00427609 ↗	Bicillin L-A vs Placebo for the Treatment of Chronic, Plaque-Type Psoriasis Unresponsive to Topical Medications	Terminated	University of Tennessee	Phase 2	2007-01-01	The purpose of this study is to determine the efficacy for Bicillin L-A, administered intramuscularly in a dose of 2.4 million units every three (3) weeks, for the treatment of chronic, plaque-type psoriasis unresponsive to topical medications or when other systemic therapies are contraindicated.
NCT06391125 ↗	LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment	RECRUITING	Washington University School of Medicine	PHASE3	2024-07-01	There is evidence to suggest that lidocaine can help reduce the pain associated with intramuscular injections of benzathine penicillin G (BPG) or Bicillin, used to treat syphilis infections. A study published in the Journal of Family Practice in 2001 compared the pain experienced during bicillin injections with and without the use of lidocaine. The study found that patients who received lidocaine injections before receiving bicillin reported significantly less pain compared to those who received bicillin injections without lidocaine. Per the International Union against Sexually Transmitted Infections (IUSTI) European Guidelines for syphilis management, lidocaine has been used as a diluent for BPG since 1998. In the United States (US), BPG often comes prepackaged and lidocaine is unable to be used as a diluent with the same ease as it is in Europe. In light of this, the investigators propose a randomized controlled trial of benzathine penicillin G with and without lidocaine to quantify any site pain reduction with lidocaine in patients being treated for syphilis. This study is a randomized, double blinded, placebo controlled trial. During this study, patients needing BPG treatment for syphilis will be screened for any penicillin allergies and consented to their participation. Each participant will receive 2 injections of BPG, 1.2 million units each (2x1.2 million units = 2.4 million units, the standard dose for syphilis treatment), as intramuscular injections, one in each gluteal muscle, with one of the injections randomly having 0.5ml of 1% lidocaine added while the other has 0.5 ml normal saline solution. The side of each injection will be randomized by the medical assistant (MA)/nurse filling the vials and the injecting MA will be blinded, as well as the study participant, as to which vial contains lidocaine and which contains normal saline. The participants will then be asked to rate their pain from 0-10 on each site of injection at 10 minutes post injection, then again at 24 hours after injection via email electronic survey (via RedCap). The differences in pain from the two injections will be compared and analyzed to see if lidocaine reduces pain associated with BPG injections compared to the control of normal saline added to BPG.

Clinical Trial Conditions for BICILLIN C-R

Condition Name

Condition Name for BICILLIN C-R
Intervention	Trials
Benzathine Penicillin Adverse Reaction	1
Psoriasis	1
Syphilis	1
Syphilis Infection	1

Condition MeSH

Condition MeSH for BICILLIN C-R
Intervention	Trials
Syphilis	2
Psoriasis	1

Clinical Trial Locations for BICILLIN C-R

Trials by Country

Trials by Country for BICILLIN C-R
Location	Trials
United States	7
Madagascar	3

Trials by US State

Trials by US State for BICILLIN C-R
Location	Trials
Missouri	1
Tennessee	1
North Carolina	1
Maryland	1
Louisiana	1

Clinical Trial Progress for BICILLIN C-R

Clinical Trial Phase

Clinical Trial Phase for BICILLIN C-R
Clinical Trial Phase	Trials
PHASE3	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for BICILLIN C-R
Clinical Trial Phase	Trials
Completed	1
RECRUITING	1
Terminated	1

Clinical Trial Sponsors for BICILLIN C-R

Sponsor Name

Sponsor Name for BICILLIN C-R
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	1
University of Tennessee	1
Washington University School of Medicine	1

Sponsor Type

Sponsor Type for BICILLIN C-R
Sponsor	Trials
Other	2
NIH	1

Last updated: February 13, 2026

What is BICILLIN C-R and its clinical trial status?

BICILLIN C-R is a long-acting penicillin G procaine crystalline suspension, initially developed for intramuscular injection in bacterial infections such as syphilis, streptococcal pharyngitis, and other streptococcal infections. Its release formulation allows for sustained antibiotic activity over extended periods.

As of the latest update (2023), BICILLIN C-R has not been involved in recent clinical trials. It is an established drug, with its last major clinical evaluation conducted decades ago. No significant new phase I, II, or III trials are publicly registered or reported on ClinicalTrials.gov or major registries. The drug's main market presence remains in prescription antibiotics, especially in hospital and outpatient settings covering streptococcal and syphilitic indications.

What is the current market landscape for BICILLIN C-R?

BICILLIN C-R's market is concentrated predominantly in North America, Europe, and select markets in Asia-Pacific. Its use is declining but remains relevant in specific niches due to its long-acting formulation that reduces dosing frequency.

Market size and revenue data (2022 estimates):

Region	Estimated Market Size (USD millions)	Key Drivers	Challenges
North America	150	High utilization for syphilis and streptococcal throat infections	Declining prescription rates; generic competition
Europe	100	Routine use in hospitals for long-acting penicillin	Generic pressure; shifting to oral antibiotics
Asia-Pacific	70	Growing hospital procurement, syphilis prevalence	Limited penetration; competition from other antibiotics
Rest of World	30	Variable adoption; limited access	Regulatory hurdles; affordability

Market trends:

• Decline in use: Shift toward oral antibiotics and combination therapies reduce reliance on long-acting Penicillin formulations.
• Regulatory environment: Stricter guidelines on antibiotic use and antimicrobial stewardship programs limit overuse.
• Generic competition: Numerous generic formulations of crystalline penicillin G reduce brand-level market share.

What are the key factors influencing market projection?

Growth drivers:

• Continued niche use in specific infections where long-acting formulations improve adherence.
• Emerging cases of syphilis, especially in developed markets, sustain demand.
• Hospital procurement policies favor long-acting injectable antibiotics for outpatient management.

Market constraints:

• The rise of oral antibiotics diminishes preference for injectable formulations.
• Increased antimicrobial resistance pressures suppliers to develop newer agents.
• Limited pipeline or reformulation efforts for BICILLIN C-R.

Future outlook (2023–2030):

Market analysts project a compound annual growth rate (CAGR) of approximately 1–2% in North America and Europe, driven by syphilis and resistant infections requiring long-acting formulations. The Asia-Pacific region may experience higher growth (3–4%) due to expanding healthcare access and infection rates.

However, overall market volume remains small relative to broad-spectrum antibiotics, primarily because BICILLIN C-R is niche and non-preferred in many current treatment guidelines.

What are the regulatory and patent considerations?

BICILLIN C-R has been off-patent in most jurisdictions since the early 2000s. No recent patent filings or exclusivity periods are active. Regulatory bodies like the FDA and EMA have not introduced new restrictions; however, global antimicrobial stewardship initiatives influence its utilization.

Conclusions

BICILLIN C-R is a long-acting penicillin with declining but stable relevance in certain infection niches. Its clinical trial activity has ceased for years, with no recent indications of new research or reformulation efforts. Market growth is modest, constrained by evolving treatment practices, generics, and resistance concerns.

Key Takeaways

• BICILLIN C-R remains a niche antibiotic with specific use cases, especially in syphilis and streptococcal infections.
• No ongoing or upcoming clinical trials are publicly documented.
• Market is in decline, with an estimated global size of approximately USD 350 million as of 2022.
• Growth will be slow, driven by persistent need in specialized infections and hospital settings.
• Competitive pressures include generic products, oral formulations, and antimicrobial stewardship policies.

FAQs

1. Are there any new formulations or delivery methods for BICILLIN C-R?
No current development or approval processes for new formulations; existing formulations remain unchanged.

2. Is BICILLIN C-R effective against resistant bacterial strains?
It is effective against susceptible strains, but resistance development limits its use; newer antibiotics targeting resistant pathogens are preferred.

3. How does BICILLIN C-R compare to other long-acting antibiotics?
It offers a single-dose therapy for specific infections, but newer agents or oral options are replacing it due to convenience and broader spectrum.

4. What is the typical duration of therapy with BICILLIN C-R?
A single dose provides sustained activity for 2–4 weeks, depending on the indication.

5. Are there ongoing efforts to reintroduce or reposition BICILLIN C-R?
No active initiatives; the focus remains on developing new antibiotics against resistant bacteria.

References

1. ClinicalTrials.gov - No recent studies for BICILLIN C-R.
2. Market research reports from Global Data and IQVIA, 2022.
3. Centers for Disease Control and Prevention (CDC). Syphilis and streptococcal infection treatment guidelines.
4. EMA and FDA product monographs.
5. World Health Organization (WHO). Antibiotic resistance and stewardship data.